Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-04-06 @ 4:55 PM
Study NCT ID:
NCT02765802
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2016-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019701', 'term': 'Hepatitis D, Chronic'}], 'ancestors': [{'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600496', 'term': 'peginterferon lambda-1a'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@eigerbio.com', 'phone': '1-650-618-1621', 'title': 'SVP, Clinical Development', 'organization': 'Eiger BioPharmaceuticals, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks.', 'description': 'Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.', 'eventGroups': [{'id': 'EG000', 'title': 'Lambda 180 μg', 'description': 'Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Lambda 120 μg', 'description': 'Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine Aminotransferase (ALT) increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate Aminotransferase (AST) Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'gamma-glutamyl transferase (GGT) increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'international normalized ratio (INR) increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug-Induced Liver Injury (DILI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HDV Viral Load.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lambda 180 μg', 'description': 'Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A'}, {'id': 'OG001', 'title': 'Lambda 120 μg', 'description': 'Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.14', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '2.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48 (end of treatment)', 'description': 'To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period.\n\nTo evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.', 'unitOfMeasure': 'Change in HDV RNA log IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HDV Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lambda 180 μg', 'description': 'Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A'}, {'id': 'OG001', 'title': 'Lambda 120 μg', 'description': 'Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.70', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 72 (end of follow-up)', 'description': 'To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment', 'unitOfMeasure': 'Change in HDV RNA log IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Durable Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Lambda-1A 180 μg', 'description': 'Patients chronically infected with HDV who are randomized to the Peginterferon Lambda-1A 180 μg arm'}, {'id': 'OG001', 'title': 'Peginterferon Lambda-1A 120 μg', 'description': 'Patients chronically infected with HDV who are randomized to the Peginterferon Lambda-1A 120 μg arm'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 72', 'description': 'Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lambda 180 μg', 'description': 'Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A'}, {'id': 'FG001', 'title': 'Lambda 120 μg', 'description': 'Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.\n\nPeginterferon Lambda-1A'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peginterferon Lambda-1A 180 μg', 'description': 'Peginterferon Lambda-1A (Lambda) 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.'}, {'id': 'BG001', 'title': 'Peginterferon Lambda-1A 120 μg', 'description': 'Peginterferon Lambda-1A (Lambda) 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '63'}, {'value': '36.6', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '63'}, {'value': '39.7', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Pakistan', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'log HDV RNA', 'classes': [{'categories': [{'measurements': [{'value': '3.86', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '7.3'}, {'value': '4.15', 'groupId': 'BG001', 'lowerLimit': '0.5', 'upperLimit': '6.1'}, {'value': '4.03', 'groupId': 'BG002', 'lowerLimit': '0.5', 'upperLimit': '7.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log IU/mL', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-22', 'size': 1074975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-02T15:36', 'hasProtocol': True}, {'date': '2020-04-01', 'size': 997437, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-02T15:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'dispFirstSubmitDate': '2019-07-17', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2016-05-05', 'dispFirstSubmitQcDate': '2019-07-17', 'resultsFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2016-05-06', 'dispFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-20', 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HDV Viral Load.', 'timeFrame': 'Week 48 (end of treatment)', 'description': 'To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period.\n\nTo evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HDV Viral Load', 'timeFrame': 'Week 72 (end of follow-up)', 'description': 'To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment'}, {'measure': 'Number of Patients With a Durable Virologic Response', 'timeFrame': 'Week 72', 'description': 'Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis D, Chronic']}, 'referencesModule': {'references': [{'pmid': '12483210', 'type': 'BACKGROUND', 'citation': 'Kotenko SV, Gallagher G, Baurin VV, Lewis-Antes A, Shen M, Shah NK, Langer JA, Sheikh F, Dickensheets H, Donnelly RP. IFN-lambdas mediate antiviral protection through a distinct class II cytokine receptor complex. Nat Immunol. 2003 Jan;4(1):69-77. doi: 10.1038/ni875. Epub 2002 Dec 16.'}, {'pmid': '12469119', 'type': 'BACKGROUND', 'citation': 'Sheppard P, Kindsvogel W, Xu W, Henderson K, Schlutsmeyer S, Whitmore TE, Kuestner R, Garrigues U, Birks C, Roraback J, Ostrander C, Dong D, Shin J, Presnell S, Fox B, Haldeman B, Cooper E, Taft D, Gilbert T, Grant FJ, Tackett M, Krivan W, McKnight G, Clegg C, Foster D, Klucher KM. IL-28, IL-29 and their class II cytokine receptor IL-28R. Nat Immunol. 2003 Jan;4(1):63-8. doi: 10.1038/ni873. Epub 2002 Dec 2.'}, {'pmid': '20051970', 'type': 'BACKGROUND', 'citation': 'Wedemeyer H, Manns MP. Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead. Nat Rev Gastroenterol Hepatol. 2010 Jan;7(1):31-40. doi: 10.1038/nrgastro.2009.205.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.', 'detailedDescription': "Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway that leads to broad-spectrum antiviral activities. Since IFN-α has demonstrated anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it is postulated that pegylated IFN-λ could also induce HDV ribonucleic acid (RNA) decline in patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data from studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or hepatitis C virus (HCV), it is postulated that Lambda treatment could be associated with fewer adverse effects than IFN-α treatment. This Phase II study is designed as randomized, open-label study of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in patients with chronic HDV infection, and the primary objectives of the study are as follows:\n\n* To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48-week treatment period.\n* To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic HDV infection of at least 6 months' duration documented by a positive HDV antibody (Ab) test, detectable and quantifiable HDV RNA by qPCR at study entry\n* Serum alanine aminotransferase (ALT) \\> upper limit of the normal range (ULN) and \\<10 × ULN at screening\n* Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a QT interval corrected for heart rate (QTcF) \\<450 ms for male patients and \\<460 ms for female patients\n* Thyroid-stimulating hormone (TSH) and/or free T4 within 0.8 to 1.2 × ULN, or adequately controlled thyroid function as assessed by the investigator.\n* Dilated retinal examination ≤1 year before screening\n* Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication\n\nExclusion Criteria:\n\nGeneral Exclusions:\n\n* Participation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFNs) or immunomodulators within 12 months before screening\n* Previous use of Lambda. Patients who previously participated in a clinical trial of Lambda but are confirmed to have received placebo or other non-Lambda IFNs are allowed.\n* History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.\n* Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.\n\nExclusions Based on Disease\n\n* Current or previous history of decompensated liver disease (Child-Pugh Class B or C)\n* Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)\n* Past history or current evidence of decompensated liver disease, defined as any of the following at screening:\n\n 1. Bilirubin level ≥ 2.5 mg/dL unless due to Gilbert's disease\n 2. Serum albumin level \\<3.5 g/dL\n 3. International normalized ratio (INR) ≥1.5\n 4. Alpha fetoprotein ≥100 ng/mL\n* Evidence of significant portal hypertension; current presence or history of variceal bleeding, ascites requiring diuretics or paracentesis, or hepatic encephalopathy\n* Any of the following abnormal laboratory test results at screening:\n\n 1. Platelet count \\<90,000 cells/mm\\^3\n 2. White blood cell count \\<3,000 cells/mm\\^3\n 3. Absolute neutrophil count \\<1,500 cells/mm\\^3\n 4. Hemoglobin \\<11 g/dL for women and \\<12 g/dL for men\n 5. Serum creatinine concentration ≥1.5× ULN\n 6. Confirmed creatinine clearance (CrCl) \\< 50 mL/min by Cockcroft-Gault\n* Evidence of another form of viral hepatitis or another form of liver disease\n* History of hepatocellular carcinoma\n* Patients with any of the following:\n\n 1. Current eating disorder or alcohol abuse\n 2. Excessive alcohol intake\n 3. In the opinion of the investigator, an alcohol use pattern that will interfere with study conduct\n 4. Drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives\n* Prior history or current evidence of any of the following:\n\n 1. Immunologically mediated disease\n 2. Retinal disorder or clinically relevant ophthalmic disorder\n 3. Any malignancy within 5 years before screening\n 4. Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease.\n 5. Chronic pulmonary disease\n 6. Pancreatitis\n 7. Severe or uncontrolled psychiatric disorder\n 8. Active seizure disorder\n 9. Bone marrow or solid organ transplantation\n* Other significant medical condition that may require intervention during the study\n\nExclusions Based on Concurrent Medication Use\n\n* Therapy with an immunomodulatory agent\n* Use of telbivudine\n* Current use of heparin or Coumadin\n* Received blood products within 30 days before study randomization\n* Use of hematologic growth factors within 30 days before study randomization\n* Systemic antibiotics, antifungals, or antivirals for treatment of active infection other than HBV within 14 days before study randomization\n* Any prescription or herbal product that is not approved by the investigator\n* Long-term treatment (\\> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor\n* Receipt of systemic immunosuppressive therapy within 3 months before screening"}, 'identificationModule': {'nctId': 'NCT02765802', 'acronym': 'LIMT', 'briefTitle': 'A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eiger BioPharmaceuticals'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (LIMT)', 'orgStudyIdInfo': {'id': 'EIG-LMD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lambda 180 μg', 'description': 'Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.', 'interventionNames': ['Drug: Peginterferon Lambda-1A']}, {'type': 'EXPERIMENTAL', 'label': 'Lambda 120 μg', 'description': 'Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.', 'interventionNames': ['Drug: Peginterferon Lambda-1A']}], 'interventions': [{'name': 'Peginterferon Lambda-1A', 'type': 'DRUG', 'otherNames': ['Lambda'], 'armGroupLabels': ['Lambda 120 μg', 'Lambda 180 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '9103102', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '1142', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '74800', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'The Aga Khan University and Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'David Apelian, MD, PhD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eiger BioPharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eiger BioPharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}