Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 1:13 PM
Study NCT ID:
NCT01727934
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2012-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'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': 'C581159', 'term': 'miravirsen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-03', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Viral resistance analysis at baseline and throughout the study.', 'timeFrame': '60 weeks', 'description': 'The miR-122 seed sites in HCV RNA from subjects at baseline and following viral breakthrough or relapse will be subjected to genotypic sequence analysis.'}, {'measure': 'Plasma pharmacokinetics', 'timeFrame': '28 weeks', 'description': 'Plasma PK for miravirsen levels will be determined for up to 2 hours post-dose on Day 1, up to 24 hours post-dose on Days 29 and 84, and pre-dose for all other treatment period visits. Additionally, plasma PK will be evaluated at all follow-up visits through Week 28.'}, {'measure': 'Urine pharmacokinetics', 'timeFrame': 'Up to 24 hours post-dose on Day 29 and Day 84'}], 'primaryOutcomes': [{'measure': 'The proportion of subjects with sustained virological response 24 weeks after the end of therapy.', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.', 'timeFrame': '60 weeks'}, {'measure': 'The proportion of subjects with undetectable HCV RNA levels at the end of treatment.', 'timeFrame': '12 weeks'}, {'measure': 'Change in HCV RNA levels from baseline throughout the study.', 'timeFrame': '60 weeks'}, {'measure': 'The proportion of subjects who experience virological failure throughout the study.', 'timeFrame': '60 weeks'}, {'measure': 'Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).', 'timeFrame': '60 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antisense', 'miR-122 antagonist', 'host factor', 'Chronic hepatitis C', 'Hepatitis C'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic hepatitis C\n* HCV genotype 1\n* BMI 18-38 kg/m2\n* Null responder to pegylated interferon alpha and ribavirin\n\nExclusion Criteria:\n\n* Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)\n* Significant liver disease in addition to hepatitis C\n* Decompensated liver disease medical history or current clinical features\n* Histologic evidence of hepatic cirrhosis\n* Concurrent clinically significant medical diagnosis (other than CHC)\n* Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)\n* Clinically significant illness within 30 days preceding entry into the study\n* Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication\n* History of clinically significant allergic drug reactions'}, 'identificationModule': {'nctId': 'NCT01727934', 'briefTitle': 'Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santaris Pharma A/S'}, 'officialTitle': 'A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection', 'orgStudyIdInfo': {'id': 'SPC3649-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miravirsen sodium', 'description': 'Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg.', 'interventionNames': ['Drug: Miravirsen sodium']}], 'interventions': [{'name': 'Miravirsen sodium', 'type': 'DRUG', 'otherNames': ['SPC3649'], 'description': 'Subcutaneous injection', 'armGroupLabels': ['Miravirsen sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Fundacion de Investigation de Diego', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Maribel Rodriguez-Torres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion de Investgacion de Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santaris Pharma A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}