Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT04365933
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'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': 'C413685', 'term': 'entecavir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment-emergent adverse events', 'timeFrame': '16 weeks', 'description': 'Number of Treatment-emergent adverse events including serious adverse events'}, {'measure': 'Measurement of HBsAg decline', 'timeFrame': '16 weeks', 'description': 'Measurement of HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment period'}], 'secondaryOutcomes': [{'measure': 'Measurement of HBsAg decline', 'timeFrame': '40 weeks', 'description': 'Measurement of HBsAg decline (Δ log10)'}, {'measure': 'Measurement of HBV-DNA decline', 'timeFrame': '40 weeks', 'description': 'Measurement of HBV-DNA decline (Δ log10)'}, {'measure': 'Measurement of HBV-pgRNA decline', 'timeFrame': '40 weeks', 'description': 'Measurement of HBV-pgRNA decline (Δ log10)'}, {'measure': 'Measurement of HBcrAg decline', 'timeFrame': '40 weeks', 'description': 'Measurement of HBcrAg decline (Δ log10)'}, {'measure': 'Concentration of EYP001a - Pharmacokinetic', 'timeFrame': '20 weeks', 'description': 'Assessment of fasted plasma concentrations of EYP001a or any active metabolites using a validated liquid chromatography-mass spectrometry'}, {'measure': 'Concentration of C4 - Pharmacodynamic biomarker', 'timeFrame': '40 weeks', 'description': 'Assessment of concentrations of plasma C4 (7α hydroxy 4 cholesten 3 one)'}, {'measure': 'Concentration of FGF19 - Pharmacodynamic biomarker', 'timeFrame': '40 weeks', 'description': 'Assessment of concentrations of plasma FGF19 over time (Fibroblast Growth Factor 19)'}, {'measure': 'Concentration of Bile Acids - Pharmacodynamic biomarker', 'timeFrame': '40 weeks', 'description': 'Assessment of concentrations over time of plasma Bile Acids (chenodeoxycholic acid, deoxycholic acid, lithocholic acid)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when administered to non-treated (treatment naive or off treatment) chronic Hepatitis B (CHB) patients in combination with entecavir (ETV) and pegylated interferon alpha2a (peg-IFN). An experimental treatment period of 16 weeks will be followed by a 24 week maintenance period with ETV standard of care (SoC).', 'detailedDescription': 'In total 30 eligible patients will be enrolled and randomized at approximately 7 study sites.\n\nPatients will be randomized prior to study drug (EYP001a, ETV and peg-IFN) administration on Day 1 in the ratio of 1:1 into 2 treatment arms:\n\n* Arm 1: EYP001a QD + ETV 0.5 mg QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW (± 3 days) (15 patients)\n* Arm 2: EYP001a QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW (± 3 days) (15 patients)\n\nPatients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 37 days prior to the Day 1 visit. Eligible patients will undergo further assessments on Day 1 to qualify for study drug administration on Day 1.\n\nThe visits during the study are planned as below:\n\n* Screening visit: 5 weeks (37 days)\n* 16 weeks treatment period\n* 24 weeks maintenance period. During maintenance period patients are kept on ETV until the end of the trial at Week 40.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has given voluntary written informed consent before performance of any study related procedure.\n* Are treatment naive or without HBV treatment for at least 60 days or 5 times the elimination half-life, whichever is longer.\n* Patient has CHB:\n\n 1. HBV DNA ≥ 20,000 IU/mL for HBeAg positive and ≥2'000 for HBeAg negative and\n 2. HBsAg ≥ 2.5 log10 IU/mL.\n* Has liver imaging to screen for hepatocellular carcinoma or concomitant pancreaticobiliary disease either in the prior 6 months or at screening.\n* Patient is not of childbearing potential or, if of childbearing potential, is not pregnant as confirmed by a negative serum human chorionic gonadotropin test at screening and is not planning a pregnancy during the course of the study.\n\nExclusion Criteria:\n\n* Is an employee of a clinical research organization, vendor, or Sponsor involved with this study.\n* Has known hepatocellular carcinoma or pancreaticobiliary disease.\n* Neutropenia (defined by two confirmed values during Screening period of \\< 1500/μL).\n* Has Gilbert syndrome.\n* Shows evidence of worsening liver tests, defined as either a confirmed (2 assessments at least 3 days apart) increase \\> 2 ULN ALT or AST or an increase of \\> 1.5 × baseline value of TBL or associated with clinical signs or symptoms of liver impairment.\n* Has known or suspected non-CHB liver disease\n* History of cirrhosis or liver decompensation, including ascites, hepatic encephalopathy, or presence of oesophageal varices.\n* Probable or possible F4 stage with a vibration controlled transient elastography (VCTE) \\> 11.7 kPa leads to exclusion\n* Has known history of alcohol abuse or daily heavy alcohol consumption\n* Has any of the following exclusionary laboratory results at screening:\n\n 1. ALT \\> 2 × ULN, AST \\> 2 × ULN\n 2. INR \\> 1.2 × ULN, (normal range is 0.8 to 1.2)\n 3. Platelet count \\< 100 G/L\n 4. Estimated glomerular filtration rate \\< 50 mL/min/1.73m2 (the Modification of Diet in Renal Disease formula)\n 5. Thyroid-stimulating hormone \\> 1.5 × ULN or abnormal free triiodothyronine or free thyroxine."}, 'identificationModule': {'nctId': 'NCT04365933', 'briefTitle': 'A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enyo Pharma'}, 'officialTitle': 'A Phase 2a Open-label Study of the Oral Farnesoid X Receptor (FXR) Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B (CHB) Patients in Combination With Pegylated Interferon alpha2a (Peg-IFN) Alone and With Entecavir (ETV)', 'orgStudyIdInfo': {'id': 'EYP001-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'EYP001a Dose A QD + ETV 0.5 mg QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW', 'interventionNames': ['Drug: EYP001a', 'Drug: Entecavir', 'Drug: Pegylated interferon alpha2a']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'EYP001a Dose A QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW', 'interventionNames': ['Drug: EYP001a', 'Drug: Pegylated interferon alpha2a']}], 'interventions': [{'name': 'EYP001a', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Entecavir', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['Arm 1']}, {'name': 'Pegylated interferon alpha2a', 'type': 'DRUG', 'description': 'Subcutaneous', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'ENYO PHARMA Investigative site HK01', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'ENYO PHARMA Investigative site KR01', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'ENYO PHARMA Investigative site TW03', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'ENYO PHARMA Investigative site TW04', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'ENYO PHARMA Investigative site TW01', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'ENYO PHARMA Investigative site TW02', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enyo Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}