Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-28 @ 12:20 PM
Study NCT ID:
NCT01217632
Status:
TERMINATED
Last Update Posted:
2016-08-16
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C560078', 'term': 'pamrevlumab'}, {'id': 'C413685', 'term': 'entecavir'}, {'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'whyStopped': 'Study terminated due to an unexpected prominent effect of entecavir alone in this patient population.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the efficacy of FG-3019 administered every 3 weeks for 45 weeks on liver fibrosis in subjects with chronic active hepatitis B infection on entecavir therapy', 'timeFrame': 'every 3 weeks for 45 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population', 'timeFrame': 'every 3 weeks for 45 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Connective tissue growth factor (CTGF)', 'human IgG1 monoclonal antibody'], 'conditions': ['Liver Fibrosis Due to Chronic Hepatitis B Infection']}, 'descriptionModule': {'briefSummary': 'The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who are eligible for antiviral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Signed informed consent\n* Age of 18 to 75 years, inclusive\n* HBsAg positive for ≥24 weeks prior to screening\n* Liver fibrosis, confirmed by biopsy and histology\n* Willing to use contraception\n\nExclusion Criteria:\n\n* Female subjects who are pregnant or nursing\n* Prior antiviral therapy, with the exception of interferon therapy \\>6 months prior to Day 1\n* Severe heart failure\n* Present hepatocellular carcinoma and history of other cancers\n* Severe anemia\n* Advanced kidney disease\n* Immunosuppressive therapy within 24 weeks prior to screening\n* Alcohol or drug abuse within the 12 months prior to screening\n* Trauma or surgical procedures requiring hospitalization within 8 weeks prior to Day 1\n* Planned elective surgery during the study including 9 weeks following the final dose of study drug\n* History of allergy against nucleoside analogs or human, humanized, chimeric, or murine monoclonal antibodies\n* Inability to cooperate with study personnel or a history of noncompliance to the medical regimen (i.e., subjects who would be expected to comply poorly with the treatment)\n* Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study\n* Morbid obesity (body mass index \\[BMI\\] \\>40)\n* Inadequate IV access'}, 'identificationModule': {'nctId': 'NCT01217632', 'briefTitle': 'A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'FibroGen'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection', 'orgStudyIdInfo': {'id': 'FGCL-3019-801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'FG-3019 Placebo', 'description': 'Placebo will be administered at 15-45 mg/kg every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.', 'interventionNames': ['Drug: Placebo', 'Drug: Entecavir']}, {'type': 'EXPERIMENTAL', 'label': 'FG-3019', 'description': 'FG-3019 at a dose of 15-45 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.', 'interventionNames': ['Drug: FG-3019', 'Drug: Entecavir']}], 'interventions': [{'name': 'FG-3019', 'type': 'DRUG', 'description': 'FG-3019 at a dose of 15-45 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.', 'armGroupLabels': ['FG-3019']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.', 'armGroupLabels': ['FG-3019 Placebo']}, {'name': 'Entecavir', 'type': 'DRUG', 'otherNames': ['Entecavir Dispersible (generic)'], 'armGroupLabels': ['FG-3019', 'FG-3019 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pokfulam', 'state': 'Hong Kong Island', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital'}, {'city': 'Wan Chai', 'state': 'Hong Kong Island', 'country': 'Hong Kong', 'facility': 'Ruttonjee Hospital', 'geoPoint': {'lat': 22.28142, 'lon': 114.17258}}, {'city': 'Kowloon', 'state': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}, {'city': 'Shatin', 'state': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'New Territories', 'state': 'New Territories', 'country': 'Hong Kong', 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.42441, 'lon': 114.11095}}, {'city': 'Tai Po', 'country': 'Hong Kong', 'facility': 'Alice Ho Miu Ling Nethersole Hospital', 'geoPoint': {'lat': 22.45007, 'lon': 114.16877}}, {'zip': '10700', 'city': 'Siriaj', 'state': 'Bangkok Noi', 'country': 'Thailand', 'facility': 'Siriraj Hospital'}, {'zip': '90110', 'city': 'Amphur Hatyai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Songklanagarind Hospital'}, {'zip': '50200', 'city': 'Amphur Muang', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Maharaj Nakorn Chiang Mai Hospital'}], 'overallOfficials': [{'name': 'Frank Valone, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'FibroGen'}, {'name': 'Mairead Carney', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FibroGen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FibroGen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}