Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-30 @ 8:05 AM
Study NCT ID:
NCT01970904
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2013-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'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': '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': 'C499715', 'term': 'alisporivir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral load drop from baseline through Week 12', 'timeFrame': 'Baseline through Week 12'}, {'measure': 'Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg', 'timeFrame': 'within 12 weeks'}, {'measure': 'Change in platelet count from baseline through Week 12.', 'timeFrame': 'Baseline through Week 12'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)', 'timeFrame': '12 weeks after the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis C', 'DEB025', 'Alisporivir', 'ribavirin therapy', 'genotype 2/3 treatment naive patients'], 'conditions': ['Hepatitis C', 'Liver Disease']}, 'descriptionModule': {'briefSummary': 'This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent must be obtained before any assessment is performed.\n2. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)\n3. Chronic hepatitis C (G2 or G3) virus infection diagnosed\n\nExclusion criteria:\n\n1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.\n2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes\n3. Hepatitis B Surface Antigen (HBsAg) positive\n4. Human immunodeficiency virus (HIV) positive.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT01970904', 'briefTitle': 'Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients', 'orgStudyIdInfo': {'id': 'CDEB025A2222'}, 'secondaryIdInfos': [{'id': '2012-004185-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '200 mg BID', 'description': 'Dual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).', 'interventionNames': ['Drug: Alisporivir', 'Drug: Ribavirin', 'Drug: Peg-IFNα2a']}, {'type': 'EXPERIMENTAL', 'label': '300 mg BID', 'description': 'Dual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).', 'interventionNames': ['Drug: Alisporivir', 'Drug: Ribavirin', 'Drug: Peg-IFNα2a']}, {'type': 'EXPERIMENTAL', 'label': '400 mg BID', 'description': 'Dual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).', 'interventionNames': ['Drug: Alisporivir', 'Drug: Ribavirin', 'Drug: Peg-IFNα2a']}], 'interventions': [{'name': 'Alisporivir', 'type': 'DRUG', 'otherNames': ['DEB025'], 'description': 'Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration', 'armGroupLabels': ['200 mg BID', '300 mg BID', '400 mg BID']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['RBV'], 'description': 'Ribavirin tablets of various strengths for oral administration', 'armGroupLabels': ['200 mg BID', '300 mg BID', '400 mg BID']}, {'name': 'Peg-IFNα2a', 'type': 'DRUG', 'description': 'Peg-IFNα2a solution for subcutaneous injection', 'armGroupLabels': ['200 mg BID', '300 mg BID', '400 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10969', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '24146', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '15-540', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '20-079', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '01-201', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE-971 80', 'city': 'Luleå', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': 'GU16 7UJ', 'city': 'Frimley', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}, {'zip': 'B15 2TT', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}