Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-05 @ 5:26 PM
Study NCT ID:
NCT01641666
Status:
WITHDRAWN
Last Update Posted:
2015-09-09
First Post:
2012-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': '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': 'C512204', 'term': 'N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-07', 'studyFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-13', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virologic Response (SVR)', 'timeFrame': 'Follow-Up Week 24'}, {'measure': 'Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period', 'timeFrame': 'Treatment Week 1 to Treatment Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.', 'detailedDescription': 'Each participant will participate in the trial for a maximum of 80 weeks from the time the participant signs the Informed Consent Form (ICF) through the final contact. After a Screening phase of approximately 4 to 8 weeks, each participant will receive treatment for approximately 36-48 weeks depending on response at Treatment Week 8.\n\nA 4-week lead-in period with PEG2b plus RBV will be followed by 32 weeks boceprevir plus PEG2b/RBV. At treatment Week 36 participants will be assigned to the following treatments depending on the virologic response at Week 8 and cirrhotic status:\n\n1. For non-cirrhotic participants with undetectable hepatitis C virus (HCV)-RNA on Week 8, all treatment will be discontinued at Week 36.\n2. For non-cirrhotic participants with detectable HCV-RNA on Week 8, only boceprevir treatment will be discontinued at Week 36 and PEG2b and RBV treatment will continue to Week 48.\n3. For cirrhotic participants, the boceprevir plus PEG2b/RBV treatment will continue to Week 48.\n\nThe study has a futility rule at Week 12 at which point all subjects with detectable HCV-RNA levels will be discontinued. All participants will have a post-treatment follow-up period of at least 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight ≥ 40 kg to ≤ 125 kg\n* Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception\n* Must have documented Chronic Hepatitis C Genotype 1 infection\n* Must have failed prior treatment with interferon plus ribavirin\n* Must have completed treatment with interferon plus ribavirin for at least 12 weeks\n* Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic\n* Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit\n\nExclusion Criteria:\n\n* Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus\n* Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment\n* Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit\n* Treatment with any investigational drug within 30 days prior to the Screening visit\n* Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit\n* Participation in any investigational trial within 30 days of the Screening visit\n* Evidence of decompensated liver disease\n* Child Pugh score \\> 6 (Class B and C)\n* Diabetic and/or hypertensive participants with clinically significant ocular examination findings\n* Pre-existing psychiatric conditions\n* Clinical diagnosis of substance abuse\n* Active or suspected malignancy\n* Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01641666', 'briefTitle': 'Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam', 'orgStudyIdInfo': {'id': 'P08599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peg2b + Ribavirin + Boceprevir', 'description': 'Peginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5', 'interventionNames': ['Drug: Boceprevir', 'Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': 'Boceprevir will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg.', 'armGroupLabels': ['Peg2b + Ribavirin + Boceprevir']}, {'name': 'Peginterferon Alfa-2b 1.5 mcg/kg/week', 'type': 'DRUG', 'otherNames': ['Pegintron®', 'Rebetol®'], 'description': 'Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week.', 'armGroupLabels': ['Peg2b + Ribavirin + Boceprevir']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol®', 'Pegintron®'], 'description': 'Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID).', 'armGroupLabels': ['Peg2b + Ribavirin + Boceprevir']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}