Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00709059
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2008-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], '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': '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The participating physician (PP) agrees not to publish/present any\n\ninterim results of the Survey without prior written consent of Schering-\n\nPlough (SP). The PP further agrees to provide 30 days written notice to SP prior to submission for publication or presentation to permit SP to review and comment on any presentation, which right shall include editorial rights. If the parties disagree, the PP agrees to meet with SP to discuss and resolve any such issues or disagreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Per protocol, non-serious adverse events and serious adverse events were not required to be captured as part of the study database.', 'eventGroups': [{'id': 'EG000', 'title': 'PegIntron Plus Rebetol', 'description': 'Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Study Participants Who Had a Virological Response (VR) at Week-72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PegIntron Plus Rebetol', 'description': 'Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Week 72', 'description': 'VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.\n\nParticipants who dropped out or were withdrawn from treatment were considered not to respond.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PegIntron Plus Rebetol', 'description': 'Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '538'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Disease complication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Side effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Serious side effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PegIntron Plus Rebetol', 'description': 'Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50 years', 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}]}]}, {'title': '>=50 years', 'categories': [{'measurements': [{'value': '204', 'groupId': 'BG000'}]}]}, {'title': 'age not available', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}]}]}, {'title': 'Gender not available', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 538}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2008-06-23', 'resultsFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-22', 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Study Participants Who Had a Virological Response (VR) at Week-72', 'timeFrame': 'Treatment Week 72', 'description': 'VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.\n\nParticipants who dropped out or were withdrawn from treatment were considered not to respond.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C'], 'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Previously untreated patients with chronic hepatitis C, infected with HCV genotype 1, 4, 5, or 6, receiving treatment with PegIntron and Rebetol.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol\n* Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)\n* Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \\[ALT\\]) levels above the upper normal limit for gender\n* Documented chronic hepatitis C (CHC) of genotype 1/4/5/6\n* A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4\n\nExclusion Criteria:\n\n* Known hypersensitivity for any active ingredient or constituent\n* Pregnancy or lactation\n* Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt\n* Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months\n* Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \\<50 mL/minute\n* Hepatitis of immunologic origin or medically documented history of auto-immune disease\n* Severe hepatic disorder or decompensated cirrhosis\n* Pre-existing thyroid disorder, except if under control with classical treatment\n* Epilepsy or central nervous system disorder\n* Hemoglobin pathology, eg, thalassaemia, sickle cell anemia"}, 'identificationModule': {'nctId': 'NCT00709059', 'acronym': 'PRACTICE', 'briefTitle': 'Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)', 'orgStudyIdInfo': {'id': 'P04243'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PegIntron Plus Rebetol', 'description': 'Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.', 'interventionNames': ['Biological: PegIntron (peginterferon alfa-2b; SCH 54031)', 'Drug: Rebetol (ribavirin; SCH 18908)']}], 'interventions': [{'name': 'PegIntron (peginterferon alfa-2b; SCH 54031)', 'type': 'BIOLOGICAL', 'otherNames': ['SCH 54031'], 'description': 'PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks', 'armGroupLabels': ['PegIntron Plus Rebetol']}, {'name': 'Rebetol (ribavirin; SCH 18908)', 'type': 'DRUG', 'otherNames': ['SCH 18908'], 'description': 'Rebetol administered based on body weight 800-1200 mg/day (\\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \\>85 kg: 1200 mg) orally for 48 weeks', 'armGroupLabels': ['PegIntron Plus Rebetol']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}