Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-30 @ 6:47 AM
Study NCT ID:
NCT00724295
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1077}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall incidence of adverse events and adverse drug reactions.', 'timeFrame': 'From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.'}, {'measure': 'Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.', 'timeFrame': 'From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.'}, {'measure': 'Sustained virologic response rate and improvement of ALT (alanine transaminase).', 'timeFrame': 'Assessed at the end-of-treatment and at 24 weeks post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients.\n\nPost-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in the clinical practice at approximately 100 to 200 institutions in Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with chronic hepatitis C.\n\n* Patients are serogroup 1(genotype I (1a) or II (1b)).\n* The HCV-RNA level in the blood is more than 10\\^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity to test drugs or other interferon preparations\n* Patients with a history of hypersensitivity to biological products, such as vaccines\n* Patients being treated with Shosaikoto\n* Patients with autoimmune hepatitis\n* Pregnant women, women who may be pregnant, and nursing mothers\n* Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)\n* Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)\n* Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)\n* Patients with chronic renal failure or renal function disorder with creatinine clearance of \\<=50 mL/min\n* Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt\n* Patients with serious hepatic dysfunction\n* Patients with autoimmune hepatitis'}, 'identificationModule': {'nctId': 'NCT00724295', 'briefTitle': 'Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'PEG Intron/REBETOL Combination Therapy Special Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C-', 'orgStudyIdInfo': {'id': 'P04505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Overall study population', 'interventionNames': ['Drug: peginterferon alfa-2b', 'Drug: ribavirin']}], 'interventions': [{'name': 'peginterferon alfa-2b', 'type': 'DRUG', 'otherNames': ['PegIntron', 'SCH 54031'], 'description': 'PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.', 'armGroupLabels': ['Arm 1']}, {'name': 'ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol', 'SCH 18908'], 'description': 'Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.', 'armGroupLabels': ['Arm 1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}