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Sponsors and Collaborators: |
Schering-Plough Integrated Therapeutics Group |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00441584 |
This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PEGIntron plus REBETOL.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: Combination of pegylated interferon alfa-2b and ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of PEG-Intron Plus Rebetol in Subjects With Chronic Hepatitis C Genotype 1 Non Responder to Pegasys |
Estimated Enrollment: | 200 |
Study Start Date: | April 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PEG-Intron and Rebetol combination therapy: Experimental |
Drug: Combination of pegylated interferon alfa-2b and ribavirin
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods:
Compensated liver disease with the following minimum hematologic and biochemical criteria at the Day 1 visit within normal limits:
Subject must be a non-responder, defined as having received and not having responded to a prior treatment consisting of one course of Pegasys 180 mcg QW in combination with ribavirin 1000-1200 mg daily, with or without amantadine, for a minimum of 12 weeks and:
Exclusion Criteria:
Subject has any of the following causes for the liver disease based on subject history or biopsy (where applicable) other than chronic hepatitis C, including but not limited to:
Subject has any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study as followed below:
Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:
Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the subject; this management plan will become a part of the subject's medical record.
Responsible Party: | Schering-Plough ( Edward Power, PhD - Senior Global Medical Director, Global Medical Affairs ) |
Study ID Numbers: | P03833, ESPECIAL |
Study First Received: | February 28, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00441584 |
Health Authority: | Austria: Federal Ministry for Health and Women; Canada: Health Canada; Belgium: Ministry of Social Affairs, Public Health and the Environment; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Italy: The Italian Medicines Agency; Spain: Ministry of Health; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Peginterferon alfa-2b Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |