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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00304551 |
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
Condition | Intervention | Phase |
---|---|---|
Liver Cirrhosis Chronic Hepatitis C |
Drug: peginterferon alfa-2a 180μg Drug: peginterferon alfa-2a 90μg Drug: ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC |
Estimated Enrollment: | 180 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: peginterferon alfa-2a 180μg
180μg(s.c.)/week for 48 weeks
Drug: ribavirin
600, 800, or 1,000 mg X 2(p.o.)/day
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2: Experimental |
Drug: peginterferon alfa-2a 90μg
90μg(s.c.)/week for 48 weeks
Drug: ribavirin
600, 800, or 1,000 mg X 2(p.o.)/day
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3: No Intervention |
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Hokkaido Region | |
Hokkaido, Japan | |
Tohoku Region | |
Tohoku, Japan | |
Kanto Region | |
Kanto, Japan | |
Tokai Region | |
Tokai, Japan | |
Kyusyu Region | |
Kyusyu, Japan | |
Chugoku | |
Chugoku, Japan | |
Shikoku Region | |
Shikoku, Japan | |
Kinki Region | |
Kinki, Japan |
Study Director: | Takehiko Aoshima | Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd. |
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | JV19595 |
Study First Received: | March 5, 2006 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00304551 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
CHC with compensated LC |
Antimetabolites Interferon-alpha Anti-Infective Agents Liver Diseases Hepatitis, Chronic Fibrosis Interferons Ribavirin Hepatitis, Viral, Human Liver Cirrhosis |
Angiogenesis Inhibitors Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases Flaviviridae Infections Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Fibrosis Physiological Effects of Drugs Ribavirin Hepatitis, Viral, Human Liver Cirrhosis Pathologic Processes Therapeutic Uses |
Growth Inhibitors Hepatitis C Angiogenesis Modulating Agents RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic |