Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients
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ClinicalTrials.gov Identifier: NCT00495131 |
Recruitment Status :
Completed
First Posted : July 2, 2007
Results First Posted : September 7, 2009
Last Update Posted : September 10, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic | Drug: Pegylated interferon alfa-2a plus ribavirin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 308 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Genotype 1-infected Patients in Taiwan |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Peginterfron and ribavirin (24 weeks)
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
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Drug: Pegylated interferon alfa-2a plus ribavirin
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
Other Name: Pegasys plus Robatrol |
Active Comparator: Peginterferon and ribavirin (48 weeks)
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
|
Drug: Pegylated interferon alfa-2a plus ribavirin
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
Other Name: Pegasys plus Robatrol |
- Sustained Virologic Response [ Time Frame: 18 months ]Undetectable HCV RNA 6 months off therapy
- Sustained Biochemical Response [ Time Frame: 18 months ]Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization
- Treatment-related Withdrawal Rate [ Time Frame: 18 months ]Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events
- Histologic Response [ Time Frame: 18 months ]Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Treatment naïve
- Age 18 and older than 18 years old
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
- Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with dynamic range 600~<500,000 IU/ml
- HCV genotype 1 (Inno-LiPA HCV II, Innogenetics, Ghent, Belgium)
- Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
- A liver biopsy consistent with the diagnosis of chronic hepatitis C
Exclusion Criteria:
- Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
- Neutropenia (neutrophil count <1,500 per cubic milliliter)
- Thrombocytopenia (platelet <90,000 per cubic milliliter)
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Chronic alcohol abuse (daily consumption > 20 gram per day)
- Decompensated liver disease (Child-Pugh class B or C)
- Serum creatinine level more than 1.5 times the upper limit of normal
- Autoimmune liver disease
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495131
Taiwan | |
National Taiwan University Hospital, Yun-Lin Branch | |
Douliou, Taiwan | |
Taichung Veterans General Hospital | |
Taichung, Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan, 100 | |
Buddhist Tzu Chi General Hospital | |
Taipei, Taiwan | |
Far Eastern Memorial Hospital | |
Taipei, Taiwan | |
Ren-Ai Branch, Taipei Municipal Hospital | |
Taipei, Taiwan |
Study Chair: | Jia-Horng Kao, MD, PhD | National Taiwan University Hospital | |
Study Director: | Ding-Shinn Chen, MD | National Taiwan University Hospital | |
Study Director: | Ming-Yang Lai, MD, PhD | National Taiwan University Hospital | |
Study Director: | Pei-Jer Chen, MD, PhD | National Taiwan University Hospital | |
Principal Investigator: | Chun-Jen Liu, MD, PhD | National Taiwan University Hospital | |
Principal Investigator: | Chen-Hua Liu, MD | National Taiwan University Hospital | |
Principal Investigator: | Shih-Jer Hsu, MD | National Taiwan University Hosptial, Yun-Lin Branch | |
Principal Investigator: | Chih-Lin Lin, MD | Ren-Ai Branch, Taipei City Hospital | |
Principal Investigator: | Cheng-Chao Liang, MD | Far Eastern Memorial Hospital | |
Principal Investigator: | Ching-Sheng Hsu, MD | Buddhist Tzu Chi General Hospital | |
Principal Investigator: | Sheng-Shun Yang, MD | Taichung Veterans General Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Jia-Horng Kao, National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00495131 |
Other Study ID Numbers: |
200705080M |
First Posted: | July 2, 2007 Key Record Dates |
Results First Posted: | September 7, 2009 |
Last Update Posted: | September 10, 2009 |
Last Verified: | September 2009 |
Chronic hepatitis C Genotype 1 Interferon Ribavirin |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic |
Interferons Ribavirin Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |