Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR
Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Sep 18, 2007
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Treatment naïve
- • Age 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 Taqman HCV Monitor v2.0, Roche Diagnostics) with dynamic range 25 \~ 391000000 IU/ml
- • HCV genotype 2 (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 grams per deciliter for men and \< 12 grams per deciliter for women)
- • Neutropenia (neutrophil count \< 1,500 per cubic milliliter)
- • Thrombocytopenia (platelets \< 90,000 per cubic milliliter)
- • Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- • Chronic alcohol abuse (daily consumption \> 20 grams 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 use contraception
- • Unwilling to sign informed consent
About National Taiwan University Hospital
National Taiwan University Hospital (NTUH) is a leading medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a pioneer in medical education and patient care in Taiwan, NTUH integrates cutting-edge technology with comprehensive clinical expertise to facilitate groundbreaking studies across various medical fields. The hospital’s dedicated research team collaborates with local and international partners to enhance the understanding of diseases and improve treatment outcomes. By prioritizing patient safety and ethical standards, NTUH strives to contribute to the global medical community and foster advancements in healthcare practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taipei, , Taiwan
Taipei, , Taiwan
Douliou, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Kaohsiung, , Taiwan
Kaohsiung, , Taiwan
Pingtung, , Taiwan
Taipei, , Taiwan
Patients applied
Trial Officials
Jia-Horng Kao, MD, PhD
Principal Investigator
National Taiwan University Hospital
Ding-Shinn Chen, MD
Principal Investigator
National Taiwan University Hospital
Ming-Yang Lai, MD, PhD
Principal Investigator
National Taiwan University Hospital
Pei-Jer Chen, MD, PhD
Principal Investigator
National Taiwan University Hospital
Chun-Jen Liu, MD, PhD
Principal Investigator
National Taiwan University Hospital
Chen-Hua Liu, MD
Principal Investigator
National Taiwan University Hospital
Shih-Jer Hsu, MD
Principal Investigator
National Taiwan University Hospital, Yun-Lin Branch
Chih-Lin Lin, MD
Principal Investigator
Taipei City Hospital, Ren-Ai Branch
Cheng-Chao Liang, MD
Principal Investigator
Far Eastern Memorial Hospital
Ching-Sheng Hsu, MD
Principal Investigator
Buddhist Xindian Tzu Chi General Hospital
Sheng-Shun Yang, MD
Principal Investigator
Taichung Veterans General Hospital
Chia-Chi Wang, MD
Principal Investigator
Buddhist Xindian Tzu Chi General Hospital
Tai-Chung Tseng, MD
Principal Investigator
Buddhist Xindian Tzu Chi General Hospital
Ming-Lung Yu, MD, PhD
Principal Investigator
Kaohsiung Medical University
Wan-Long Chuang, MD, PhD
Principal Investigator
Kaohsiung Medical University
Chia-Yen Dai, MD, Ms
Principal Investigator
Kaohsiung Municipal Hsiao-Kang Hospital
Jee-Fu Huang, MD
Principal Investigator
Kaohsiung Municipal Hsiao-Kang Hospital
Chang-Fu Chiu, MD
Principal Investigator
Paochien Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials