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Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR

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ClinicalTrials.gov Identifier: NCT00532701
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : June 4, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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 ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Peg-IFN + WB RBV for 16 weeks Drug: Peg-IFN + LD RBV for 16 weeks Drug: Peg-IFN + WB RBV for 24 weeks Drug: Peg-IFN + WB RBV for 48 weeks Drug: Peg-IFN + LD RBV for 24 weeks Phase 4

Detailed Description:
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 ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) RNA levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% vs. 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. We aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peginterferon Alfa-2a Plus Ribavirin in Patients With Genotype 2 Chronic Hepatitis C: A Randomized Study of Treatment Duration and Ribavirin Dose Stratified by Rapid Virologic Response
Study Start Date : November 2007
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Peg-IFN + WB RBV for 16 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-16 in patients with RVR
Drug: Peg-IFN + WB RBV for 16 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
  2. Rapid virologic response (RVR) at week 4 of therapy: achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 5-16
Other Name: Pegasys plus Copegus
Active Comparator: Peg-IFN + LD RBV for 16 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-6, and then low dose ribavirin (800 mg/day) from weeks 6-16 in patients with RVR
Drug: Peg-IFN + LD RBV for 16 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-6
  2. Rapid virologic response (RVR) at week 4 of therapy: achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 6-16
Other Name: Pegasys plus Copegus
Active Comparator: Peg-IFN + WB RBV for 24 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-24 in patients without RVR
Drug: Peg-IFN + WB RBV for 24 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
  2. Rapid virologic response (RVR) at week 4 of therapy: not achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-24
Other Name: Pegasys plus Copegus
Active Comparator: Peg-IFN + WB RBV for 48 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-48 in patients without RVR
Drug: Peg-IFN + WB RBV for 48 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
  2. Rapid virologic response (RVR) at week 4 of therapy: not achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-48
Other Name: Pegasys plus Copegus
Active Comparator: Peg-IFN + LD RBV for 24 weeks
Low dose ribavirin (800 mg/day) from weeks 1-24 in patients with or without RVR
Drug: Peg-IFN + LD RBV for 24 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 1-24
  2. Rapid virologic response (RVR) at week 4 of therapy: both achieved and not achieved
Other Name: Pegasys plus Copegus


Outcome Measures

Primary Outcome Measures :
  1. Sustained virologic response (SVR) [ Time Frame: 1.5 year ]

Secondary Outcome Measures :
  1. Histologic response (HR) [ Time Frame: 1.5 year ]
  2. Biochemical response (BR) [ Time Frame: 1.5 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00532701


Locations
Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliou, Taiwan
Kaohsiung Medical University
Kaohsiung, Taiwan
Kaohsiung Municipal Hsiao-Kang Hospital
Kaohsiung, Taiwan
Paochien Hospital
Pingtung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Buddhist Xindian Tzu Chi General Hospital
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
Ren-Ai Branch, Taipei Municipal Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Principal Investigator: Jia-Horng Kao, MD, PhD National Taiwan University Hospital
Principal Investigator: Ding-Shinn Chen, MD National Taiwan University Hospital
Principal Investigator: Ming-Yang Lai, MD, PhD National Taiwan University Hospital
Principal Investigator: 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 Hospital, Yun-Lin Branch
Principal Investigator: Chih-Lin Lin, MD Taipei City Hospital, Ren-Ai Branch
Principal Investigator: Cheng-Chao Liang, MD Far Eastern Memorial Hospital
Principal Investigator: Ching-Sheng Hsu, MD Buddhist Xindian Tzu Chi General Hospital
Principal Investigator: Sheng-Shun Yang, MD Taichung Veterans General Hospital
Principal Investigator: Chia-Chi Wang, MD Buddhist Xindian Tzu Chi General Hospital
Principal Investigator: Tai-Chung Tseng, MD Buddhist Xindian Tzu Chi General Hospital
Principal Investigator: Ming-Lung Yu, MD, PhD Kaohsiung Medical University
Principal Investigator: Wan-Long Chuang, MD, PhD Kaohsiung Medical University
Principal Investigator: Chia-Yen Dai, MD, Ms Kaohsiung Municipal Hsiao-Kang Hospital
Principal Investigator: Jee-Fu Huang, MD Kaohsiung Municipal Hsiao-Kang Hospital
Principal Investigator: Chang-Fu Chiu, MD Paochien Hospital
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00532701     History of Changes
Other Study ID Numbers: 200709014M
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by National Taiwan University Hospital:
Chronic hepatitis C
Genotype
Interferon
Ribavirin
Genotype 2
Peginterferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs