PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

Phase 4

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peginterferon alfa-2a and Ribavirin

• Registration Number: NCT01056172
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Detailed Description

In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Age older than 18 years old
2. Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
3. Detectable serum quantitative HCV-RNA
4. HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
5. Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

Exclusion Criteria

1. Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
2. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
3. Decompensated liver disease (Child-Pugh class B or C)
4. Neoplastic disease within 5 years
5. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
6. Women with ongoing pregnancy or breast feeding
7. Hgb < 11 g/dL in women or < 12 g/dL in men at screening
8. Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
9. Serum creatinine level > 1.5 times the upper limit of normal at screening
10. Serum alpha-fetoprotein > 100 ng/mL
11. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
12. History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
13. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
14. History of a severe seizure disorder or current anticonvulsant use
15. Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
16. Inability or unwillingness to provide informed consent or abide by the requirements of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B. 16 weeks in RVR patients.	Peginterferon alfa-2a and Ribavirin	Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.
A. 24 weeks in RVR patients.	Peginterferon alfa-2a and Ribavirin	Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (SVR)	24 weeks post-treatment (week 40 or week 48)

Secondary Outcome Measures

Name	Time	Method
AEs	up to 24 weeks after last treatment visit	1. 16 weeks treatment arm: 40 weeks; 2. 24 weeks treatment arm: 48 weeks
laboratory parameters	up to 24 weeks after last treatment visit	1. 16 weeks treatment arm: 40 weeks; 2. 24 weeks treatment arm: 48 weeks
vital signs	up to 24 weeks after last treatment visit	1. 16 weeks treatment arm: 40 weeks; 2. 24 weeks treatment arm: 48 weeks

Trial Locations

Locations (8)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongnam, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of