36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose:

To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with undetectable HCV RNA at wk 8.

Study Design:

a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering this study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

1. Aged 20y/o or older

2. Positive for the HCV antibody and HCV RNA detected with abnormal ALT (≧ 1X) before initiating PegIFN plus RBV treatment

3. HCV Genotype 1

4. Have failed to achieve RVR at week 4 but achieve undetectable HCV RNA at week 8 (< 50 IU/ml) with PegIFN plus RBV treatment

5. Have received PegIFN plus RBV treatment for 12weeks with good compliance (who have received >80% of expected PegIFN and RBV doses and completed at least 80% of the expected duration (80/80/80 adherence) and achieve EVR before entering this study

Exclusion Criteria:

1. Subjects with decompensated liver disease or overt cirrhosis by ultrasound.

2. With prior exposures to interferon (standard or pegylated) treatment before baseline.

3. With human immunodeficiency virus

4. With hepatitis B infection

5. With neutrophil count < 1500 mm3,

6. With platelet count < 90000 mm3,

7. With hemoglobin level < 12g/dL for men or < 11 g/dL for women

8. With serum creatinine level > 1.5 mg/dL

9. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases

10. Female patients with pregnancy or lactation. Pregnancy in partners of male patients.

11. Hypersensitive to study drugs cases.