HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve by oral route and non-responders by SC route respectively).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hepasome Pharmaceuticals
• Treatments: Interferons

Criteria

Inclusion Criteria - Nonresponders:

• Patients >18 years with established chronic hepatitis C with viral genotype 1 or viral genotype 3 who have failed to respond to at least a 3-month course of a pegylated interferon alpha 2a + ribavirin and have a detectable HCV RNA and baseline liver biopsy available from within the prior 12 months.

Inclusion Criteria - Naive:

• Treatment naïve patients > 18 years, inclusive, are eligible for this study.

• Patients will be viral genotype 1 or viral genotype 3, have quantifiable HCV-RNA > 1000 IU/mL as demonstrated by PCR and an abnormal ALT (within 6 months of screening) and compensated liver disease with or without cirrhosis.

Exclusion Criteria - Nonresponders:

• Patients with decompensated cirrhosis or other forms of liver disease

• Hb < 10g/dL for males & Hb < 9 g/dl for females

• hepatocellular carcinoma

• active hepatitis B infection

• human immunodeficiency virus (HIV)

• pre-existing severe or uncontrolled depression or other psychiatric disease

• significant cardiac disease

• renal disease

• seizure disorders or retinopathy

Exclusion Criteria - Nonresponders:

• Patients with decompensated cirrhosis or other forms of liver disease

• Hb < 10g/dL for males & Hb < 9 g/dl for females

• hepatocellular carcinoma

• active hepatitis B infection

• HIV

• pre-existing severe or uncontrolled depression or other psychiatric disease - significant cardiac disease

• renal disease

• seizure disorders or retinopathy