Status:
UNKNOWN
HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients
Lead Sponsor:
Hepasome Pharmaceuticals
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 eff...
Detailed Description
Part 1 ("initial part") - 4 weeks of treatment (28 days): * All patients will complete an initial 4 weeks of treatment with HDV-Interferon (HDV-IFN) (treatment naïve by oral route and non-responders ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00703872
Start Date
May 1 2008
End Date
December 1 2009
Last Update
January 9 2009
Active Locations (1)
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1
Global Hospitals
Lakdi-ka-Pool, Hyderabad, India, 500 004