Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Naive, Nonresponders, Interferon, Patients with Chronic Hepatitis C
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 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).
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 by SC route respectively) and ribavirin. * The Part 1 of the study shall assess whether a 4-week treatment course with HDV-Interferon (HDV-IFN), orally or by subcutaneous injection, and ribavirin results 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 and non-responders). Part 2 (continuation part) - 44 or 20 weeks of treatment + 24 weeks (follow-up period): * Patients with hepatitis C viral genotype 1, who achieve RVR, will be treated for another 44 weeks of therapy (to complete 48 weeks of active treatment) followed by 24 weeks of treatment-free follow-up period. * Patients with hepatitis C viral genotype 3, who achieve RVR, will be treated for another 20 weeks of therapy (to complete 24 weeks of active treatment) followed by 24 weeks of treatment-free follow-up period. * Follow-up period (24 weeks): Thus, in addition to treatment in Part 1 of study, each completed patient with viral genotype 1 will receive 44 weeks of therapy and 24 weeks of treatment-free follow-up; and viral genotype 3 patients will have 20 weeks of therapy & 24 weeks of treatment study drug free follow-up. * Overall study duration (72 or 48 weeks): Patients with viral genotype 1 will have an overall study duration of 72 weeks (48 weeks of therapy plus 24 weeks follow-up) and patients with viral genotype 3 will have an overall study duration of 48 weeks (24 weeks of therapy plus 24 weeks follow-up).
Interventions
DRUGOral HDV-Interferon + ribavarin
Naive pateints
DRUGInjectable HDV-Interferon + ribavarin
Nonresponders
Sponsors
Hepasome Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rapid Virologic Response | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Early Virologic Response | 12 Weeks |
| Sustained Virologic Response | 24 weeks post-treatment |
Countries
India
Outcome results
None listed