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

Chronic Hepatitis C Clinical Trial

Official title:

An Evaluation of Two Dose Routes of HDV-Interferon Administered With Ribavarin in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00703872
• Other study ID #: HP 01-2006-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 23, 2008
• Last updated: January 8, 2009
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Hepasome Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Oral HDV-Interferon + ribavarin
Naive pateints
• Injectable HDV-Interferon + ribavarin
Nonresponders

Locations

Country	Name	City	State
India	Global Hospitals	Lakdi-ka-Pool	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
Hepasome Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid Virologic Response		4 weeks	No
Secondary	Early Virologic Response		12 Weeks	No
Secondary	Sustained Virologic Response		24 weeks post-treatment	No