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

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ClinicalTrials.gov Identifier: NCT00703872
Recruitment Status : Unknown
Verified January 2009 by Hepasome Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2008
Last Update Posted : January 9, 2009
Sponsor:
Information provided by:
Hepasome Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 23, 2008
First Posted Date  ICMJE June 24, 2008
Last Update Posted Date January 9, 2009
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2008)
Rapid Virologic Response [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2008)
  • Early Virologic Response [ Time Frame: 12 Weeks ]
  • Sustained Virologic Response [ Time Frame: 24 weeks post-treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: Oral HDV-Interferon + ribavarin
    Naive pateints
  • Drug: Injectable HDV-Interferon + ribavarin
    Nonresponders
Study Arms  ICMJE
  • Experimental: 1
    Oral HDV-Interferon
    Intervention: Drug: Oral HDV-Interferon + ribavarin
  • Experimental: 2
    Injectable HDV-Interferon + ribavarin
    Intervention: Drug: Injectable HDV-Interferon + ribavarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 23, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00703872
Other Study ID Numbers  ICMJE HP 01-2006-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Len Rosenberg, PhD, RPh, Hepasome Pharmaceuticals
Study Sponsor  ICMJE Hepasome Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dharmesh Kapoor, MD Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India
PRS Account Hepasome Pharmaceuticals
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP