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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Oral HDV-Interferon + ribavarin Drug: Injectable HDV-Interferon + ribavarin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Oral HDV-Interferon
 Drug: Oral HDV-Interferon + ribavarin
Naive pateints
Experimental: 2
Injectable HDV-Interferon + ribavarin
 Drug: Injectable HDV-Interferon + ribavarin
Nonresponders


Outcome Measures
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Primary Outcome Measures :
  1. Rapid Virologic Response [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Early Virologic Response [ Time Frame: 12 Weeks ]
  2. Sustained Virologic Response [ Time Frame: 24 weeks post-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703872


Locations
India
Global Hospitals
Lakdi-ka-Pool, Hyderabad, India, 500 004
Sponsors and Collaborators
Hepasome Pharmaceuticals
Investigators
Principal Investigator: Dharmesh Kapoor, MD Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India
More Information
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Responsible Party: Len Rosenberg, PhD, RPh, Hepasome Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703872     History of Changes
Other Study ID Numbers: HP 01-2006-01
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by Hepasome Pharmaceuticals:
Chronic Hepatitis C
Naive
Nonresponders
Interferon
Patients with Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents