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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Hepasome Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hepasome Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00703872
First received: June 23, 2008
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: Oral HDV-Interferon + ribavarin
Drug: Injectable HDV-Interferon + ribavarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hepasome Pharmaceuticals:

Primary Outcome Measures:
  • Rapid Virologic Response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early Virologic Response [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Sustained Virologic Response [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral HDV-Interferon
Drug: Oral HDV-Interferon + ribavarin
Naive pateints
Experimental: 2
Injectable HDV-Interferon + ribavarin
Drug: Injectable HDV-Interferon + ribavarin
Nonresponders

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Len Rosenberg, PhD, RPh, Hepasome Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703872     History of Changes
Other Study ID Numbers: HP 01-2006-01
Study First Received: June 23, 2008
Last Updated: January 8, 2009
Health Authority: India: Drugs Controller General of India

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
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014