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

NCT00703872 | Unknown Phase 2

• 1 other identifier: HP 01-2006-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Naive; Nonresponders; Interferon; Patients with Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Rapid Virologic Response

  4 weeks

Secondary Outcomes (2)

• Early Virologic Response

  12 Weeks

• Sustained Virologic Response

  24 weeks post-treatment

Study Arms (2)

1

EXPERIMENTAL

Oral HDV-Interferon

Drug: Oral HDV-Interferon + ribavarin

2

EXPERIMENTAL

Injectable HDV-Interferon + ribavarin

Drug: Injectable HDV-Interferon + ribavarin

Interventions

Oral HDV-Interferon + ribavarin DRUG

Naive pateints

1

Injectable HDV-Interferon + ribavarin DRUG

Nonresponders

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hepasome Pharmaceuticals: lead

Study Sites (1)

Global Hospitals

Lakdi-ka-Pool, Hyderabad, 500 004, India

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dharmesh Kapoor, MD

  Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

IN (1)