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

NCT00703872 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-01-09

No results posted yet for this study

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

Interventions

DRUG

Oral HDV-Interferon + ribavarin

Naive pateints

DRUG

Injectable HDV-Interferon + ribavarin

Nonresponders

Sponsors & Collaborators

  • Hepasome Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Dharmesh Kapoor, MD · Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703872 on ClinicalTrials.gov