drugset / Trial / NCT00703872

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

NCT00703872 ↗

Phase 2 Unknown 50 enrolled Hepasome Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject HDV-Interferon Unknown — Oral
Background Ribavirin Small molecule — —