Overview

A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

Status:
Completed

Trial end date:
2012-06-01

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

HanAll BioPharma Co., Ltd.

Treatments:

Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin