A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00118768

Enrollment

175

Registered

2005-07-12

Start date

2005-08-31

Completion date

Unknown

Last updated

2009-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Genotype-1, Chronic Hepatitis C

Brief summary

This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).

Interventions

DRUGvalopicitabine

DRUGPegylated Interferon Alfa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

* Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease * Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection) * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Patient is pregnant or breastfeeding * Patient is co-infected with HIV or Hepatitis B * Other protocol-defined

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026