Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

A Partially-blinded, Randomized, Parallel-group Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin When Administered in Combination With Pegylated Interferon Alfa-2a in Treatment-naive Patients With Chronic Hepatitis C

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00395421

Enrollment

114

Registered

2006-11-02

Start date

2006-10-31

Completion date

2008-08-31

Last updated

2010-06-10

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

Conditions

Chronic Hepatitis C

Keywords

treatment-naive

Brief summary

This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.

Interventions

DRUGNM283 plus Peg-IFNα-2a

200 mg QD 180 µg QW

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

* Documented clinical history compatible with chronic hepatitis C and compensated liver disease * Has not previously received anti-viral therapy for hepatitis C infection Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Patient is pregnant or breastfeeding * Patient is co-infected with hepatitis B virus and/or HIV Other protocol-defined

Countries

United States

Outcome results

None listed

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