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Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

NCT00971308•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
•HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL)
•Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion Criteria

•Women who are pregnant or breast feeding
•Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
•Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study

Locations (6)

Advanced Clinical Research Institute

Anaheim, California, United States

West Coast Clinical Trials, Llc

Cypress, California, United States

Elite Research Institute

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Parexel International - Baltimore Epcu

Baltimore, Maryland, United States

Alamo Medical Research

San Antonio, Texas, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

January 25, 2011

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

BMS-824393

DRUG

BMS-824393

DRUG

BMS-824393

DRUG

BMS-824393

DRUG

BMS-824393

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

View study

COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

View study

COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection