Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official title:

Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00305383
• Other study ID #: RNA003142-202
• Status: Terminated
• Phase: Phase 2
• First received: March 17, 2006
• Last updated: June 21, 2012
• Start date: November 2005
• Est. completion date: May 2007

Study information

• Verified date: June 2012
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.

Description:

This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients

• Body weight greater than 61 kg and not more than 87.3 kg

• HCV RNA greater than 2 million copies/mL

• Elevated measured or historical alanine aminotransferase

• Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males

• Calculated creatinine clearance greater than 70 mL/min

Exclusion Criteria:

• Cirrhosis of the liver

• Alanine aminotransferase greater than 3 times the upper limit of normal

• Severe neuropsychiatric disorders

• History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease

• Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Viramidine

• Peginterferon alfa-2b

Locations

Country	Name	City	State
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Bach and Godofsky	Bradenton	Florida
United States	Atlantic Gastroenterology Associates	Egg Harbor Township	New Jersey
United States	Metropolitan Research -- Georgetown Medical Center	Fairfax	Virginia
United States	Maryland Digestive Disease Research	Laurel	Maryland
United States	University of Southern California -- Keck School of Medicine	Los Angeles	California
United States	University of Miami -- Center for Liver Diseases	Miami	Florida
United States	Thomas Jefferson University -- Gastroenterology and Hepatology	Philadelphia	Pennsylvania
United States	Liver Center of Long Island	Plainview	New York
United States	Mountain West Gastroenterology -- Research Office	Salt Lake City	Utah
United States	San Mateo Medical Center	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group.
Primary	Safety: Evaluation of adverse events (AEs).
Primary	Safety: Physical exams
Primary	Safety: Vital signs
Primary	Safety: Laboratory tests
Secondary	Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.