Clinical trial NCT00305383: Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
Official title: Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Viramidine
Peginterferon alfa-2b
Valeant
Hepatitis C
Rapid virologic response
HCV RNA
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
measure: Safety: Evaluation of adverse events (AEs).
measure: Safety: Physical exams
measure: Safety: Vital signs
measure: Safety: Laboratory tests
Secondary outcomes:
measure: Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California -- Keck School of Medicine
state: California
city: San Mateo
country: United States
facility: San Mateo Medical Center
state: California
city: Bradenton
country: United States
facility: Bach and Godofsky
state: Florida
city: Miami
country: United States
facility: University of Miami -- Center for Liver Diseases
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Egg Harbor Township
country: United States
facility: Atlantic Gastroenterology Associates
state: New Jersey
city: Plainview
country: United States
facility: Liver Center of Long Island
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University -- Gastroenterology and Hepatology
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Mountain West Gastroenterology -- Research Office
state: Utah
city: Fairfax
country: United States
facility: Metropolitan Research -- Georgetown Medical Center
state: Virginia
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Ralph T. Doyle
role: STUDY_DIRECTOR
References: