Study Stopped
Dose levels were determined to be subtherapeutic
Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C
1 other identifier
interventional
100
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2005
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 17, 2006
CompletedFirst Posted
Study publicly available on registry
March 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 22, 2012
June 1, 2012
March 17, 2006
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Safety: Evaluation of adverse events (AEs).
Safety: Physical exams
Safety: Vital signs
Safety: Laboratory tests
Secondary Outcomes (1)
Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Southern California -- Keck School of Medicine
Los Angeles, California, 90033, United States
San Mateo Medical Center
San Mateo, California, 94403, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
University of Miami -- Center for Liver Diseases
Miami, Florida, 33136, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Maryland Digestive Disease Research
Laurel, Maryland, 20707, United States
Atlantic Gastroenterology Associates
Egg Harbor, New Jersey, 08234, United States
Liver Center of Long Island
Plainview, New York, 11803, United States
Thomas Jefferson University -- Gastroenterology and Hepatology
Philadelphia, Pennsylvania, 19107, United States
Mountain West Gastroenterology -- Research Office
Salt Lake City, Utah, 84121, United States
Metropolitan Research -- Georgetown Medical Center
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ralph T. Doyle
Bausch Health Americas, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2006
First Posted
March 21, 2006
Study Start
November 1, 2005
Study Completion
May 1, 2007
Last Updated
June 22, 2012
Record last verified: 2012-06