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

Stopped early · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00305383

Run by

Bausch Health Americas, Inc.

People needed

100

Starts

2005-11-01

Expected to finish

2007-05-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.