Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection

Completed · Phase 1 · Has a placebo group

Conditions studied: HCV Infection

In brief

The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.

Key facts

Study ID

NCT00623649

Run by

Vertex Pharmaceuticals Incorporated

People needed

42

Starts

2007-11-01

Expected to finish

2008-10-01

Last updated by the study team

2014-04-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females 18 to 60 years of age
• No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
• Subject's liver disease is stable with ALT values < 5 X ULN
• Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening
• Documented HCV Genotype 1 chronic hepatitis C.
• Judged to be in good health on the basis of medical history and physical examination
• All other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities.
• Be treatment-naïve or experienced.
• For female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control.
• Sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period
• Female subjects of childbearing potential must have a negative serum ß-HCG pregnancy test at screening and a negative urine pregnancy test on Day 1 before the first dose of study drugs.
• Agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial.

You may not qualify if…

• Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
• Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol.
• Have a Child-Pugh score > than 5.
• Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy.
• Have any cause of liver disease other than chronic hepatitis C-infection
• Active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
• Have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months
• Have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia.
• Have a history of psychiatric disorders determined by the investigator to contraindicate therapy.
• Have uncontrolled Type 1 or Type II diabetes.
• Antinuclear antibody titer ≥1:320.
• Coinfection with hepatitis B and/or HIV 1 or HIV 2.

Where it is running

• The Liver INstitute at Methodist Dallas — Dallas, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico

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.