HCV Infection Clinical Trial
Official title:
A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Royal Victoria Hospital | Montréal | Quebec |
Canada | Ottawa Hospital - General Campus | Ottawa | Ontario |
Puerto Rico | Fundacion de Investigacion de Diego | Santurce | |
United States | The Liver INstitute at Methodist Dallas | Dallas | Texas |
United States | Alamo Medical Research | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Vertex Pharmaceuticals Incorporated | Duke Clinical Research Institute, ViroChem Pharma |
United States, Canada, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection. | Day 1 to Day 17 visits | Yes | |
Secondary | To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults. | Day 1 visit | No | |
Secondary | To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults. | Day 1 to Day 4 visits | No | |
Secondary | To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916. | Day 1 to Day 4 visits | No |
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