A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether a 10-day course of therapy with orally administered VCH-759 given at 400-mg, 600-mg or 800-mg three times daily 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-759. Blood samples will also be taken to measure the levels of VCH-759 present in plasma at various time points during the treatment period.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborator: ViroChem Pharma

Criteria

Inclusion Criteria:

• 18 to 60 years of age

• Body mass index (BMI) ≤ 30

• No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3

• Subject's liver disease is stable (i.e., stable ALT and AST)

• Serologic evidence of chronic hepatitis C-infection (anti-HCV in serum)

• HCV plasma RNA >1 x 105 (copies/mL) at baseline

• HCV Genotype 1

• Documented liver biopsy within the last 5 years

• Hemoglobin > or =11.0 g/dL for females and > or =12.0 g/dL for males

• Platelet count higher than 50

• Treatment-naïve for HCV-infection

• Normal calculated creatinine clearance using the Modification of Diet in Renal Disease (MDRD) study formula

• Normal thyroid function

• Female subjects, cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control

• Sexually active male subjects, must be practicing acceptable methods of contraception (vasectomy, use of condom plus spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period

• Negative serum ß-HCG (females only)

• Provided informed consent

• Willing to comply with all study requirements

Exclusion Criteria:

• Participating in any other clinical studies or have participated in another clinical trial within the last 30 days

• Have relapsed following previous therapy for hepatitis C-infection

• Actively taking hard illicit drugs (such as cocaine, phencyclidine, or crack within 6 months before screening visit)

• Evidence of liver cirrhosis

• Child-Pugh score >5

• Any cause of liver disease other than chronic hepatitis C-infection, including but not limited to:

• Hemochromatosis

• Alpha-1 antitrypsin deficiency

• Wilson's disease

• Autoimmune hepatitis

• Autoimmune thyroidopathy

• Alcoholic liver disease

• Nonalcoholic steatohepatitis

• Drug-related liver disease

• Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)

• Organ transplants, except for corneal or hair transplant

• Clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia, or prolongation of QTc interval)

• Significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia

• Type 1 diabetes, or Type II diabetes being treated with oral hypoglycemic agents

• Co-infection with hepatitis B (HBV) and/or human immunodeficiency (HIV) virus

• Taking the following concomitant medications:

• Drugs of abuse (as outlined above)

• Systemic antibiotic, antiviral, or antifungal treatments

• All cytostatic or oncolytic medications

• Drugs that are under routine therapeutic drug monitoring such as antiepileptic (anti-seizure) drugs, digoxin, coumadin and others

• All lipid lowering agents

• Drugs that influence hemostasis

• Thyreostatic drugs from the group of thionamids

• The following antihistaminics: terfenadine, cyproheptadine and promethazine

• Tricyclic antidepressants

• Antipsychotic drugs (neuroleptics)

• Lithium

• Thalidomide

• Other condition that, in the investigator's opinion, could determine that the subject's participation in the study is not indicated or could interfere with the subject's participation in and completion of study

• Randomized to this study more than once