Status:
COMPLETED
A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
ViroChem Pharma
Conditions:
Hepatitis C, Chronic
Eligibility:
MALE
18-60 years
Phase:
PHASE1
PHASE2
Brief 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 c...
Detailed Description
The primary objectives of this trial are to assess the antiviral activity, safety, and tolerability of VCH-759 monotherapy in adult subjects with early-stage chronic HCV-infection. In addition, the p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00389298
Start Date
October 1 2006
End Date
June 1 2007
Last Update
September 24 2009
Active Locations (4)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4N1
2
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada, V5Z 1H2
3
Ottawa Hospital; General Campus
Ottawa, Ontario, Canada, K1H 8L6
4
McGill University Hospital Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1