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

This study has been completed.
Sponsor:
Collaborator:
ViroChem Pharma
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00389298
First received: October 16, 2006
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: VCH-759 (BCH-27759)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blinded, and Placebo-controlled Study of the Antiviral Activity, Safety and Pharmacokinetics of VCH-759 in Subjects With Chronic Hepatitis C-infection.

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Change in baseline HCV plasma RNA (i.e., viral load) at Day 11.

Secondary Outcome Measures:
  • The change in plasma HCV RNA (i.e., viral load) over the treatment period (Days 1 to 10 will also be assessed.

Estimated Enrollment: 36
Study Start Date: October 2006
Study Completion Date: June 2007
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 pharmacokinetic (PK) profile of VCH-759 at steady state in HCV-infected adults and the relationship between VCH-759 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-759 in adults will also be investigated. The kinetics of plasma HCV RNA during treatment for up to ten (10) days with VCH-759 and following discontinuation of therapy will also be studied.

This is a randomized, double-blinded, placebo-controlled study in which subjects will be assigned to receive treatment with one of the following oral dosages of VCH-759: 400 mg t.i.d., 600 mg t.i.d., and 800 mg t.i.d., or placebo; enrollment into the three cohorts will occur sequentially. Within each cohort, subjects will be randomized to a treatment: placebo ratio of 3:1 for a total of 12 subjects per cohort; subjects will be randomized in blocks of 4. The decision to continue dosing within a cohort will be determined by an independent review of all safety data up to and including Day 11 for the first 4 subjects within that dose cohort; this review will be conducted by a qualified medical specialist, in conjunction with the sponsor and medical monitor. The decision to proceed to the next cohort will be decided by an independent review of Day 11 safety data for all 12 subjects in the previous cohort. Eligible subjects will receive study medication three times daily for 10 days and will return to the study center for follow-up assessments on Day 11, Day 17, and Day 24.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389298

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada, V5Z 1H2
Canada, Ontario
Ottawa Hospital; General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
McGill University Hospital Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
ViroChem Pharma
Investigators
Study Director: Marco Petrella, M.Sc., Ph.D. ViroChem Pharma
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389298     History of Changes
Other Study ID Numbers: VCH759-201
Study First Received: October 16, 2006
Last Updated: September 23, 2009
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Vertex Pharmaceuticals Incorporated:
Chronic hepatitis C
Viral kinetics
Phase II
Pharmacokinetics (PK)
Safety and tolerability

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014