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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
VCH-759 (BCH-27759)
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Chronic hepatitis C, Viral kinetics, Phase II, Pharmacokinetics (PK), Safety and tolerability

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Foothills Medical Centre
  • Liver and Intestinal Research Centre
  • Ottawa Hospital; General Campus
  • McGill University Hospital Centre (MUHC) - Royal Victoria Hospital

Outcomes

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.

Full Information

First Posted
October 16, 2006
Last Updated
September 23, 2009
Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
ViroChem Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00389298
Brief Title
A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
ViroChem Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Chronic hepatitis C, Viral kinetics, Phase II, Pharmacokinetics (PK), Safety and tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VCH-759 (BCH-27759)
Primary Outcome Measure Information:
Title
Change in baseline HCV plasma RNA (i.e., viral load) at Day 11.
Secondary Outcome Measure Information:
Title
The change in plasma HCV RNA (i.e., viral load) over the treatment period (Days 1 to 10 will also be assessed.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Petrella, M.Sc., Ph.D.
Organizational Affiliation
ViroChem Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Liver and Intestinal Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Ottawa Hospital; General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
McGill University Hospital Centre (MUHC) - Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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