NCT00389298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

First QC Date

October 16, 2006

Last Update Submit

September 23, 2009

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis CViral kineticsPhase IIPharmacokinetics (PK)Safety and tolerability

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

VCH-759 (BCH-27759)DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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)
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Foothills Medical Centre

Calgary, Alberta, T2N 4N1, Canada

Location

Liver and Intestinal Research Centre

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Ottawa Hospital; General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

McGill University Hospital Centre (MUHC) - Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

VCH-759

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marco Petrella, M.Sc., Ph.D.

    ViroChem Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 18, 2006

Study Start

October 1, 2006

Study Completion

June 1, 2007

Last Updated

September 24, 2009

Record last verified: 2009-09

Locations

CA(4)