A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.
|First Received Date ICMJE||October 16, 2006|
|Last Updated Date||September 23, 2009|
|Start Date ICMJE||October 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in baseline HCV plasma RNA (i.e., viral load) at Day 11.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00389298 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||The change in plasma HCV RNA (i.e., viral load) over the treatment period (Days 1 to 10 will also be assessed.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.|
|Official Title ICMJE||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.|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Hepatitis C, Chronic|
|Intervention ICMJE||Drug: VCH-759 (BCH-27759)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||36|
|Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 60 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00389298|
|Other Study ID Numbers ICMJE||VCH759-201|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Vertex Pharmaceuticals Incorporated|
|Collaborators ICMJE||ViroChem Pharma|
|Information Provided By||Vertex Pharmaceuticals Incorporated|
|Verification Date||September 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP