Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection

Hepatitis C Clinical Trial

Official title:

A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911963
• Other study ID #: VCH-222-102
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 29, 2009
• Last updated: February 6, 2014
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaArgentina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin.

The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)

• Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)

• Plasma HCV RNA of 100,000 IU/ml

• HIV 1 and HIV2 ab seronegative

• Body Mass Index (BMI) = 35 kg/m2 BMI

• Treatment Naive subjects

Exclusion Criteria:

• Contraindications to peginterferon or ribavirin therapy

• Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score > 5

• Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• VCH-222 or matching placebo
capsule, oral, 4 doses once daily or twice daily, 3 days
• VCH-222 or matching placebo
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks

Biological:
• peginterferon alfa-2a
subcutaneous injection, 180 µg, once weekly, 48 weeks

Drug:
• ribavirin
tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks

Locations

Country	Name	City	State
Argentina	ACLIRES Argentina SRL	Buenos Aires
Argentina	Hospital Universitario Austral	Buenos Aires
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Downtown ID Clinic/University of British Columbia	Vancouver	British Columbia
Canada	John Buhler Research Centre	Winnipeg	Manitoba
Puerto Rico	Fundacion de Investigation de Diego	Santurce
United States	The liver institute at Methodist hospital	Dallas	Texas
United States	Henry Ford Health Sytem	Detroit	Michigan
United States	Gastrointestinal Specialists of Georgia PC	Marietta	Georgia
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	ViroChem Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)		Daily for the first 3 days and at each study visit	Yes
Primary	To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)		Week 4 and Week 12	Yes
Primary	Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)		Study visits throughout part B	Yes
Secondary	To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)		Study visits throughout Part A	Yes
Secondary	To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)		Time points through Part B	No