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

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: VCH-222 or matching placebo Biological: peginterferon alfa-2a Drug: ribavirin	Phase 1 Phase 2

Study Type:	Interventional
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
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

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) [ Time Frame: Daily for the first 3 days and at each study visit ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B) [ Time Frame: Study visits throughout part B ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A) [ Time Frame: Study visits throughout Part A ] [ Designated as safety issue: Yes ]
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B) [ Time Frame: Time points through Part B ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	April 2009
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part A This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.	Drug: VCH-222 or matching placebo capsule, oral, 4 doses once daily or twice daily, 3 days Other Name: VCH-222 is also known as VX-222
Experimental: Part B VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks	Drug: VCH-222 or matching placebo capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks Other Name: VCH-222 is also known as VX-222 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911963

Locations

United States, Georgia
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States, 30060
United States, Michigan
Henry Ford Health Sytem
Detroit, Michigan, United States, 48202
United States, Texas
The liver institute at Methodist hospital
Dallas, Texas, United States, 75203
Alamo Medical Research
San Antonio, Texas, United States, 78215
Argentina
ACLIRES Argentina SRL
Buenos Aires, Argentina
Hospital Universitario Austral
Buenos Aires, Argentina
Canada, British Columbia
Downtown ID Clinic/University of British Columbia
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Manitoba
John Buhler Research Centre
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Puerto Rico
Fundacion de Investigation de Diego
Santurce, Puerto Rico

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

ViroChem Pharma

Investigators

Study Director:

Medical Monitor

Vertex Pharmaceuticals Incorporated

More Information

No publications provided

Responsible Party:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00911963 History of Changes
Other Study ID Numbers:	VCH-222-102
Study First Received:	May 29, 2009
Last Updated:	October 8, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Argentina: Ministry of Health

Keywords provided by Vertex Pharmaceuticals Incorporated:

VX-222

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013