Back to resultsPharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VCH-222 or matching placebo
VCH-222 or matching placebo
peginterferon alfa-2a
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring VX-222
Eligibility 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
Sites / Locations
- Gastrointestinal Specialists of Georgia PC
- Henry Ford Health Sytem
- The liver institute at Methodist hospital
- Alamo Medical Research
- ACLIRES Argentina SRL
- Hospital Universitario Austral
- Downtown ID Clinic/University of British Columbia
- John Buhler Research Centre
- Ottawa Hospital
- Fundacion de Investigation de Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A
Part B
Arm Description
This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.
VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks
Outcomes
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)
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)
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Secondary Outcome Measures
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Full Information
NCT ID
NCT00911963
First Posted
May 29, 2009
Last Updated
February 6, 2014
Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
ViroChem Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00911963
Brief Title
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
VX-222
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A
Arm Type
Experimental
Arm Description
This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.
Arm Title
Part B
Arm Type
Experimental
Arm Description
VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks
Intervention Type
Drug
Intervention Name(s)
VCH-222 or matching placebo
Other Intervention Name(s)
VCH-222 is also known as VX-222
Intervention Description
capsule, oral, 4 doses once daily or twice daily, 3 days
Intervention Type
Drug
Intervention Name(s)
VCH-222 or matching placebo
Other Intervention Name(s)
VCH-222 is also known as VX-222
Intervention Description
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
Intervention Type
Biological
Intervention Name(s)
peginterferon alfa-2a
Intervention Description
subcutaneous injection, 180 μg, once weekly, 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Time Frame
Time points through Part B
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Gastrointestinal Specialists of Georgia PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Henry Ford Health Sytem
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
The liver institute at Methodist hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
ACLIRES Argentina SRL
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Buenos Aires
Country
Argentina
Facility Name
Downtown ID Clinic/University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
John Buhler Research Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Fundacion de Investigation de Diego
City
Santurce
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
24982088
Citation
Jiang M, Zhang EZ, Ardzinski A, Tigges A, Davis A, Sullivan JC, Nelson M, Spanks J, Dorrian J, Nicolas O, Bartels DJ, Rao BG, Rijnbrand R, Kieffer TL. Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor. Antimicrob Agents Chemother. 2014 Sep;58(9):5456-65. doi: 10.1128/AAC.03052-14. Epub 2014 Jun 30.
Results Reference
derived
Learn more about this trial
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
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