A study to compare the safety and effectiveness of a quadruple drug regimen (VX-222, telaprevir, peginterferon alfa-2a and ribavirin) to a triple drug regimen (placebo, telaprevir, peginterferon alfa-2a and ribavirin) in treating chronic hepatitis C virus in subjects with cirrhosis who are treatment naive or nonresponders and relapsers to previous Peg-IFN/Ribavirin therapy.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2011-004150-26-GB
• Date of registration: 06/03/2012
• Prospective Registration: Yes
• Primary sponsor: Vertex Pharmaceuticals
• Public title: A study to compare the safety and effectiveness of a quadruple drug regimen (VX-222, telaprevir, peginterferon alfa-2a and ribavirin) to a triple drug regimen (placebo, telaprevir, peginterferon alfa-2a and ribavirin) in treating chronic hepatitis C virus in subjects with cirrhosis who are treatment naive or nonresponders and relapsers to previous Peg-IFN/Ribavirin therapy.
• Scientific title: A Multicenter, Randomized, Double-Blind Placebo-Controlled, Phase 2b Study to Compare the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, Ribavirin) to Triple Therapy (with VX-222-Placebo) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
• Date of first enrolment: 08/10/2012
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004150-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Germany, Poland, United Kingdom, United States

Contacts

• Name: Medical Information Center
• Affiliation: Vertex Pharmaceuticals Incorporated

• Name: Medical Information Center
• Affiliation: Vertex Pharmaceuticals Incorporated

Key inclusion & exclusion criteria

Inclusion criteria:
- Subjects (male and female, including those of childbearing potential) must be between the ages of 18 and 70 years
- Subjects must have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects must have documentation of compensated cirrhosis
- Subjects must have never received treatment for hepatitis C (treatment naive) or must not have achieved SRV24 adter at least one prior course of Peg-IFN/RBV therapy of standard duration. For subjects who have previously received treatment, the last dose of Peg-IFN/RBV must have been at least 12 weeks before the Screening Visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
-History of any illness that, in the opinion of the investigator or general practitioner might confound the results of the study or pose an additional risk to the subject
- Any contraindication to Peg-IFN or RBV therapy, or history of severe AEs while on Peg-IFN or RBV
- Evidence of hepatic decompensation
- Any other cause of significant liver disease in addition to hepatitis C
- Diagnosed or suspected hepatocellular carcinoma
- History of organ transplant, with the exception of corneal transplants and skin grafts
- A medical condition that requires frequent or prolonged use of systemic corticosteroids or immunosuppressive drugs
- History of acute pancreatitis
- History or other clinical evidence of chronic pulmonary disease associated with functional impairment
- History of other evidence of sever retinopathy or clinically significant ophthalmological disorder
- History of illicit substance or alcohol abuse within 1 year before the Screening Visit
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Chronic Hepatitis C Virus
MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: VX-222
Product Code: VX-222
Pharmaceutical Form: Tablet
CAS Number: 1026785-55-6
Current Sponsor code: VX-222
Other descriptive name: VCH-222, BCH-32222, C07062202-G
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: INCIVEK
Product Name: telaprevir
Product Code: VX-950
Pharmaceutical Form: Tablet
INN or Proposed INN: telaprevir
CAS Number: 402957-28-2
Current Sponsor code: VX-950
Other descriptive name: TELAPREVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 375-

Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: PEGINTERFERON ALFA-2A
CAS Number: 198153-51-4
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: Copegus
Product Name: Copegus
Pharmaceutical Form: Tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: To compare the safety and tolerability of the quadruple regimen to the triple regimen in subjects with compensated cirrhosis
To compare the efficacy of the quadruple regimen to the triple regimen for subjects who are treatment naive, prior relapsers, partial responders and null responders
To assess the efficacy of quadruple regimen across interleukin-28B genotypes
To characterize HCV variants in subjects who have treatment failure
To characterize the pharmacokinetics of VX-222 and telaprevir in the quadruple regimen in subjects with compensated cirrhosis

Main Objective: To compare the antiviral efficacy of a quadruple drug regimen (VX-222, telaprevir, pegylated interferon [Peg-IFN], and ribavirin [RBV]) to a triple drug regimen (placebo, telaprevir, Peg-IFN, and RBV) in subjects with genotype 1 chronic hepatitis C (CHC) with compensated cirrhosis, who are treatment naive or were nonresponders or relapsers to previous Peg-IFN/RBV therapy.

Timepoint(s) of evaluation of this end point: 12 weeks

Primary end point(s): The proportion of subjects who have an SVR (i.e., sustain an HCV RNA concentration below the lower limit of quantitation at 12 weeks after last planned dose of treatment (SVR12)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: up to 52 weeks

Secondary end point(s): -The safety and tolerability as assessed by AEs, vital signs, 12-lead electrocardiograms (ECG), and laboratory assessments (serum chemistry, hematology, and urinalysis)
- Proportion of subjects who have an SVR24 weeks after the last planned dose of the study drug (SVR24)
- Proportion of subjects who achieve undetectable HCV RNA at Weeks 2,4,8, and 12 and end of treatment
-Proportion of subjects who have on-treatment virologic failure, defined as subjects who either meet a futility rule or complete assigned treatment duration and have detectable HCV RNA at the end of study drug treatment
- Proportion of subjects who relapse at end of treatment
- The association of IL-28B genotype with SVR12
- The amino acid sequence of the NS3 and NS5B proteins in subjects who have treatment failure
- VX-222, telaprevir, RBV plasma concentrations, and Peg-IFN serum concentrations

Secondary ID(s)

VX11-222-106

2011-004150-26-DE

Source(s) of Monetary Support

Vertex Pharmaceuticals

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 07/08/2015
• Date Completed: 06/02/2014
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004150-26/results