Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2011-004695-11-AT
• Date of registration: 02/04/2013
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb International Corporation
• Public title: Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
• Scientific title: A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered with Telaprevir in Subjects with Genotype-1 Chronic Hepatitis C who are Treatment-naïve or Relapsed on Treatment with Peginterferon Alfa and Ribavirin Revised Protocol Number: 02 - Incorporates Amendment: 3 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (dated 05-Apr-12, version 1.0)
• Date of first enrolment: 11/06/2013
• Target sample size: 629
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004695-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: EU Study Start-Up Unit
• Affiliation: Bristol-Myers Squibb International Corporation

• Name: EU Study Start-Up Unit
• Affiliation: Bristol-Myers Squibb International Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
•Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
•Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
•Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%
•HCV RNA = 100,000 IU/mL
•Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
•Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
•Men or women, 18-70 years of age

For additional inclusion criteria, please refer to Protocol section 3.3.1
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 598
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion criteria:
•Chronic liver disease due to causes other than chronic HCV
•Current or past evidence of decompensation
•Conditions that preclude the use of Alfa/RBV/TVR per respective labels
•Diagnosed or suspected hepatocellular carcinoma

For additional exclusion criteria, please refer to Protocol section 3.3.2


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

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C Virus (HCV) Infection (Genotype-1)
MedDRA version: 16.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

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

Intervention(s)

Product Name: Pegylated Interferon Lambda
Product Code: BMS-914143 / PEG-rIL-29 / PEG IFN-?1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGYLATED INTERFERON LAMBDA
Current Sponsor code: BMS-914143
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: Ribasphere
Product Name: Ribasphere
Product Code: J05AB04
Pharmaceutical Form: Tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA-2A
CAS Number: 198153-51-4
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 360-

Trade Name: Incivo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TELAPREVIR
CAS Number: 402957-28-2
Other descriptive name: TELAPREVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 375-

Primary Outcome(s)

Primary end point(s): (Please note that only part B of the study will be conducted in the EU)
Proportion of subjects achieving efficacy as measured by Sustained Virologic Response at post-treatment Week12 (SVR 12) defined as HCV RNA < LLOQ

Main Objective: The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telapravir.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: Post-treatment Week 12

Secondary Outcome(s)

Secondary end point(s): - Proportion of subjects who achieve efficacy as measured by SVR12, defined as hepatitis C virus (HCV) RNA < LLOQ in treatment-naive subjects
Time Frame: Post-treatment Week 12
- Proportion of subjects who achieve efficacy as measured by eRVR, defined as HCV RNA < LLOQ
Time Frame: On-treatment Week 4 and Week 12
- Proportion of subjects who achieve efficacy as measured by SVR 24, defined as HCV RNA < LLOQ
Time Frame: Post-treatment Week 24
- Number of incidence for Cytopenic abnormalities (anemia is defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3, thrombocytopenia as defined by platelets < 50,000 mm3)
Time Frame: Up to 48 weeks
- Number of incidence for Flu-like symptoms (as defined by pyrexia or chills or pain)
Time Frame: Up to 48 weeks
- Number of incidence for Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Time Frame: Up to 48 weeks

Timepoint(s) of evaluation of this end point: See section E.5.2

Secondary ID(s)

AI452-020

NCT01598090

Source(s) of Monetary Support

Bristol-Myers Squibb International Corporation