Clinical trial NCT01241760: VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Official title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genotype 1 Chronic Hepatitis C
Treatment Naive
Keywords: Genotype 1 chronic hepatitis C
VX-950-C211
VX-950
IL28B
Telaprevir
Hepatitis C
BID
Q8h
SOC
Lead sponsor: Janssen Infectious Diseases BVBA
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2010-11-16
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Detailed description: This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Eligibility criteria: Inclusion Criteria:

* Patient has chronic HCV infection genotype 1 with HCV RNA level \> 1,000 IU/mL
* Patients should not have had any previous treatment for hepatitis C
* Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
* Patients with cirrhosis should have serum alpha-fetoprotein (AFP) \<= 50 ng/mL. If AFP \> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

* Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
* Patient has a pre-existing psychiatric condition
* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
timeFrame: End of trial, 12 weeks after last planned dose
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
timeFrame: End of trial, 24 weeks after last planned dose
measure: Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
timeFrame: End of trial, 72 weeks after the start of study medication
measure: Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
timeFrame: Baseline, Week 4 and Week 4+12.
measure: Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
timeFrame: Week 4, 12, 24, 32, 40
measure: Percentage of Participants Who Relapsed During Follow-up Period
timeFrame: During Follow-Up (24 weeks after the last dose of study drug)
measure: Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
timeFrame: End of trial, 12 weeks after the last planned dose
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Downers Grove
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Lutherville
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Egg Harbor Twp
country: United States
state: New Jersey
city: Santa Fe
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Adelaide
country: Australia
city: Camperdown
country: Australia
city: Clayton
country: Australia
city: Darlinghurst
country: Australia
city: Fitzroy
country: Australia
city: Greenslopes
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Graz N/A
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Campinas
country: Brazil
city: Salvador
country: Brazil
city: Santo Andre
country: Brazil
city: Sao Paulo
country: Brazil
city: São Paulo
country: Brazil
city: Clichy
country: France
city: Creteil
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Lyon
country: France
city: Paris
country: France
city: Pessac
country: France
city: Vandoeuvre Les Nancy
country: France
city: Villejuif Cedex
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Mainz
country: Germany
city: Regensburg
country: Germany
city: Dublin 9
country: Ireland
city: Dublin
country: Ireland
city: Mex Ctity
country: Mexico
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Czeladz
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Barcelona N/A
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga N/A
country: Spain
city: Santander N/A
country: Spain
city: Sevilla N/A
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Birmingham
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Janssen Infectious Diseases BVBA
name: Janssen Infectious Diseases BVBA Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
citation: Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.