- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Adelaide, Australia
-
Camperdown, Australia
-
Clayton, Australia
-
Darlinghurst, Australia
-
Fitzroy, Australia
-
Greenslopes, Australia
-
Melbourne, Australia
-
Perth, Australia
-
-
-
-
-
Graz N/A, Austria
-
Linz, Austria
-
Wien, Austria
-
-
-
-
-
Antwerpen, Belgium
-
Brussels, Belgium
-
Genk, Belgium
-
Gent, Belgium
-
Leuven, Belgium
-
Liege, Belgium
-
-
-
-
-
Campinas, Brazil
-
Salvador, Brazil
-
Santo Andre, Brazil
-
Sao Paulo, Brazil
-
São Paulo, Brazil
-
-
-
-
-
Clichy, France
-
Creteil, France
-
Grenoble, France
-
Lille, France
-
Lyon, France
-
Paris, France
-
Pessac, France
-
Vandoeuvre Les Nancy, France
-
Villejuif Cedex, France
-
-
-
-
-
Berlin, Germany
-
Bochum, Germany
-
Essen, Germany
-
Frankfurt, Germany
-
Hamburg, Germany
-
Kiel, Germany
-
Mainz, Germany
-
Regensburg, Germany
-
-
-
-
-
Dublin, Ireland
-
Dublin 9, Ireland
-
-
-
-
-
Mex Ctity, Mexico
-
Mexico, Mexico
-
Monterrey, Mexico
-
-
-
-
-
Bialystok, Poland
-
Bydgoszcz, Poland
-
Czeladz, Poland
-
Kielce, Poland
-
Krakow, Poland
-
Warszawa, Poland
-
-
-
-
-
Barcelona, Spain
-
Barcelona N/A, Spain
-
Madrid, Spain
-
Malaga N/A, Spain
-
Santander N/A, Spain
-
Sevilla N/A, Spain
-
Valencia, Spain
-
-
-
-
-
Göteborg, Sweden
-
Malmö, Sweden
-
Stockholm, Sweden
-
-
-
-
-
Birmingham, United Kingdom
-
Edinburgh, United Kingdom
-
Glasgow, United Kingdom
-
London, United Kingdom
-
Manchester, United Kingdom
-
-
-
-
California
-
La Jolla, California, United States
-
Los Angeles, California, United States
-
San Diego, California, United States
-
-
Colorado
-
Aurora, Colorado, United States
-
-
Connecticut
-
New Haven, Connecticut, United States
-
-
Florida
-
Bradenton, Florida, United States
-
Jacksonville, Florida, United States
-
-
Georgia
-
Atlanta, Georgia, United States
-
Marietta, Georgia, United States
-
-
Illinois
-
Chicago, Illinois, United States
-
Downers Grove, Illinois, United States
-
-
Louisiana
-
New Orleans, Louisiana, United States
-
-
Maryland
-
Lutherville, Maryland, United States
-
-
Missouri
-
Kansas City, Missouri, United States
-
-
New Hampshire
-
Lebanon, New Hampshire, United States
-
-
New Jersey
-
Egg Harbor Twp, New Jersey, United States
-
-
New Mexico
-
Santa Fe, New Mexico, United States
-
-
New York
-
New York, New York, United States
-
-
North Carolina
-
Charlotte, North Carolina, United States
-
Durham, North Carolina, United States
-
Statesville, North Carolina, United States
-
Winston Salem, North Carolina, United States
-
-
Ohio
-
Cincinnati, Ohio, United States
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States
-
Hershey, Pennsylvania, United States
-
Philadelphia, Pennsylvania, United States
-
Pittsburgh, Pennsylvania, United States
-
-
Rhode Island
-
Providence, Rhode Island, United States
-
-
South Carolina
-
Charleston, South Carolina, United States
-
Columbia, South Carolina, United States
-
-
Texas
-
Arlington, Texas, United States
-
Dallas, Texas, United States
-
Houston, Texas, United States
-
San Antonio, Texas, United States
-
-
Virginia
-
Falls Church, Virginia, United States
-
Norfolk, Virginia, United States
-
-
Washington
-
Seattle, Washington, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
|
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
|
Experimental: 002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
|
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Time Frame: End of trial, 12 weeks after last planned dose
|
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned).
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
|
End of trial, 12 weeks after last planned dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Time Frame: End of trial, 24 weeks after last planned dose
|
The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication.
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time.
Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
|
End of trial, 24 weeks after last planned dose
|
Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Time Frame: End of trial, 72 weeks after the start of study medication
|
The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned).
SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
|
End of trial, 72 weeks after the start of study medication
|
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.
Time Frame: Baseline, Week 4 and Week 4+12.
|
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
|
Baseline, Week 4 and Week 4+12.
|
Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Time Frame: Week 4, 12, 24, 32, 40
|
The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
|
Week 4, 12, 24, 32, 40
|
Percentage of Participants Who Relapsed During Follow-up Period
Time Frame: During Follow-Up (24 weeks after the last dose of study drug)
|
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
|
During Follow-Up (24 weeks after the last dose of study drug)
|
Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Time Frame: End of trial, 12 weeks after the last planned dose
|
The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
|
End of trial, 12 weeks after the last planned dose
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Virus Diseases
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- CR013711
- OPTIMIZE-HCV (Other Identifier: Janssen Infectious Diseases BVBA)
- VX-950-C211 (Other Identifier: Janssen Infectious Diseases BVBA)
- 2010-021628-84 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Genotype 1 Chronic Hepatitis C
-
Merck Sharp & Dohme LLCCompletedChronic Hepatitis C Genotype 1
-
Janssen-Cilag International NVCompletedGenotype 1 Chronic Hepatitis CRussian Federation
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
University College London HospitalsCompletedChronic Hepatitis C, HCV Genotype 1United Kingdom
-
Göteborg UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; Skane... and other collaboratorsCompletedChronic Hepatitis C, Genotype 1Sweden
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
GlobeImmuneCompleted
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States, Puerto Rico
-
R-PharmAlmedis; Scientific Center EFiS; ChromSystemsLabCompletedChronic Hepatitis c Genotype 1Russian Federation
-
Digna Biotech S.L.CompletedChronic Hepatitis C Virus Infection | Genotype 1 | Treatment-Experienced Patients | RelapsesSpain
Clinical Trials on Ribavirin
-
Institute of Liver and Biliary Sciences, IndiaTerminated
-
University of Roma La SapienzaCompleted
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Hoffmann-La RocheCompletedHealthy VolunteerMexico
-
University of BernRoche Pharma AG; University of Lausanne; University of Basel; Cantonal Hospital... and other collaboratorsCompleted
-
Janssen-Cilag International NVNo longer availableHepatitis CAustralia, Belgium, Germany, Spain, Switzerland, Romania, Serbia, Greece, New Zealand, Brazil, Russian Federation, Austria, Hungary, Czech Republic, Luxembourg
-
Conatus Pharmaceuticals Inc.Completed
-
National Institute of Diabetes and Digestive and...CompletedHepatitis C, ChronicUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
University of Colorado, DenverJanssen Scientific Affairs, LLCTerminated