A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
1 other identifier
interventional
1,095
12 countries
114
Brief Summary
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2008
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
July 21, 2011
CompletedAugust 8, 2014
July 1, 2014
2.2 years
February 22, 2008
June 22, 2011
July 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
24 weeks after last planned dose of study treatment (up to Week 72)
Secondary Outcomes (12)
Number of Subjects With Undetectable HCV RNA at Week 72
Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Week 4
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Week 4 and Week 12
Number of Subjects With Undetectable HCV RNA at Week 12
Week 12
Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
End of treatment (up to Week 48)
- +7 more secondary outcomes
Study Arms (3)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
PLACEBO COMPARATORPlacebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
EXPERIMENTALTelaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
EXPERIMENTALTelaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Interventions
subcutaneous injection, 180 micrograms once per week
375 mg tablets administered orally every 8 hours at a dose of 750 mg
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg
Telaprevir matching placebo
Eligibility Criteria
You may qualify if:
- Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Male and female subjects, 18 to 70 years of age, inclusive
- Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
- Screening laboratory values, tests, and physical exam within acceptable ranges
- Able and willing to follow contraception requirements
- Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions
You may not qualify if:
- Subject has any contraindications to Pegasys® or Copegus® therapy
- Evidence of hepatic decompensation in cirrhotic subjects
- History of organ transplant
- History of, or any current medical condition which could impact the safety of the subject in participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
Unknown Facility
Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35294, United States
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Phoenix, Arizona, 85054, United States
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Fresno, California, 93721, United States
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La Jolla, California, 92037, United States
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Long Beach, California, 90822, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90048, United States
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San Diego, California, 92103, United States
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San Diego, California, 92123, United States
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San Diego, California, 92154, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94121, United States
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San Francisco, California, 94143, United States
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Aurora, Colorado, 80045, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32224, United States
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Jacksonville, Florida, 32256, United States
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Miami, Florida, 33136, United States
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Orlando, Florida, 32803, United States
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Sarasota, Florida, 34243, United States
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South Miami, Florida, 33143, United States
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Atlanta, Georgia, 30308, United States
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Savannah, Georgia, 31405, United States
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Honolulu, Hawaii, 96817, United States
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Chicago, Illinois, 60637, United States
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Carmel, Indiana, 46032, United States
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Indianapolis, Indiana, 46202, United States
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Portland, Maine, 04102, United States
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Baltimore, Maryland, 21287, United States
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Laurel, Maryland, 20707, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Kansas City, Missouri, 64131, United States
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St Louis, Missouri, 63104, United States
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Omaha, Nebraska, 68105, United States
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Albuquerque, New Mexico, 87131, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10003, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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Valhalla, New York, 10595, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28203, United States
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Durham, North Carolina, 27710, United States
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Fayetteville, North Carolina, 28304, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44195, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Columbia, South Carolina, 29204, United States
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Germantown, Tennessee, 38138, United States
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Dallas, Texas, 75203, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78215, United States
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Annandale, Virginia, 22003, United States
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Charlottesville, Virginia, 22908, United States
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Richmond, Virginia, 23249, United States
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Buenos Aires, Argentina
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Darlinghurst, Australia
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Fitzroy, Australia
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Greenslopes, Australia
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Melbourne, Australia
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Perth, Australia
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Westmead, Australia
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Woolloongabba, Australia
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Linz, Austria
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Vienna, Austria
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Calgary, Canada
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Toronto, Canada
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Vancouver, Canada
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Winnipeg, Canada
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Clichy, France
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Créteil, France
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Grenoble, France
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Lyon, France
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Nice, France
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Paris, France
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Pessac, France
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Toulouse, France
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Berlin, Germany
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Bochum, Germany
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Cologne, Germany
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Düsseldorf, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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München, Germany
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Haifa, Israel
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Jerusalem, Israel
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Nazareth, Israel
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Petah Tikva, Israel
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Tel Litwinsky, Israel
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Bologna, Italy
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Milan, Italy
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Torino, Italy
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Bialystok, Poland
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Czeladź, Poland
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Kielce, Poland
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Krakow, Poland
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Lodz, Poland
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Wroclaw, Poland
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Santurce, 00909, Puerto Rico
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Barcelona, Spain
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Valencia, Spain
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Glasgow, United Kingdom
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Hampstead, United Kingdom
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London, United Kingdom
Related Publications (1)
Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.
PMID: 21696307DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Chodakewitz, M.D.
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2008
First Posted
March 4, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 8, 2014
Results First Posted
July 21, 2011
Record last verified: 2014-07