A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

NCT00703118 | Completed Phase 3 Results DMC

• 2 other identifiers: CR014842VX-950-TIDP24-C216
• Study Type: interventional
• Target: 663
• Locations: 15 countries
• Sites: 89

Brief Summary

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; Telaprevir; Peg-IFN-alfa-2a; Ribavirin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned

  SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.

  Week 72

Secondary Outcomes (7)

• Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4

  Week 4

• Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)

  Week 48

• Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned

  Week 60

• Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8

  Week 4, Week 6, or Week 8

• Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)

  Up to Week 72

Study Arms (3)

Group A: T12/PR48

EXPERIMENTAL

Participants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.

Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin; Drug: Placebo

Group B: T12(DS)/PR48

EXPERIMENTAL

Participants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.

Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin; Drug: Placebo

Group C: Pbo/PR48

EXPERIMENTAL

Participants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks. Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.

Drug: Peg-IFN-alfa-2a; Drug: Ribavirin; Drug: Placebo

Interventions

Telaprevir DRUG

Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

Group A: T12/PR48; Group B: T12(DS)/PR48

Peg-IFN-alfa-2a DRUG

Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

Group A: T12/PR48; Group B: T12(DS)/PR48; Group C: Pbo/PR48

Ribavirin DRUG

Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

Group A: T12/PR48; Group B: T12(DS)/PR48; Group C: Pbo/PR48

Placebo DRUG

Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.

Group A: T12/PR48; Group B: T12(DS)/PR48; Group C: Pbo/PR48

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level \>= 1000 IU/mL
• Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
• Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

You may not qualify if:

• Patient is a previous non-responder that is classified as a viral breakthrough case
• Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
• Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
• Evidence of decompensated liver disease
• Patient has condition that requires use of systemic corticosteroids

Sponsors & Collaborators

• Tibotec BVBA: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (91)

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Birmingham, Alabama, United States

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Coronado, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Bradenton, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Plymouth, Minnesota, United States

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Kansas City, Missouri, United States

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Egg Harbor Twp, New Jersey, United States

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Albuquerque, New Mexico, United States

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Manhasset, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Adelaide, Australia

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Camperdown, Australia

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Clayton, Australia

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Darlinghurst, Australia

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Kingswood, Australia

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Melbourne, Australia

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Parkville - Vic, Australia

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Perth, Australia

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Graz, Austria

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Vienna, Austria

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Distrito Barao Geraldo-Campina, Brazil

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Salvador, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Clichy, France

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Créteil, France

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Grenoble, France

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Lille, France

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Lyon, France

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Marseille, France

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Paris, France

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Pessac, France

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Vandœuvre-lès-Nancy, France

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Berlin, 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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Petah Tikva, Israel

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Safed, Israel

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Tel Aviv, Israel

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Amsterdam-Zuidoost, Netherlands

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Leiden, Netherlands

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Nijmegen, Netherlands

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Bialystok, Poland

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Czeladź, Poland

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Kielce, Poland

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Lodz, Poland

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Warsaw, Poland

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Santurce, Puerto Rico

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Barcelona, Spain

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Madrid, Spain

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Seville, Spain

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Valencia, Spain

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Stockholm, Sweden

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Sankt Gallen, Switzerland

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Zurich, Switzerland

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Birmingham, United Kingdom

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London, United Kingdom

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Related Publications (4)

• Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.

  PMID: 24486089 DERIVED

• Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.

  PMID: 24382638 DERIVED

• Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.

  PMID: 23321318 DERIVED

• Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

  PMID: 21696308 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

telaprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Leader
• Organization: Tibotec

1 609 730-3174

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

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: June 19, 2008
• First Posted: June 23, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 22, 2014
• Results First Posted: August 11, 2011

Record last verified: 2013-12

Locations

GB (2); BE (3); DE (8); FR (9); CH (2); BR (4); AU (8); PL (5); ES (4); IL (5); PR (1); SE (1); US (31); NL (3); CA (3)