An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

NCT00528528 | Completed Phase 2 Results

• 3 other identifiers: CR013516VX-950-TIDP24-C2082007-001044-44
• Study Type: interventional
• Target: 166
• Locations: 6 countries
• Sites: 24

Brief Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Genotype 1; Telaprevir; Treatment-naïve; VX-950-C208; VX-950-TiDP24-C208

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Virologic Response at Week 12

  Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).

  End of treatment (EOT) (up to Week 48)

Secondary Outcomes (6)

• Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level

  Baseline (Day 1) up to EOT (up to Week 48)

• Number of Participants With Viral Breakthrough at End of Treatment (EOT)

  EOT (up to Week 48)

• Percentage of Participants With Partial Response

  Baseline (Day 1) up to EOT (up to Week 48)

• Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12

  Baseline (pre-dose), Week 12

• Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)

  Baseline (pre-dose), EOT (up to Week 48)

Study Arms (4)

Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet

EXPERIMENTAL

Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.

Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin (RBV) tablet

Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule

EXPERIMENTAL

Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.

Drug: Telaprevir; Drug: Peg-IFN-alfa-2b; Drug: Ribavirin (RBV) capsule

Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet

EXPERIMENTAL

Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.

Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin (RBV) tablet

Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule

EXPERIMENTAL

Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.

Drug: Telaprevir; Drug: Peg-IFN-alfa-2b; Drug: Ribavirin (RBV) capsule

Interventions

Telaprevir DRUG

Oval tablets containing 375 mg of telaprevir for oral administration.

Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet; Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule; Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet; Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule

Peg-IFN-alfa-2a DRUG

Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet; Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet

Peg-IFN-alfa-2b DRUG

Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule; Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule

Ribavirin (RBV) tablet DRUG

Tablets containing 200 mg RBV for oral administration.

Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet; Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet

Ribavirin (RBV) capsule DRUG

Capsules containing 200 mg RBV for oral administration.

Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule; Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule

Eligibility Criteria

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

You may qualify if:

• Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
• Never been treated for Hepatitis C Viral (HCV) infection
• No clinically significant lab abnormalities
• Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
• Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

You may not qualify if:

• Contra-indications for starting anti-HCV therapy
• History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
• Any evidence of significant liver disease in addition to Hepatitis C
• Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
• Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

Sponsors & Collaborators

• Tibotec BVBA: lead

Study Sites (24)

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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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Liège, Belgium

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Angers, France

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Clichy, France

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Grenoble, France

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Lille, France

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Nice, France

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Paris, France

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Vandœuvre-lès-Nancy, France

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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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Tübingen, Germany

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Leiden, Netherlands

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Nijmegen, Netherlands

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Barcelona, Spain

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Madrid, Spain

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Valencia, Spain

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Related Publications (1)

• Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2.

  PMID: 22387529 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

telaprevir; peginterferon alfa-2a; peginterferon alfa-2b; Ribavirin; Capsules

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; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Leader
• Organization: Janssen Research & Development, LLC Titusville, NJ

609-730-3174

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 25, 2014
• Results First Posted: May 1, 2013

Record last verified: 2014-06

Locations

AU (1); FR (7); BE (4); ES (3); NL (2); DE (7)