Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

NCT01459913 | Terminated Phase 3 Results

• 1 other identifier: VX11-950-114
• Study Type: interventional
• Target: 239
• Locations: 6 countries
• Sites: 83

Brief Summary

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

Conditions

Hepatitis C, Chronic

Keywords

VX-950; INCIVEK; INCIVO

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

  SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. 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. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

  12 weeks after last planned dose of study drug (up to Week 36)

Secondary Outcomes (8)

• Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)

  4 weeks after last planned dose of study drug (up to Week 28)

• Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

  24 weeks after last planned dose of study drug (up to Week 48)

• Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)

  Week 72

• Percentage of Subjects With Viral Relapse

  After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up

• Percentage of Subjects With On-Treatment Virologic Failure

  Baseline up to Week 48

Study Arms (4)

Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)

EXPERIMENTAL

Telaprevir 1125 milligram (mg) tablet twice 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 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus \[HCV\] Ribonucleic Acid \[RNA\] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.

Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)

EXPERIMENTAL

Telaprevir 1125 mg tablet twice 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 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)

EXPERIMENTAL

Telaprevir 1125 mg tablet twice 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 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.

Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)

EXPERIMENTAL

Telaprevir 1125 mg tablet twice 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 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.

Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Interventions

Telaprevir DRUG

Tablet

Also known as: INCIVEK, INCIVO, VX-950

Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized); Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized); Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized); Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)

Pegylated Interferon Alfa-2a DRUG

Subcutaneous Injection

Also known as: Pegasys, Peg-IFN-Alfa-2a

Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized); Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized); Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized); Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)

Ribavirin DRUG

Tablet

Also known as: Copegus, RBV

Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized); Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized); Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized); Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)

Eligibility Criteria

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

You may qualify if:

• Male and female subjects, 18 to 70 years of age, inclusive
• Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
• Subjects have IL28B CC genotype determined during screening
• Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required

You may not qualify if:

• Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
• Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
• Subjects have evidence of hepatic decompensation
• Subjects have evidence of cirrhosis
• Subjects have diagnosed or suspected hepatocellular carcinoma
• Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (83)

Unknown Facility

Birmingham, Alabama, 35209, United States

Location

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Phoenix, Arizona, 85054, United States

Location

Unknown Facility

La Jolla, California, 93037, United States

Location

Unknown Facility

Los Angeles, California, 90027, United States

Location

California

Los Angeles, California, 90048, United States

Location

Unknown Facility

Sacramento, California, 95817, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

San Diego, California, 92105, United States

Location

Unknown Facility

San Diego, California, 92154, United States

Location

California

San Francisco, California, 94115, United States

Location

Unknown Facility

Farmington, Connecticut, 06030, United States

Location

Unknown Facility

New Haven, Connecticut, 06511, United States

Location

Unknown Facility

Bradenton, Florida, 34209, United States

Location

Unknown Facility

Gainesville, Florida, 32224, United States

Location

Unknown Facility

Jacksonville, Florida, 32224, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Marietta, Georgia, 30060, United States

Location

Unknown Facility

Honolulu, Hawaii, 96817, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Baltimore, Maryland, 21202, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Columbia, Maryland, 21045, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Brockton, Massachusetts, 02302, United States

Location

Unknown Facility

Burlington, Massachusetts, 01805, United States

Location

Unknown Facility

Worcester, Massachusetts, 01605, United States

Location

Unknown Facility

Novi, Michigan, 48202, United States

Location

Unknown Facility

Kansas City, Missouri, 64131, United States

Location

Unknown Facility

Lebanon, New Hampshire, 03756, United States

Location

Unknown Facility

Egg Harbor, New Jersey, 08234, United States

Location

Unknown Facility

Vineland, New Jersey, 08360, United States

Location

Unknown Facility

Flushing, New York, 11355, United States

Location

Unknown Facility

Manhasset, New York, 10030, United States

Location

Unknown Facility

New York, New York, 10003, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27599, United States

Location

Unknown Facility

Charlotte, North Carolina, 28203, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Pennsylvania

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Arlington, Texas, 76012, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

Virginia

Fairfax, Virginia, 22031, United States

Location

Unknown Facility

Falls Church, Virginia, 22042, United States

Location

Unknown Facility

Norfolk, Virginia, 23502, United States

Location

Unknown Facility

Richmond, Virginia, 23249, United States

Location

Unknown Facility

Seattle, Washington, 98101, United States

Location

Unknown Facility

Madison, Wisconsin, 53715, United States

Location

Unknown Facility

Madison, Wisconsin, 53792, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

Unknown Facility

Linz, 4010, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Vienna, 1160, Austria

Location

Unknown Facility

Calgary, Alberta, T2N 4Z6, Canada

Location

Unknown Facility

Edmonton, Alberta, T5M 1J7, Canada

Location

Unknown Facility

Edmonton, Alberta, T6G 2X8, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2N2, Canada

Location

Unknown Facility

Toronto, Ontario, M5T 2S8, Canada

Location

Unknown Facility

Berlin, 10969, Germany

Location

Unknown Facility

Cologne, 50937, Germany

Location

Unknown Facility

Düsseldorf, 40237, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Hamburg, 20099, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Leipzig, 4103, Germany

Location

Unknown Facility

Munich, 81377, Germany

Location

Unknown Facility

Haifa, 31096, Israel

Location

Unknown Facility

Haifa, 34362, Israel

Location

Israel

Jerusalem, 91120, Israel

Location

Unknown Facility

Nazareth, 16100, Israel

Location

Unknown Facility

Petah Tikva, 49100, Israel

Location

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

Unknown Facility

Bialystok, 16-540, Poland

Location

Unknown Facility

Czeladź, 41-250, Poland

Location

Unknown Facility

Mysłowice, 41-400, Poland

Location

Unknown Facility

Wroclaw, 50-220, Poland

Location

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

Limitations and Caveats

The study was terminated early at the primary efficacy endpoint (SVR12), by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Study Officials

• Mark Friedman, M.D.

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-05

Locations

CA (7); AU (3); IL (6); US (55); DE (8); PL (4)