An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

NCT01467505 | Terminated Phase 2 Results

• 1 other identifier: VX11-950-117
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 22

Brief Summary

To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants 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 (\<lower limit of quantification) at 12 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).

  12 weeks after last planned dose of study drug (up to Week 60)

Secondary Outcomes (11)

• Percentage of Participants 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 72)

• Percentage of Participants With Rapid Viral Response (RVR)

  Week 4

• Percentage of Participants With Extended Rapid Viral Response (eRVR)

  Week 4 and Week 12

• Percentage of Participants With On-Treatment Virologic Failure

  Baseline up to Week 48

• Percentage of Participants With Viral Relapse

  48 weeks

Other Outcomes (1)

• Percentage of Participants 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 52)

Study Arms (2)

T/PR + Immunosuppressant Regimen (Tacrolimus)

EXPERIMENTAL

Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (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. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.

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

T/PR + Immunosuppressant Regimen (Cyclosporine)

EXPERIMENTAL

Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received 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. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.

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

Interventions

Telaprevir DRUG

Tablet

Also known as: VX-950

T/PR + Immunosuppressant Regimen (Cyclosporine); T/PR + Immunosuppressant Regimen (Tacrolimus)

Ribavirin DRUG

Tablet

Also known as: Copegus®, RBV

T/PR + Immunosuppressant Regimen (Cyclosporine); T/PR + Immunosuppressant Regimen (Tacrolimus)

Pegylated Interferon Alfa-2a DRUG

Subcutaneous Injection

Also known as: Pegasys®, Peg-IFN-alfa-2a

T/PR + Immunosuppressant Regimen (Cyclosporine); T/PR + Immunosuppressant Regimen (Tacrolimus)

Immunosuppressant Regimen DRUG

Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.

T/PR + Immunosuppressant Regimen (Cyclosporine); T/PR + Immunosuppressant Regimen (Tacrolimus)

Eligibility Criteria

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

You may qualify if:

• Male and female participants between the ages of 18 and 65 years
• History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
• Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
• Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response

You may not qualify if:

• Documented cirrhosis after liver transplantation
• Ascites or hepatic encephalopathy within 6 months before Screening
• Retransplantation for recurrent hepatitis C
• Treatment for hepatitis C post liver transplantation
• History within the past 3 months of: rejection within 3 months or greater than (\>) 1 rejection within 12 months
• Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (\<5 milligram per day) is permitted
• History within 3 months of any bacterial infection requiring \>1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
• History of post transplant lymphoproliferative disease
• Acceptable laboratory values at Screening as specified in the protocol
• Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen
• History of hepatocellular carcinoma with high risk of recurrence
• Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
• Autoimmune-mediated disease
• History of acute pancreatitis within 5 years before the Screening visit
• Prior treatment with an hepatitis C virus (HCV) protease inhibitor

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (22)

Alabama

Birmingham, Alabama, United States

Location

Arizona

Phoenix, Arizona, United States

Location

California

Los Angeles, California, United States

Location

Colorado

Denver, Colorado, United States

Location

Florida

Bradenton, Florida, United States

Location

Florida

Miami, Florida, United States

Location

Illinios

Evanston, Illinois, United States

Location

Indiana

Indianapolis, Indiana, United States

Location

Massachusetts

Burlington, Massachusetts, United States

Location

Michigan

Ann Arbor, Michigan, United States

Location

Michigan

Detroit, Michigan, United States

Location

Missouri

St Louis, Missouri, United States

Location

Nebraska

Omaha, Nebraska, United States

Location

New York

New York, New York, United States

Location

New York

Rochester, New York, United States

Location

North Carolina

Charlotte, North Carolina, United States

Location

Ohio

Cleveland, Ohio, United States

Location

Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Texas

Dallas, Texas, United States

Location

Texas

Houston, Texas, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Study Officials

• Medical Monitor

  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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 8, 2011
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 18, 2015
• Results First Posted: June 18, 2015

Record last verified: 2015-06

Locations

CA (2); US (20)