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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01467505
First received: November 3, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Drug: ribavirin
Drug: peginterferon alfa-2a
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) [ Time Frame: 12 weeks after the last planned dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24) [ Time Frame: up to Week 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) [ Time Frame: up to Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects with viral relapse [ Time Frame: up to 96 Weeks ] [ Designated as safety issue: No ]
  • PK of telaprevir, Peg-IFN, RBV, and selected immunosuppressant medications [ Time Frame: up to Week 48 ] [ Designated as safety issue: No ]
  • Dose titration requirements of selected immunosuppressant medications [ Time Frame: up to week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with biopsy confirmed and treated rejection during treatment through 24 weeks after the last planned dose of study drug [ Time Frame: 24 weeks after the last planned dose of study drug ] [ Designated as safety issue: No ]
  • Proportion of subjects with histological evidence of stabilization or improvement in inflammation grade or fibrosis stage, 24 weeks after the last planned dose of study drug compared to baseline [ Time Frame: 24 weeks after the last planned dose of study drug ] [ Designated as safety issue: No ]
  • Changes in amino acid sequence of the HCV NS3•4A protease region [ Time Frame: up to 96 Weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Naive and Experienced Pre-transplant
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks followed by Peg-IFN-alfa-2a + RBV for 36 weeks
Drug: Telaprevir
1125 mg bid for 12 weeks
Drug: ribavirin
Initial dose of 600 mg total daily dose with goal of up to 1000mg-1200mg total daily dose based on body weight for 48 weeks
Drug: peginterferon alfa-2a
180 mcg/week for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 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 P/R treatment or experienced with P/R prior to transplantation with relapse, partial, or null response

Exclusion Criteria:

  • 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 > 1 rejection within 12 months
  • Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5 mg/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 HIV1/2 EIA antibody screen or Hepatitis B 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 HCV protease inhibitor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467505

  Show 22 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01467505     History of Changes
Other Study ID Numbers: VX11-950-117
Study First Received: November 3, 2011
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014