Clinical trial NCT01467505: An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
timeFrame: 12 weeks after last planned dose of study drug (up to Week 60)
Secondary outcomes:
measure: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
timeFrame: 24 weeks after last planned dose of study drug (up to Week 72)
measure: Percentage of Participants With Rapid Viral Response (RVR)
timeFrame: Week 4
measure: Percentage of Participants With Extended Rapid Viral Response (eRVR)
timeFrame: Week 4 and Week 12
measure: Percentage of Participants With On-Treatment Virologic Failure
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Viral Relapse
timeFrame: 48 weeks
measure: Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)
timeFrame: 48 weeks
measure: Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications
timeFrame: 48 weeks
measure: Percentage of Participants With Biopsy Confirmed and Treated Rejection
timeFrame: 48 weeks
measure: Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage
timeFrame: 48 weeks
measure: Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
timeFrame: 48 weeks
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
Other outcomes:
measure: Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
timeFrame: 4 weeks after last planned dose of study drug (up to Week 52)
Locations:
city: Birmingham
country: United States
facility: Alabama
state: Alabama
city: Phoenix
country: United States
facility: Arizona
state: Arizona
city: Los Angeles
country: United States
facility: California
state: California
city: Denver
country: United States
facility: Colorado
state: Colorado
city: Bradenton
country: United States
facility: Florida
state: Florida
city: Miami
country: United States
facility: Florida
state: Florida
city: Evanston
country: United States
facility: Illinios
state: Illinois
city: Indianapolis
country: United States
facility: Indiana
state: Indiana
city: Burlington
country: United States
facility: Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan
state: Michigan
city: Detroit
country: United States
facility: Michigan
state: Michigan
city: St Louis
country: United States
facility: Missouri
state: Missouri
city: Omaha
country: United States
facility: Nebraska
state: Nebraska
city: New York
country: United States
facility: New York
state: New York
city: Rochester
country: United States
facility: New York
state: New York
city: Charlotte
country: United States
facility: North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Ohio
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Texas
state: Texas
city: Houston
country: United States
facility: Texas
state: Texas
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: