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Interferon

Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir for Infections

Phase 3
Waitlist Available
Led By Harrys A. Torres, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post-transplant, up to 48 weeks for overall monitoring
Awards & highlights

Summary

The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant. Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.

Eligible Conditions
  • Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-transplant, up to 48 weeks for overall monitoring
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post-transplant, up to 48 weeks for overall monitoring for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
Secondary outcome measures
Sustained Virological Response (SVR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pegylated Interferon Alfa 2a + Ribavirin + TelaprevirExperimental Treatment3 Interventions
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (\< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon alfa
Not yet FDA approved
Ribavirin
FDA approved
Telaprevir
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,700 Total Patients Enrolled
22 Trials studying Infections
9,188 Patients Enrolled for Infections
Vertex Pharmaceuticals IncorporatedIndustry Sponsor
251 Previous Clinical Trials
32,863 Total Patients Enrolled
3 Trials studying Infections
256 Patients Enrolled for Infections
Harrys A. Torres, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
~0 spots leftby Sep 2025
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