Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
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|ClinicalTrials.gov Identifier: NCT01821963|
Recruitment Status : Terminated (Low referral rate due to new therapeutic options.)
First Posted : April 1, 2013
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: Pegylated Interferon Alfa 2a Drug: Ribavirin Drug: Telaprevir||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
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.
Drug: Pegylated Interferon Alfa 2a
Starting dose: 180 mcg subcutaneously once weekly.
Other Name: PegIFN
Starting dose: 1,000 mg by mouth daily.
Starting dose: 750 mg by mouth 3 times a day.
Other Name: Incivek
- Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant [ Time Frame: 12 weeks post-transplant, up to 48 weeks for overall monitoring ]
The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.
Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate.
- Sustained Virological Response (SVR) [ Time Frame: 60 weeks ]Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821963
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Harrys A. Torres, MD||M.D. Anderson Cancer Center|