Trial Outcomes & Findings for Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC) (NCT NCT01821963)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

12 weeks post-transplant, up to 48 weeks for overall monitoring

Results posted on

2020-09-24

Participant Flow

Recruitment Period: April 2013 to February 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.

Study terminated early due to changes in research, alternate therapeutic treatment options.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1

Baseline Characteristics

Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks post-transplant, up to 48 weeks for overall monitoring

Population: Study terminated early with one participant. No analysis possible.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir n=1 participants at risk 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.
Eye disorders Retinopathy	100.0% 1/1 • Number of events 1 • Adverse event data collection through baseline HCV therapy through the Safety Follow-up Visit, with the last visit 24 weeks post end-of-treatment (or following liver transplantation). Overall active study period: May 1 to June 21, 2013. Study terminated early without a treatment completion.
Renal and urinary disorders Nonoliguric acute kidney injury	100.0% 1/1 • Number of events 1 • Adverse event data collection through baseline HCV therapy through the Safety Follow-up Visit, with the last visit 24 weeks post end-of-treatment (or following liver transplantation). Overall active study period: May 1 to June 21, 2013. Study terminated early without a treatment completion.

Additional Information

Harrys A. Torres, MD/Assistant Professor, Infectious Diseases

University of Texas (UT) MD Anderson Cancer Center

Phone: (713) 792-6503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place