Study Stopped
Low referral rate due to new therapeutic options.
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
1 other identifier
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 1, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 6, 2015
CompletedSeptember 24, 2020
September 1, 2020
10 months
March 27, 2013
February 23, 2015
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
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.
12 weeks post-transplant, up to 48 weeks for overall monitoring
Secondary Outcomes (1)
Sustained Virological Response (SVR)
60 weeks
Study Arms (1)
Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
EXPERIMENTALTriple 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.
Interventions
Starting dose: 180 mcg subcutaneously once weekly.
Starting dose: 1,000 mg by mouth daily.
Starting dose: 750 mg by mouth 3 times a day.
Eligibility Criteria
You may qualify if:
- Males or females aged ≥ 18 and ≤ 70 years
- Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum
- HCV genotype 1 infection
- Child-Pugh-Turcotte (CPT) score \< 7 and Model for End-Stage Liver Disease (MELD) score \< 18
- PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)
- Hepatocellular carcinoma within transplant criteria in the United Network for Organ Sharing (UNOS) Region IV:
- Single lesion up to 6 cm, or
- Two or three lesions with largest no greater than 5 cm and the total tumor diameter no greater than 9 cm
- Listed for liver transplantation
- Willingness to give written consent and agree to double contraception
You may not qualify if:
- Decompensated cirrhosis
- Baseline platelet count less than 35,000/µL
- Baseline hemoglobin level less than 10 g/dL
- Baseline absolute neutrophil count less than 750/mm3
- Baseline creatinine clearance \< 50 mL per min.
- Women with a positive pregnancy test at baseline or men whose female partners are pregnant or are contemplating pregnancy
- Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment guidelines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Vertex Pharmaceuticals Incorporatedcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Harrys A. Torres, MD/Assistant Professor, Infectious Diseases
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Harrys A. Torres, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 1, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
September 24, 2020
Results First Posted
March 6, 2015
Record last verified: 2020-09