Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
NCT01821963 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2020-09-24
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.
Conditions
Interventions
- DRUG
-
Pegylated Interferon Alfa 2a
Starting dose: 180 mcg subcutaneously once weekly.
- DRUG
-
Ribavirin
Starting dose: 1,000 mg by mouth daily.
- DRUG
-
Telaprevir
Starting dose: 750 mg by mouth 3 times a day.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Harrys A. Torres, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2014-02-28
- Completion
- 2014-02-28
Countries
- United States
Study Locations
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