Status:
TERMINATED
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Vertex Pharmaceuticals Incorporated
Conditions:
Infection
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
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 bac...
Detailed Description
Study Drug Administration: If you are found to be eligible to take part in this study, you will take telaprevir 3 times a day. You will take RVB by mouth 2 times a day. You will receive PEGIFN alfa-2...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01821963
Start Date
April 1 2013
End Date
February 1 2014
Last Update
September 24 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030