Overview

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

Status:
Terminated
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Vertex Pharmaceuticals Incorporated
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
Inclusion Criteria:

1. Males or females aged ≥ 18 and ≤ 70 years

2. Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum

3. HCV genotype 1 infection

4. Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score
< 18

5. PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null
responders and relapsers)

6. Hepatocellular carcinoma within transplant criteria in the United Network for Organ
Sharing (UNOS) Region IV:

1. Single lesion up to 6 cm, or

2. Two or three lesions with largest no greater than 5 cm and the total tumor
diameter no greater than 9 cm

7. Listed for liver transplantation

8. Willingness to give written consent and agree to double contraception

Exclusion Criteria:

1. Decompensated cirrhosis

2. Baseline platelet count less than 35,000/µL

3. Baseline hemoglobin level less than 10 g/dL

4. Baseline absolute neutrophil count less than 750/mm3

5. Baseline creatinine clearance < 50 mL per min.

6. Women with a positive pregnancy test at baseline or men whose female partners are
pregnant or are contemplating pregnancy

7. Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment
guidelines