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

Stopped early · Phase 3

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT01821963

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2013-04-01

Expected to finish

2014-02-01

Last updated by the study team

2020-09-24

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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