Clinical trial NCT01821963: Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
Official title: Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Infection
Keywords: Infection
Hepatitis C Genotype 1 Infection
Hepatitis C virus
HCV
Hepatocellular Carcinoma
HCC
Liver Transplantation
Pegylated Interferon Alfa 2a
PegIFN alfa-2a
Ribavirin
RBV
Telaprevir
Incivek
Antiviral drugs
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2013-04-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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-2a by an injection under the skin 1 time a week.

Study Visits:

On the first day you take the study drug:

* You will have an eye exam performed by the study doctor.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis virus.
* You will be asked about any drugs you are taking or side effects you may be having.

Every Week while you are on study:

* You will have a physical exam, including measurement of your vital signs.
* Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus. If part of the blood sample is left over after the Hepatitis C testing, it will be stored in the laboratory as a back-up sample, in case the original samples get lost. This sample may also be used to check if the Hepatitis C virus has become resistant to the study drug. No extra blood will be drawn for this storage.
* You will be asked about any drugs you are taking or side effects you may be having.
* At Weeks 12, 24, 36, and 42, urine will be collected to check for infection and any other side effects to the drugs.

If you can become pregnant, you will have a urine pregnancy test every 4 weeks

Length of Treatment:

You may continue receiving the antiviral therapy for up to 48 weeks, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

Beginning the day after you stop taking antiviral therapy (or the day of transplantation, whichever comes first), you will have up to 24 weeks of follow-up testing performed. About 4 and 20 weeks after your last dose:

* You will have a physical exam, including measurement of your vital signs.
* Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus.
* You will be asked about any side effects you may be having.
* At week 4 only, urine will be collected to check for infection and any other side effects to the drugs.

This is an investigational study. Telaprevir, PegIFN alfa-2a, and RBV are all FDA approved and commercially available for the treatment of HCV infection. The use of these drugs in preventing the HCV infection is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
timeFrame: 12 weeks post-transplant, up to 48 weeks for overall monitoring
Secondary outcomes:
measure: Sustained Virological Response (SVR)
timeFrame: 60 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Harrys A. Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: