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Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation


Phase 3
18 Years
69 Years
Open (Enrolling)
Both
Infection

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Trial Information

Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Undetectable Viral Load

Outcome Description:

The primary endpoint is undetectable viral load at 12 weeks post-transplant (Post-transplant virological response - PTVR). In order to have undetectable HCV RNA viral load after transplant, patients need to have undetectable viral load before the liver transplant. Primary analysis for undetectable viral load at 12 weeks post-transplant response rate based on the modified intent-to-treat (ITT) population. The modified ITT population defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate.

Outcome Time Frame:

48 weeks

Safety Issue:

Yes

Principal Investigator

Harrys A. Torres, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0977

NCT ID:

NCT01821963

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Infection
  • 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
  • Carcinoma
  • Hepatitis
  • Hepatitis C
  • Carcinoma, Hepatocellular

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030