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Trial record 43 of 1134 for:    IFNA2 AND Antiviral Agents

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01821963
Recruitment Status : Terminated (Low referral rate due to new therapeutic options.)
First Posted : April 1, 2013
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Infection Drug: Pegylated Interferon Alfa 2a Drug: Ribavirin Drug: Telaprevir Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.
Drug: Pegylated Interferon Alfa 2a
Starting dose: 180 mcg subcutaneously once weekly.
Other Name: PegIFN

Drug: Ribavirin
Starting dose: 1,000 mg by mouth daily.

Drug: Telaprevir
Starting dose: 750 mg by mouth 3 times a day.
Other Name: Incivek

Primary Outcome Measures :
  1. Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant [ Time Frame: 12 weeks post-transplant, up to 48 weeks for overall monitoring ]

    The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.

    Response rate based on the modified intent-to-treat (ITT) population where ITT population is 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.

Secondary Outcome Measures :
  1. Sustained Virological Response (SVR) [ Time Frame: 60 weeks ]
    Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01821963

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Vertex Pharmaceuticals Incorporated
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Principal Investigator: Harrys A. Torres, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01821963     History of Changes
Other Study ID Numbers: 2012-0977
First Posted: April 1, 2013    Key Record Dates
Results First Posted: March 6, 2015
Last Update Posted: March 6, 2015
Last Verified: February 2015
Keywords provided by M.D. Anderson Cancer Center:
Pegylated Interferon Alfa 2a
Antiviral drugs
Hepatitis C Genotype 1 Infection
Hepatitis C virus
Hepatocellular Carcinoma
Liver Transplantation
PegIFN alfa-2a
Additional relevant MeSH terms:
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Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Physiological Effects of Drugs
Communicable Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases
Digestive System Diseases
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Immunologic Factors