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

1 septembre 2020 mis à jour par: M.D. Anderson Cancer Center

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

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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

1

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Houston, Texas, États-Unis, 77030
        • University of Texas MD Anderson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 69 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Pegylated Interferon Alfa 2a
Starting dose: 180 mcg subcutaneously once weekly.
Autres noms:
  • PegIFN
Médicament: Ribavirin
Starting dose: 1,000 mg by mouth daily.
Médicament: Telaprevir
Starting dose: 750 mg by mouth 3 times a day.
Autres noms:
  • Incivek

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
Délai: 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.
12 weeks post-transplant, up to 48 weeks for overall monitoring

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sustained Virological Response (SVR)
Délai: 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.
60 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

M.D. Anderson Cancer Center

Collaborateurs

Vertex Pharmaceuticals Incorporated

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2013

Achèvement primaire (Réel)

1 février 2014

Achèvement de l'étude (Réel)

1 février 2014

Dates d'inscription aux études

Première soumission

27 mars 2013

Première soumission répondant aux critères de contrôle qualité

27 mars 2013

Première publication (Estimation)

1 avril 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2020

Dernière vérification

1 septembre 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2012-0977

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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