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An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

1. Juni 2015 aktualisiert von: Vertex Pharmaceuticals Incorporated

A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation

To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

61

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten
        • Alabama
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten
        • Arizona
    • California
      • Los Angeles, California, Vereinigte Staaten
        • California
    • Colorado
      • Denver, Colorado, Vereinigte Staaten
        • Colorado
    • Florida
      • Bradenton, Florida, Vereinigte Staaten
        • Florida
      • Miami, Florida, Vereinigte Staaten
        • Florida
    • Illinois
      • Evanston, Illinois, Vereinigte Staaten
        • Illinios
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten
        • Indiana
    • Massachusetts
      • Burlington, Massachusetts, Vereinigte Staaten
        • Massachusetts
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten
        • Michigan
      • Detroit, Michigan, Vereinigte Staaten
        • Michigan
    • Missouri
      • St Louis, Missouri, Vereinigte Staaten
        • Missouri
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten
        • Nebraska
    • New York
      • New York, New York, Vereinigte Staaten
        • New York
      • Rochester, New York, Vereinigte Staaten
        • New York
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten
        • North Carolina
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten
        • Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten
        • Pennsylvania
    • Texas
      • Dallas, Texas, Vereinigte Staaten
        • Texas
      • Houston, Texas, Vereinigte Staaten
        • Texas

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male and female participants between the ages of 18 and 65 years
  • History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
  • Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
  • Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response

Exclusion Criteria:

  • Documented cirrhosis after liver transplantation
  • Ascites or hepatic encephalopathy within 6 months before Screening
  • Retransplantation for recurrent hepatitis C
  • Treatment for hepatitis C post liver transplantation
  • History within the past 3 months of: rejection within 3 months or greater than (>) 1 rejection within 12 months
  • Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5 milligram per day) is permitted
  • History within 3 months of any bacterial infection requiring >1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
  • History of post transplant lymphoproliferative disease
  • Acceptable laboratory values at Screening as specified in the protocol
  • Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen
  • History of hepatocellular carcinoma with high risk of recurrence
  • Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
  • Autoimmune-mediated disease
  • History of acute pancreatitis within 5 years before the Screening visit
  • Prior treatment with an hepatitis C virus (HCV) protease inhibitor

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: T/PR + Immunosuppressant Regimen (Tacrolimus)
Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Arzneimittel: Ribavirin
Tablette
Andere Namen:
  • Copegus®, RBV
Arzneimittel: Telaprevir
Tablette
Andere Namen:
  • VX-950
Arzneimittel: Pegyliertes Interferon Alfa-2a
Subkutane Injektion
Andere Namen:
  • Pegasys®, Peg-IFN-alfa-2a
Arzneimittel: Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
Experimental: T/PR + Immunosuppressant Regimen (Cyclosporine)
Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Arzneimittel: Ribavirin
Tablette
Andere Namen:
  • Copegus®, RBV
Arzneimittel: Telaprevir
Tablette
Andere Namen:
  • VX-950
Arzneimittel: Pegyliertes Interferon Alfa-2a
Subkutane Injektion
Andere Namen:
  • Pegasys®, Peg-IFN-alfa-2a
Arzneimittel: Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Zeitfenster: 12 weeks after last planned dose of study drug (up to Week 60)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
12 weeks after last planned dose of study drug (up to Week 60)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
Zeitfenster: 24 weeks after last planned dose of study drug (up to Week 72)
SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
24 weeks after last planned dose of study drug (up to Week 72)
Percentage of Participants With Rapid Viral Response (RVR)
Zeitfenster: Week 4
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
Week 4
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Zeitfenster: Week 4 and Week 12
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.
Week 4 and Week 12
Percentage of Participants With On-Treatment Virologic Failure
Zeitfenster: Baseline up to Week 48
On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.
Baseline up to Week 48
Percentage of Participants With Viral Relapse
Zeitfenster: 48 weeks
48 weeks
Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)
Zeitfenster: 48 weeks
48 weeks
Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications
Zeitfenster: 48 weeks
48 weeks
Percentage of Participants With Biopsy Confirmed and Treated Rejection
Zeitfenster: 48 weeks
48 weeks
Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage
Zeitfenster: 48 weeks
48 weeks
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Zeitfenster: 48 weeks
48 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: Baseline up to Week 52
Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline up to Week 52

Andere Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
Zeitfenster: 4 weeks after last planned dose of study drug (up to Week 52)
4 weeks after last planned dose of study drug (up to Week 52)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vertex Pharmaceuticals Incorporated

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2012

Primärer Abschluss (Tatsächlich)

1. April 2014

Studienabschluss (Tatsächlich)

1. April 2014

Studienanmeldedaten

Zuerst eingereicht

3. November 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2011

Zuerst gepostet (Schätzen)

8. November 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

18. Juni 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2015

Zuletzt verifiziert

1. Juni 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • VX11-950-117

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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