A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

Sponsoren

Hauptsponsor: Vertex Pharmaceuticals Incorporated

Quelle Vertex Pharmaceuticals Incorporated
Kurze Zusammenfassung

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

Gesamtstatus Completed
Anfangsdatum February 2012
Fertigstellungstermin December 2013
Primäres Abschlussdatum September 2013
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) 12 weeks
Sekundäres Ergebnis
Messen Zeitfenster
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. up to 48 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) 24 weeks
The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment up to week 12
The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment up to 48 weeks
The association of the IL-28B genotype with SVR12 12 weeks
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure After the last planned dose of study drug or after time of failure
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations 12 weeks
Einschreibung 103
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: VX-222

Beschreibung: tablet, 400-mg twice daily

Armgruppenetikett: Quadruple Regimen

Interventionsart: Drug

Interventionsname: telaprevir

Beschreibung: tablet, 1125-mg twice daily

Armgruppenetikett: Quadruple Regimen

Anderer Name: Incivek, VX-950, Incivo

Interventionsart: Drug

Interventionsname: ribavirin

Beschreibung: tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily

Armgruppenetikett: Quadruple Regimen

Anderer Name: Copegus

Interventionsart: Biological

Interventionsname: peginterferon-alfa-2a

Beschreibung: subcutaneous injection, 180-mcg, once weekly

Armgruppenetikett: Quadruple Regimen

Anderer Name: Pegasys

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Subjects must have genotype 1 Chronic Hepatitis C

- Subjects must have compensated cirrhosis

- Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered

- Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

Exclusion Criteria:

- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor

- Any contraindication to Peg-IFN or RBV therapy

- Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices

- A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Medical Monitor Study Director Vertex Pharmaceuticals Incorporated
Ort
Einrichtung:
| Birmingham, Alabama, United States
| San Diego, California, United States
| Englewood, Colorado, United States
| Bradenton, Florida, United States
| Jacksonville, Florida, United States
| Tampa, Florida, United States
| Marietta, Georgia, United States
| Chicago, Illinois, United States
| Indianapolis, Indiana, United States
| Boston, Massachusetts, United States
| Detroit, Michigan, United States
| Lebanon, New Hampshire, United States
| Egg Harbor Township, New Jersey, United States
| Manhasset, New York, United States
| New York, New York, United States
| Rochester, New York, United States
| Asheville, North Carolina, United States
| Charlotte, North Carolina, United States
| Durham, North Carolina, United States
| Cincinnati, Ohio, United States
| Providence, Rhode Island, United States
| Germantown, Tennessee, United States
| Arlington, Texas, United States
| Houston, Texas, United States
| San Antonio, Texas, United States
| Norfolk, Virginia, United States
| Madison, Wisconsin, United States
| Milwaukee, Wisconsin, United States
| Vancouver, British Columbia, Canada
| London, Ontario, Canada
| Montreal, Quebec, Canada
| Hamburg, Germany
| Heidelberg, Germany
| Hessen, Germany
| Koeln, Germany
| Saschen, Germany
| Stuttgart, Germany
| Bialystok, Poland
| Myslowice, Poland
| Wroclaw, Poland
| London, United Kingdom
| Plymouth, United Kingdom
| Scotland, United Kingdom
Standort Länder

Canada

Germany

Poland

United Kingdom

United States

Überprüfungsdatum

October 2014

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Quadruple Regimen

Art: Experimental

Beschreibung: All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.

Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov