A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

PHASE4CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 29, 2004

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Heart Transplantation
Interventions
DRUG

Daclizumab

Participants will receive IV daclizumab (2 mg/kg within 6 hours after transplantation and 1 mg/kg every 2 weeks) for a total of five doses.

DRUG

Mycophenolate mofetil

Participants will receive mycophenolate mofetil orally (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg BID within first week and 1 g/day BID from second week onwards) for 6 months.

DRUG

Silrolimus

Participants will receive sirolimus orally (3 mg/day) for 6 months.

Trial Locations (14)

15006

A Coruña

28007

Madrid

28035

Madrid

28041

Madrid

30120

El Palmar Murcia

31008

Pamplona

33006

Oviedo

39008

Santander

41013

Seville

46009

Valencia

47005

Valladolid

08025

Barcelona

08036

Barcelona

08907

L'Hospitalet de Llobregat

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02554955 - A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants | Biotech Hunter | Biotech Hunter