Therapy-optimizing pilot study to investigate the efficacy and safety of an induction therapy with Campath-1H in combination with Tacrolimus for prevention of acute and chronic rejection in patients after primary orthotopic heart transplantation - Heart Cam & Tam

Conditions: Therapy-optimizing pilot study to investigate the efficacy and safety of an induction therapy with Campath-1H in combination with Tacrolimus for prevention of acute and chronic rejection in patients after primary orthotopic heart transplantation.

Registration Number: EUCTR2006-005275-18-DE

Lead Sponsor: Astellas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 10

Inclusion Criteria

•Patients > 18 years
•Patients must have been fully informed about the study and have given
written informed consent prior to study participation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or nursing women
•Multi-organ transplant recipients
•Previous treatment with Campath-1H
•Use of other investigational agents within 6 weeks
•Active systemic infection
•HIV positive patient or donor
•Past history of anaphylaxis following exposure to humanized monoclonal
antibodies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: • Patient and graft survival at month 3 after transplantation<br>•Incidence of successful steroid-free treatment <br>•Overall incidence of adverse events with regard to adverse events of<br> special interest (infections, gastrointestinal and neurological disorders, <br> malignancies, haemogram changes)<br>;Primary end point(s): • Incidence and severity of acute and chronic rejection or time to first acute <br> rejection episode<br>;Main Objective: The objective of this study is to determine the efficacy and safety of induction therapy with Campath-1H and tacrolimus mono-therapy thereafter

Secondary Outcome Measures