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.
Conditions
Interventions
Trade Name: MabCampath
Product Name: MabCampath
Product Code: Alemtuzumab
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: ALEMTUZUMAB
Concentration unit: mg milligra
Sponsors
Astellas
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Objective: • Patient and graft survival at month 3 after transplantation •Incidence of successful steroid-free treatment •Overall incidence of adverse events with regard to adverse events of special interest (infections, gastrointestinal and neurological disorders, malignancies, haemogram changes) ;Primary end point(s): • Incidence and severity of acute and chronic rejection or time to first acute rejection episode | — |
Countries
Germany
Outcome results
None listed