11 results
Objectives:To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose. The secondary objective is to…
The purpose of the study is to investigate how quickly Danoprevir is absorbed and the extent of absorption and elimination from the body (this is called pharmacokinetics and bioavailability) when it is administered intravenously (IV) or orally alone…
1. Normalization of the abnormal serum TH parameters and thereby improving the clinical condition of the AHDS patients2. Observation of changes in cognitive and motor function.
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).
Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
To evaluate LFS after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
The main objective of this study is to investigate whether kidney transplant recipient suffering from a tacrolimus-induced tremor can benefit from switching from conventional tacrolimus to LCPT, a new extended release preparation of tacrolimus (…
To compare the efficacy of alitretinoin and cyclosporine in the treatment of hand eczema.
Primary Objective:• To evaluate the effects of withdrawal of tiratricol treatment (placebo group) on serum total triiodothyronine (T3) concentrations, measured by liquid chromatography with tandem mass spectrometry (LC/MS/MS), and the requirement…
Part I:Primary Objective: Evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, as measured by the Gross Motor Function Measure (GMFM)-88 and Bayley Scales of Infant Development (BSID-III) Gross Motor Skill Domain…