5 results
The primary purpose of the study is to investigate whether the new 20 mg capsule of Orfadin® (nitisinone) has a similar bioavailability in the body (gives the same concentration in the blood) as two of the marketed capsules of 10 mg. The secundary…
The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…
to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of the liver or lungs
The primary objective is to evaluate safety and tolerability of treatment with AP01.This study will also evaluate the effect of AP01 on various efficacy measures as follows:* To evaluate the safety and tolerability of treatment with AP01 when given…
• Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF prior to regulatory approval or until the study is terminated• To evaluate safety outcomes of patients on AP01 therapy