9 results
The study will be performed in 2 parts, Parts A and B. The purpose of the study is to investigate to what extent BN201 is tolerated. It will also be investigated how quickly and to what extent BN201 is absorbed and eliminated from the body (this is…
The primary objective of this study is• To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are• To assess the efficacy of vilaprisan in subjects with uterine fibroids…
Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
The primary objective of the study is to evaluate the efficacy of treatment with AG-348, as assessed by the reduction in transfusion burden.Secondary: The secondary objective of this study is to evaluate the safety of treatment with AG 348.
Primary:• To evaluate the efficacy of treatment with AG-348 compared with placebo in increasing hemoglobin (Hb) concentrationsSecondary:• To evaluate the safety of AG-348• To determine the effect of the study treatment regimens on markers of…
Evaluate the (cost-) effectiveness of ulipristal in comparison with standard surgical treatment for symptomatic uterine fibroids, measured by the symptom severity score of the Uterine Fibroid Symptoms questionnaire (UFS-QOL), a validated Quality of…
Objectives: Primary:• To evaluate the long-term safety and tolerability of AG-348Secondary:• To evaluate the long-term efficacy of AG-348• To evaluate the efficacy of AG-348 in increasing hemoglobin (Hb) concentrations in subjects who previously…
To study the safety and efficacy of mitapivat in the treatment of adult subjects with sickle cell disease.