14 results
The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…
The primary endopoint is to determine whether ketoconazole/octreotide combination therapy, followed by octreotide monotherapy, is an effective treatment for Cushing's disease. Secundary endpoints address the effects of this therapy on bone…
Objective: Primary objective: 1.) To study the toxicity of naked DNA vaccines encoding CD8+ T cell epitope from melanosomal antigen MART-1 genetically linked to the gene encoding domain 1 of tetanus toxin subunit C by dose escalation in advanced-…
Aim of the study is to evaluate RPL554*s safety in healthy, non-asthmatic subjects and consequently to assess RPL 554 safety and efficacy in allergic asthmatics and in allergic rhinitics.
The objective of the study is to improve medical treatment of Cushing's disease by combining partially independent medical therapies which act through differential mechanisms. Given the high affinity of SOM230 to sst5 and considering the facts…
Primary objective:To assess the safety of nebulised RPL554 at 2 single, ascending, inhaled doses of 0.036 mg/kg (12X) and 0.072 mg/kg (24X) in allergic asthmatics using standard safety measures with intensive monitoring of any potential…
To evaluate the urodynamic effects, the safety and tolerability and the clinical efficacy of AV608 compared with placebo in subjects with idiopathic detrusor overactivity
The purpose of this study, is to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing*s disease as measured by the proportion of patients achieving normal UFC at the end of the study…
To determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.
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…
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.