148 results
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…
• The primary objective of this study is to establish the efficacy of fostamatinib as compared with placebo in achieving a stable platelet response in subjects with persistent/chronic ITP.• Secondary objectives include assessment of the incidence of…
- The studymedication in this clinical study was developed for long-term use in patients with endometriosis associated pelvic pain to release the pain and to avoid to otherwise necessary operation.Primary objective-To assess the dose-response…
To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.
Primary outcome parameter is the amount of intra- and postoperative transfusions required. Secondary outcome parameters include intra- and postoperative blood loss, operation time, and postoperative complications and the outcome of…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
Objective: The primary objective of the study is to determine whether the intracervical installation of vasopressin reduces the incidence and severity of gas embolism as detected by trans oesophageal echocardiography (TOE).The secondary objective is…
The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions,…
The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…
To estimate the treatment effect and safety of AMG 386 in combination with paclitaxel + carboplatin in subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers.
The purpose of the study is to investigate to what extent DA-3880 is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to the above mentioned Aranesp® formulation. In addition, the effect DA-3880 on the number of…
The purpose of the study is to investigate to what extent RAD1901 is tolerated.It will also be investigated how quickly and to what extent RAD1901 is absorbed and eliminated from the body.In addition, in Group 6 it will be investigated to what…
Primary objective:- To assess the safety of concizumab given as multiple s.c. doses to subjects with haemophilia ASecondary objectives:- To assess pharmacokinetics of concizumab in subjects with haemophilia A after multiple s.c. doses- To assess…
The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…
The purpose of the study is research. The study investigates to what extent ANF Rho is tolerated in comparison to Neulasta® (representing standard of care treatment) and placebo. A placebo is the same formulation as the study medication without the…
The objective of this phase IIb is to compare the efficacy and safety of sorafenib to placebo of patients with ovarian epithelial or primary peritoneal cancers stage IIIb and IV who have achieved a complete clinical response after standard platinum/…
To investigate the potential of an interaction between 4 mg/kg sugammadex and aspirin on platelet aggregation using collagen-induced whole blood aggregometry in young healthy male volunteers.
This clinical trial is being performed to evaluate the PK profile of TBS-2 administered as single and multiple (BID) doses in patients with HSDD or ANOR. In addition, the study will evaluate the initial PD efficacy and safety of intranasal TBS-2 BID…
Primary objectives:To confirm the lack of effect of 0.5 mg sublingual testosterone on physiological and subjective measures of sexual arousal in women with HSDD. Secondary objective:To confirm the lack of effect of 0.5 mg sublingual testosterone on…
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.