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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

A multi-center, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO)

Use of iron chelation therapy has demonstrated benefits in terms of morbidity and mortality for chronically-transfused thalassemia patients with iron overload. Recent retrospective data (Leitch 2007, Rose 2010, Sanz 2008) suggest that overall…

A phase IIIB, one year, open label, multicentre, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium injection in subjects with diabetic macular edema (DME)

The primary objective of this study is to further evaluate the safety and tolerability of pegaptanib sodium in subjects with DME.

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B

Primary Objective: To evaluate the haemostatic effect of N9-GP during surgery procedures in patients with haemophilia B.Key Secondary Objectives• To evaluate the haemostatic effect of N9-GP during surgery and the postoperative period.• To evaluate…

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Cephalon Sponsored Study in Eosinophilic Asthma

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed. The secondary objectives of…

A Multi-center, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy
 and Safety of Voclosporin as Therapy in Subjects with Active Non-Infectious Uveitis Involving the
 Intermediate and/or Posterior Segments of the Eye

The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-,…

A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.

To assess the efficacy and safety of treatment with tocilizumab versus adalimumab, both in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis who have had an inadequate efficacy response to treatment with…

A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma

The primary objective of this study is to determine if there is an improvement in progression-free survival(PFS) when siltuximab is added to VELCADE* (bortezomib) and dexamethasone in subjects with relapsedor refractory multiple myeloma.The…

Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the newborn (PPHN)

To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…

A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

The primary objective of this study is to evaluate the efficacy of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC.The secondary objective is to evaluate the safety of EN3348 as compared with…

Ingenio Device Algorithm Study

To gather data to support global submissions/approvals for some models of the Ingenio device family.

TK008:Randomized phase III trial of haploidentical HCTwith or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia

Primary objective:-To compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCTSecondary objectives:- To compare…

A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

To evaluate the long-term safety and efficacy of BMN 110 administration at 2.0 mg/kg/qw and 2.0 mg/kg/qow in patients with MPS IVA.

An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator*s Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy.

Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…

Beyond conventional treatment of Atopic eczema in infants: Management By specific prObiOtic strains. A double blind placebo-controlled trial.

To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in vitro and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD…

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…