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A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered
as a Single Agent Every 2 Weeks in Patients With Previously-
Treated, Advanced or Metastatic Soft Tissue and Ewing's
Sarcoma/PNET

The primary objective of this study is to determine the progression-free survival (PFS) rate assessed 12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to patients with previously-treated, advanced or metastatic soft…

A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

Primary Objective: • The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.Secondary Objectives: • Evaluate safety and tolerability of…

Randomized phase II study using a non-myeloablative lymphocyte depleting regimen of chemotherapy followed by infusion of tumor infiltrating lymphocytes and interleukin-2 in metastatic melanoma

A pilot feasibility study (n=5) will be performed to evaluate the feasibility (logistics, timing) and safety of administering autologous tumor infiltrating lymphocytes (TIL) generated at the NKI-AVL infused in conjunction with systemic high-dose…

Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery

To determine whether fibrinogen concentrate infusion reduces perioperative blood loss and transfusion in patient experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery and to determine whether its use is safe…

Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination
with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLC

To evaluate the anti-tumor activity of a docetaxel/carboplatin regimen in patients with refractory or relapsed SCLC. Furthermore to asses the safety profile of the docetaxel/carboplatin combination.In patients who have experienced FN, the efficacy…

Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles

Objective of this study is the evaluation of contraceptive patches with EE and GSD. The inhibition of ovulation of three different patch formulations will be evaluated. Secondary objectives are the course of gonadotropins, estradiol and progesterone…

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Diabetic Macular Edema.

The purpose of this study is to evaluate if microplasmin is safe and effective when injected into the vitreous without performing a vitrectomy.

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis

to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered to Treatment-Naïve Subjects with Chronic Hepatitis C (CHC) Infection

Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…

Tryptophan enriched diet to improve affective and cognitive functions in patients with multiple sclerosis

The purpose of this study is to test the acute effects of a TRP enriched meal in a dose-dependent manner in MS patients. The results of MS patients without mood disturbances (control group) will be compared to MS patients with mood disturbances (…

A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function

The purpose of the trial is to determine the effect of multiple doses of tolvaptan on renal function in patients with autosomal dominant polycystic kidney disease (ADPKD) at various stages of renal function. Additionally, the short-term renal…

Achieving appropriate exposuRe to RIBAvirin after a dose advise based on an abbreviated AUC of a first dose of ribavirin (ARRIBA)

Primary objective: To evaluate if adequate exposure to ribavirin can be achieved after a dose adjustment based on the AUC0-4h from a first dose of ribavirin.Secondary:• To evaluate how many patients need a dose adjustment to achieve adequate…

A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors

The primary objective of the study is to demonstrate the superiority of the combination BAY 60 4552 / vardenafil over vardenafil alone in the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors.The…

A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy

Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…

Phase II study of Cetuximab combined with Cisplatin or Carboplatin/Pemetrexed as first line treatment in patients with malignant pleural mesothelioma

By adding Cetuximab to standard treatment, we hope to prolonge progression free survival