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NCT ID: NCT02807636 Completed - Clinical trials for Urothelial Carcinoma

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

IMvigor130
Start date: June 30, 2016
Phase: Phase 3
Study type: Interventional

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

NCT ID: NCT02806375 Completed - Clinical trials for Primary Myelofibrosis

PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

Start date: January 2016
Phase: Phase 1/Phase 2
Study type: Interventional

A number of groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand, its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft failure and disease progression in myelofibrosis patients.

NCT ID: NCT02805439 Completed - Clinical trials for Major Depressive Disorder

Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment

Start date: March 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to antidepressant therapy.

NCT ID: NCT02804763 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

Start date: June 2, 2016
Phase: Phase 2
Study type: Interventional

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.

NCT ID: NCT02799602 Completed - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

ARASENS
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

NCT ID: NCT02799147 Completed - Clinical trials for Acute Myeloid Leukemia

GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory Leukemia

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Several groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical, unrelated and related allogeneic stem cell transplantation (SCT). Nonetheless for majority of the grafts, except for 10/10 HLA-matched bone marrow, with this type of prophylaxis require concomitant administration of calcineurin inhibitors±MMF, which delays immune reconstitution and development of graft-versus-leukemia (GVL) effect. So, despite reduction of transplant-related mortality, use of PTCy doesn't lead to the reduction of relapse incidence. This is particularly important for relapsed or refractory acute leukemia patients, where, despite all efforts to intensify conditioning regimens, relapses after SCT occur in more than 50% of patients, and long-term survival rarely exceeds 10-20%. In preclinical model of haploidentical SCT the substitution of post-transplantation cyclophosphamide with bendamustine, led to comparable GVHD control, but significantly augmented GVL effect. To test this hypothesis and improve the outcome of allogeneic SCT in refractory acute leukemia patients we initiated a pilot trial with high-dose post-transplantation bendamustine for GVHD prophylaxis. The selection of doses is based on the previous dose-escalation studies. Additional immunosuppression could be added for mismatched grafts.

NCT ID: NCT02798471 Completed - Pulmonary Embolism Clinical Trials

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

NCT ID: NCT02797587 Completed - Smoking Clinical Trials

Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians With HIV (St PETER HIV)

St PETER HIV
Start date: July 19, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized controlled trial (RCT) to compare the effects of varenicline, cytisine, and nicotine replacement therapy (NRT) to reduce: 1) alcohol use and craving, 2) smoking; and 3) inflammation and risk for coronary heart disease (CHD) and mortality among 400 HIV-infected Russians, with heavy alcohol consumption and tobacco use.

NCT ID: NCT02796053 Completed - Psoriasis Vulgaris Clinical Trials

TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment

Start date: April 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08 during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled with current therapy.

NCT ID: NCT02794792 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

IMPRESSION
Start date: May 11, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of ipragliflozin in combination with metformin compared with metformin plus placebo in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin.