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NCT ID: NCT02404025 Completed - Aplastic Anemia Clinical Trials

Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects

Start date: May 12, 2015
Phase: Phase 2
Study type: Interventional

This was an open label, non-randomized, phase II study of eltrombopag in combination with rabbit ATG/CsA in subjects with moderate or more severe AA who did not received prior ATG/ALG-based immunosuppressive therapy. The objective was to assess additive effects of eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA. Subjects were assessed at least weekly for safety during the period from the start of ATG/CsA to 4 weeks after the start of administration of eltrombopag. After that, subjects had visits every 2 weeks until Week 26. Subjects in whom the treatment was assessed as effective at Week 26 could continued treatment with eltrombopag after 6 months when clinically indicated at the discretion of the investigator. There were five follow-up visits: at discontinuation of the treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment discontinuation. As this study was the first Japanese phase II study in which this product was administered in combination with ATG/CsA to subjects with naive moderate or more severe AA, the subject number of this study was determined to be 10 based on the feasibility survey.

NCT ID: NCT02403401 Completed - Contraception Clinical Trials

Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Start date: May 15, 2015
Phase: Phase 3
Study type: Interventional

Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.

NCT ID: NCT02401464 Completed - Clinical trials for Japanese Healthy Adult Males

A Phase I Bioequivalence Study of TAK-536 Pediatric Formulation

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male subjects.

NCT ID: NCT02401191 Completed - Rhinitis Allergic Clinical Trials

A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis

Start date: March 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis. Secondary Objective: To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.

NCT ID: NCT02400905 Completed - Clinical trials for Peripheral Arterial Disease

Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

MIMICS-2
Start date: June 29, 2015
Phase: N/A
Study type: Interventional

To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.

NCT ID: NCT02400788 Completed - Clinical trials for Hepatocellular Carcinoma

Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.

NCT ID: NCT02396862 Completed - Hemophilia A Clinical Trials

Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment

ECHO
Start date: December 9, 2015
Phase:
Study type: Observational

The purpose of the study is to improve the understanding of key patient reported outcomes such as quality of life as well as clinical outcomes in hemophilia A, in a global real world setting.

NCT ID: NCT02396316 Completed - Clinical trials for Glaucoma, Neovascular

Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

VEGA
Start date: April 2015
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.

NCT ID: NCT02396212 Completed - Clinical trials for Systemic Juvenile Idiopathic Arthritis

Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA

Start date: May 7, 2015
Phase: Phase 3
Study type: Interventional

This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.

NCT ID: NCT02395172 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

Start date: March 24, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.