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NCT ID: NCT02258542 Completed - Asthma Clinical Trials

A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

BORA
Start date: November 19, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

NCT ID: NCT02258451 Completed - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: June 4, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.

NCT ID: NCT02256917 Completed - Clinical trials for Severe Haemophilia A

Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A

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

The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.

NCT ID: NCT02256618 Completed - Clinical trials for Hypoxic-ischemic Encephalopathy

Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Start date: August 2014
Phase: Phase 1
Study type: Interventional

This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

NCT ID: NCT02254356 Completed - Clinical trials for Peripheral Arterial Disease (PAD)

Zilver Flex Post-Market Study in Japan

Start date: May 2012
Phase: N/A
Study type: Interventional

Japanese post market clinical study of the Zilver Flex device.

NCT ID: NCT02254291 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

SUSTAIN™
Start date: October 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

NCT ID: NCT02252133 Completed - Myopia Clinical Trials

DAILIES TOTAL1® Lens Centration in a Japanese Population

Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

NCT ID: NCT02250391 Completed - Clinical trials for Portal Vein Thrombosis

Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis

Start date: September 2014
Phase: Phase 3
Study type: Interventional

Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis. The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and 21 days after administration in comparison with the placebo group.

NCT ID: NCT02250001 Completed - Chronic Hepatitis C Clinical Trials

Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

Start date: September 30, 2014
Phase: N/A
Study type: Observational [Patient Registry]

The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

NCT ID: NCT02248480 Completed - Clinical trials for Osteoarthritis of the Knee

A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.