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NCT ID: NCT02985983 Completed - Clinical trials for Axial Spondyloarthritis

A Study of KHK4827 in Subjects With Axial Spondyloarthritis (axSpA)

Start date: March 7, 2017
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of KHK4827 in axSpA (ankylosing spondylitis [AS] and non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.

NCT ID: NCT02985879 Terminated - Clinical trials for Progressive Supranuclear Palsy

A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

Start date: December 12, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

NCT ID: NCT02985593 Completed - Clinical trials for Healthy Men and Subjects With Ulcerative Colitis

A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis

Start date: December 2016
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a placebo-controlled, single-blind comparative study, and to evaluate the safety and tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an open-label study.

NCT ID: NCT02984995 Completed - Clinical trials for Leukemia, Myeloid, Acute

Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation

Start date: December 8, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.

NCT ID: NCT02984982 Completed - Clinical trials for Acute Coronary Syndrome

Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

ODYSSEY J-IVUS
Start date: November 15, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9 months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks prior to randomization, with hypercholesterolemia treated with statin. Secondary Objectives: - To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints including absolute change in percent atheroma volume and normalized TAV after 9 months of treatment. - To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein cholesterol and lipoprotein (a) after 9 months treatment. - To evaluate the safety of alirocumab (Praluent®) including the occurrence of cardiovascular events (coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) throughout the study.

NCT ID: NCT02982863 Completed - Atrial Fibrillation Clinical Trials

Treatment Pattern of Oral Anticoagulants (OAC) in Japan

Start date: December 1, 2016
Phase:
Study type: Observational

1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients 2. To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates. 3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database

NCT ID: NCT02980666 Completed - Clinical trials for Short Bowel Syndrome

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

Start date: January 13, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).

NCT ID: NCT02980341 Completed - Clinical trials for Metastatic Breast Cancer

Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

Start date: November 28, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.

NCT ID: NCT02979587 Active, not recruiting - Clinical trials for Congenital Heart Disease

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

NCT ID: NCT02979522 Active, not recruiting - Hodgkin Disease Clinical Trials

A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Start date: September 6, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).