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NCT ID: NCT04079296 Completed - Clinical trials for Myelodysplastic Syndrome

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

Start date: September 19, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517. This study will also evaluate the clinical response of ASP7517 as well as other measures of anticancer activity of ASP7517.

NCT ID: NCT04079062 Completed - Healthy Volunteers Clinical Trials

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects

Start date: September 12, 2019
Phase: Phase 1
Study type: Interventional

To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.

NCT ID: NCT04077567 Completed - Clinical trials for Rheumatoid Arthritis

An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis

Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).

NCT ID: NCT04075409 Completed - Clinical trials for Healthy Japanese Participants

A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants

Start date: September 30, 2019
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.

NCT ID: NCT04074187 Completed - Clinical trials for Thrombotic Thrombocytopenic Purpura

A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Start date: October 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period. Secondary Objectives: - To evaluate effect of caplacizumab on - prevention of recurrence of TTP (the number of recurrences of TTP) during overall study period. - a composite endpoint consisting of aTTP-related mortality, recurrence of aTTP and major thromboembolic events during study drug treatment - restoring platelet counts as a measure of prevention of further microvascular thrombosis - refractory disease - biomarkers of organ damage: LDH, cardiac troponin I, serum creatinine - plasma exchange (PE) parameters (days of PE and volume of plasma used), days in intensive care unit, days in hospital - cognitive status of Japanese patients - To evaluate safety profile of caplacizumab in Japanese patients - To evaluate effect of caplacizumab on pharmacodynamic (PD) markers in Japanese patients - To evaluate pharmacokinetic (PK) profile of caplacizumab in Japanese patients - To evaluate immunogenicity of caplacizumab in Japanese patients

NCT ID: NCT04072887 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

Start date: September 12, 2019
Phase: Phase 2
Study type: Interventional

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

NCT ID: NCT04071262 Completed - Advanced Cancer Clinical Trials

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer

Start date: December 20, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.

NCT ID: NCT04070495 Completed - Parkinson's Disease Clinical Trials

A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin

Start date: August 27, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.

NCT ID: NCT04067518 Completed - Clinical trials for Acute Lymphoblastic Leukemia

A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

Start date: October 17, 2019
Phase: Phase 2
Study type: Interventional

The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.

NCT ID: NCT04062448 Completed - Clinical trials for Waldenstrom Macroglobulinemia

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)

Start date: September 25, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).