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NCT ID: NCT03128593 Completed - Clinical trials for Mucopolysaccharidosis II

A Study of JR-141 in Patients With Mucopolysaccharidosis Type II

Start date: March 30, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below, - to collect the safety information of JR-141 - to evaluate the plasma pharmacokinetics of JR-141 - to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and general symptoms

NCT ID: NCT03128411 Completed - Clinical trials for Leukemia, Chronic Myelogenous

Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Start date: May 15, 2017
Phase: Phase 2
Study type: Interventional

Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

NCT ID: NCT03127644 Completed - Hyperkalemia Clinical Trials

ZS Ph2/3 Dose-response Study in Japan

Start date: June 14, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).

NCT ID: NCT03126747 Completed - Clinical trials for Endometriosis and Dysmenorrhea

Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea

Start date: June 29, 2017
Phase:
Study type: Observational

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

NCT ID: NCT03125902 Completed - Clinical trials for Triple-Negative Breast Cancer

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

IMpassion131
Start date: August 25, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

NCT ID: NCT03123939 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Phase III B in Acute Lymphoblastic Leukemia

Start date: April 24, 2017
Phase: Phase 3
Study type: Interventional

This is a single arm, open-label, multi-center, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell Acute Lymphoblastic Leukemia (ALL).

NCT ID: NCT03123848 Completed - Healthy Clinical Trials

A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants

Start date: April 14, 2017
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI fixed-dose combination tablet) in healthy Japanese adult participants.

NCT ID: NCT03117049 Completed - Clinical trials for Non-Small Cell Lung Cancer

Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

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

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

NCT ID: NCT03116841 Completed - Reflux Esophagitis Clinical Trials

Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation

VISTAEXE
Start date: August 2, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on sleep disturbance of patients with reflux esophagitis, who have heartburn and/or regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the maintenance treatment with PPI other than vonoprazan.

NCT ID: NCT03116191 Completed - Clinical trials for Nocturia Due to Nocturnal Polyuria

Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Start date: February 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.