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NCT ID: NCT02148185 Completed - Crohn's Disease Clinical Trials

Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease

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

The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.

NCT ID: NCT02148133 Completed - Cytopaenia Clinical Trials

A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia

Start date: July 23, 2014
Phase: Phase 2
Study type: Interventional

This was a non-randomized, open-label, phase II study to assess the efficacy and safety of eltrombopag in Japanese moderate or more severe aplastic anemia (AA) subjects with a platelet count <30,000/microliter who were refractory to anti-thymocyte globulin (ATG)-based immunosuppressive therapy (IST), who have relapsed after ATG-based IST, or who are ineligible for ATG-based IST. Eltrombopag was expected to improve trilineage blood cells and decrease transfusion frequency based on the result from the previous study in patients with severe AA. This study used the hematologic response rate, defined as the proportion of subjects showing improvement in at least one of the three blood cell lineages or a decrease in blood transfusion volume, as the primary endpoint. A total of 36 subjects were screened and 21 were enrolled in the study. Treatment with eltrombopag started at 25 milligram (mg)/day and increased by 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day. Response assessment was performed at 3 months after starting the study treatment (Week 13). Subjects in whom the treatment was assessed as effective continued with the study treatment. Subjects in whom the treatment was assessed as effective (when meeting any of the response criteria) at 6 months after starting the study treatment (Week 26) might enter the extension phase and continue the treatment with eltrombopag. The primary endpoint was the hematologic response rate at Week26.

NCT ID: NCT02146261 Completed - Healthy Clinical Trials

A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.

NCT ID: NCT02146079 Completed - Healthy Clinical Trials

A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Start date: May 21, 2014
Phase: Phase 1
Study type: Interventional

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.

NCT ID: NCT02145741 Completed - Neoplasms Clinical Trials

Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours

Start date: June 11, 2014
Phase: Phase 1
Study type: Interventional

This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.

NCT ID: NCT02143635 Completed - Clinical trials for Advanced Solid and Hematological TP53wt Tumors

Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt

Start date: July 7, 2014
Phase: Phase 1
Study type: Interventional

To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

NCT ID: NCT02143271 Completed - Clinical trials for Secondary Hyperparathyroidism

Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

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

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

NCT ID: NCT02141659 Completed - Clinical trials for Hormone Treatment-naïve Participants With Prostate Cancer

A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer

Start date: May 1, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.

NCT ID: NCT02141347 Completed - Clinical trials for Part C: Malignant Mesothelioma

Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma

Start date: May 22, 2014
Phase: Phase 1
Study type: Interventional

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

NCT ID: NCT02141074 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

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Start date: July 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.