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NCT ID: NCT03910530 Completed - Clinical trials for Advanced Solid Tumors

A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors

Start date: July 22, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

NCT ID: NCT03909295 Terminated - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.

Start date: May 7, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301 (PARAGON-HF).

NCT ID: NCT03908970 Completed - Atopic Dermatitis Clinical Trials

Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

Start date: March 25, 2019
Phase: Phase 3
Study type: Interventional

To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.

NCT ID: NCT03907878 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines

Start date: April 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses. The study population consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH. This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.

NCT ID: NCT03906695 Active, not recruiting - Clinical trials for Lower-risk Myelodysplastic

Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes

Start date: March 15, 2019
Phase: Phase 1
Study type: Interventional

To investigate the tolerability and safety of ASTX727 in Japanese subjects with lower-risk MDS.

NCT ID: NCT03906461 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

LSI (Lesion Index) Workflow Observational Study

Start date: May 17, 2019
Phase:
Study type: Observational

This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.

NCT ID: NCT03906331 Available - Breast Cancer Clinical Trials

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Start date: n/a
Phase:
Study type: Expanded Access

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

NCT ID: NCT03905798 Completed - Status Epilepticus Clinical Trials

LORA-PITA IV General Investigation

Start date: November 18, 2019
Phase:
Study type: Observational

Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

NCT ID: NCT03905525 Completed - Sjögren Syndrome Clinical Trials

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

TWINSS
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

NCT ID: NCT03904693 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

A DUE
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.