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NCT ID: NCT03765944 Completed - Clinical trials for Bioequivalence Study

Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets

Start date: December 5, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults

NCT ID: NCT03765918 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

NCT ID: NCT03765242 Completed - Atrial Fibrillation Clinical Trials

Evaluation of Safety and Effectiveness on Oral Anticoagulants

RCR-OAC
Start date: September 21, 2018
Phase:
Study type: Observational

This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment

NCT ID: NCT03764501 Recruiting - Fractures, Bone Clinical Trials

Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy

Start date: May 21, 2018
Phase: N/A
Study type: Interventional

Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

NCT ID: NCT03761849 Completed - Huntingtons Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

NCT ID: NCT03761797 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes

Start date: January 15, 2019
Phase:
Study type: Observational

Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

NCT ID: NCT03761108 Recruiting - Multiple Myeloma Clinical Trials

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

LINKER-MM1
Start date: January 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to learn about the safety of REGN5458 and to find out what is the best dose of REGN5458 to give to patients with multiple myeloma. An additional purpose is to look for any signs that REGN5458 can treat cancer. The study is looking at several other research questions, including: - Side effects that may be experienced by people receiving REGN5458 - How REGN5458 works in the body - How much REGN5458 is present in the blood - How REGN5458 may work to treat cancer

NCT ID: NCT03759600 Completed - Ovarian Cancer Clinical Trials

Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer

Start date: December 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.

NCT ID: NCT03759587 Completed - Ovarian Cancer Clinical Trials

Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

Start date: December 28, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents.

NCT ID: NCT03759379 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.