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NCT ID: NCT03257267 Completed - Clinical trials for Squamous Cell Carcinoma (SCC)

Study of Cemiplimab in Adults With Cervical Cancer

Start date: September 5, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: - To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy - To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy - To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

NCT ID: NCT03256552 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD

Start date: January 28, 2015
Phase: Phase 2
Study type: Interventional

The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

NCT ID: NCT03254758 Completed - Clinical trials for Decompensated Liver Cirrhosis

A Study of ADR-001 in Patients With Liver Cirrhosis

Start date: July 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase 2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated against the same target population in Phase 2.

NCT ID: NCT03254147 Completed - Atrial Fibrillation Clinical Trials

Medical Need of OAC Reversal

Start date: October 15, 2017
Phase:
Study type: Observational

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

NCT ID: NCT03254134 Completed - Atrial Fibrillation Clinical Trials

Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Start date: October 20, 2017
Phase:
Study type: Observational

This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

NCT ID: NCT03254108 Completed - Clinical trials for Congestive Heart Failure

Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Start date: November 6, 2017
Phase: N/A
Study type: Interventional

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

NCT ID: NCT03252587 Completed - Clinical trials for Systemic Lupus Erythematosus

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Start date: September 21, 2017
Phase: Phase 2
Study type: Interventional

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

NCT ID: NCT03251482 Completed - Clinical trials for VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

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Start date: November 13, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).

NCT ID: NCT03250325 Completed - Synovial Sarcoma Clinical Trials

Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma

Start date: September 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.

NCT ID: NCT03249714 Completed - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Start date: March 15, 2018
Phase: Phase 2
Study type: Interventional

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries