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NCT ID: NCT03259308 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 302
Start date: December 5, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03259074 Completed - Clinical trials for Ankylosing Spondylitis

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

SURPASS
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

NCT ID: NCT03258710 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B

Start date: October 2, 2017
Phase: Phase 4
Study type: Interventional

Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chronic hepatitis B associated with HBV growth and abnormal liver function. This study has been planned to evaluate the virological effects and safety of switching from ETV to TDF in chronic hepatitis B (hepatitis B e-antigen [HBeAg])-positive and HBV- deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center, one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV. After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects will be screened to achieve 65 evaluable subjects.

NCT ID: NCT03257852 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

Start date: September 29, 2017
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).

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: NCT03255356 Not yet recruiting - Anesthesia, General Clinical Trials

Ventilation in Cardiac Surgery

VENICE
Start date: November 1, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

NCT ID: NCT03255226 Recruiting - Clinical trials for Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

Start date: February 13, 2018
Phase: Phase 3
Study type: Interventional

To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload

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