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NCT ID: NCT03648541 Completed - Colitis, Ulcerative Clinical Trials

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

NCT ID: NCT03645863 Completed - Healthy Clinical Trials

Effects of Iron Supplements on the Pharmacokinetics of MT-6548

Start date: August 27, 2018
Phase: Phase 3
Study type: Interventional

The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.

NCT ID: NCT03645421 Completed - Type 2 Diabetes Clinical Trials

Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes

Start date: August 10, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects. The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.

NCT ID: NCT03645330 Completed - Clinical trials for Non-small-Cell Lung Cancer

A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)

Start date: August 15, 2018
Phase:
Study type: Observational

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

NCT ID: NCT03644784 Completed - Clinical trials for Aortic Valve Insufficiency

Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.

ASSESS-REGURGE
Start date: September 1, 2017
Phase:
Study type: Observational

The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve. After the implementation of the acquisition protocol, each participating site will use the standardized approach for their center in order to identify if the images are considered analyzable via videodensitometry quantitative assessment of aortic regurgitation.

NCT ID: NCT03643952 Completed - Bacteremia Clinical Trials

Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)

Start date: December 6, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive cocci.

NCT ID: NCT03643484 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

IMFINZI Specific-Clinical Experience Investigation in Patients With NSCLC After Definitive Chemoradiation Therapy

Start date: October 24, 2018
Phase:
Study type: Observational [Patient Registry]

To investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with the product as maintenance therapy after definitive chemoradiation therapy.

NCT ID: NCT03643211 Completed - Ulcerative Colitis Clinical Trials

Xeljanz Special Investigation for Long-term Use in UC Patients

Start date: June 8, 2018
Phase:
Study type: Observational

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

NCT ID: NCT03642613 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

The Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD.

STEP-COPD
Start date: September 14, 2018
Phase:
Study type: Observational [Patient Registry]

This study is conducted as a multicenter, non-interventional, cross-sectional study. Patients will be enrolled in the study by a continuous registration method after patients provide written informed consent. After providing informed consent, patients will answer the questionnaires and start measurement with an accelerometer within four weeks. Activities will be measured for 14 consecutive days.

NCT ID: NCT03642132 Terminated - Ovarian Cancer Clinical Trials

Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

Start date: July 19, 2018
Phase: Phase 3
Study type: Interventional

JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.