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NCT ID: NCT03885882 Completed - Healthy Subjects Clinical Trials

A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants

Start date: April 13, 2019
Phase: Phase 1
Study type: Interventional

To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.

NCT ID: NCT03876457 Completed - Clinical trials for Acute Ischemic Stroke

SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

SELECT2
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.

NCT ID: NCT03875534 Completed - Achondroplasia Clinical Trials

A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia

Start date: June 19, 2019
Phase:
Study type: Observational

This is a long-term, multi-center, longitudinal, observational study in children with achondroplasia (ACH). The aim is to study height velocity and comorbidities in children with ACH. This is a natural history study and no study medication will be administered.

NCT ID: NCT03860935 Completed - Heart Diseases Clinical Trials

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

ATTRibute-CM
Start date: March 19, 2019
Phase: Phase 3
Study type: Interventional

Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

NCT ID: NCT03859973 Completed - Schizophrenia Clinical Trials

This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia

Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities. Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer. The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.

NCT ID: NCT03849313 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)

Start date: March 20, 2019
Phase: Phase 1
Study type: Interventional

This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira and US licenced Humira (US-Humira), when administered as a single 40 mg SC dose.

NCT ID: NCT03847909 Completed - Kidney Diseases Clinical Trials

A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2

PHYOX2
Start date: October 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)

NCT ID: NCT03846427 Completed - Clinical trials for Marginal Zone Lymphoma

Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma

MAGNOLIA
Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).

NCT ID: NCT03834519 Completed - Prostatic Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

KEYLYNK-010
Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected.

NCT ID: NCT03829488 Completed - Clinical trials for Kidney Transplant; Complications

Better Evidence for Selecting Transplant Fluids

BEST-Fluids
Start date: January 26, 2018
Phase: Phase 3
Study type: Interventional

End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient. Intravenous fluids given during and after transplantation (usually 0.9% sodium chloride or saline) are critical to preserve kidney transplant function, but there is evidence that 0.9% saline may not be the safest fluid to use due to its high chloride content. BEST Fluids is a randomised controlled trial that aims to find out whether using a balanced low-chloride solution - Plasma-Lyte 148® - as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients.