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NCT ID: NCT03668236 Active, not recruiting - Septic Shock Clinical Trials

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

CLASSIC
Start date: November 27, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

NCT ID: NCT03666780 Active, not recruiting - Atrial Fibrillation Clinical Trials

Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study

LISA
Start date: November 16, 2018
Phase:
Study type: Observational

Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.

NCT ID: NCT03659916 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

NCT ID: NCT03658967 Active, not recruiting - Clinical trials for Secondary Lymphedema

Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)

AdeLE
Start date: June 7, 2018
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.

NCT ID: NCT03651128 Active, not recruiting - Multiple Myeloma Clinical Trials

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

KarMMa-3
Start date: April 16, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

NCT ID: NCT03631199 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

CANOPY-1
Start date: December 21, 2018
Phase: Phase 3
Study type: Interventional

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

NCT ID: NCT03625037 Active, not recruiting - DLBCL Clinical Trials

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

EPCORE™ NHL-1
Start date: June 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): - The dose schedule for epcoritamab - The side effects seen with epcoritamab - What the body does with epcoritamab once it is administered - What epcoritamab does to the body once it is administered - How well epcoritamab works against relapsed and/or refractory B-cell lymphoma The trial consists of 3 parts: - a dose-escalation part [Phase 1, first-in-human (FIH)] - an expansion part (Phase 2a) - a dose-optimization part (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: - For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). - For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.

NCT ID: NCT03599245 Active, not recruiting - Multiple Sclerosis Clinical Trials

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Start date: July 12, 2018
Phase: Phase 3
Study type: Interventional

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

NCT ID: NCT03596866 Active, not recruiting - ALK+ Advanced NSCLC Clinical Trials

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

ALTA-3
Start date: April 19, 2019
Phase: Phase 3
Study type: Interventional

Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: - Brigatinib tablets - Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.

NCT ID: NCT03587116 Active, not recruiting - Hemophilia A Clinical Trials

A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)

Start date: July 26, 2018
Phase: Phase 3
Study type: Interventional

To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study. The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.