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NCT ID: NCT04066491 Terminated - Cholangiocarcinoma Clinical Trials

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

Start date: September 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.

NCT ID: NCT04065841 Terminated - Clinical trials for Non Alcoholic Steatohepatitis (NASH)

Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

ELIVATE
Start date: December 30, 2019
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT04056611 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

FREESIA
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

NCT ID: NCT03970837 Terminated - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

contRAst 2
Start date: June 5, 2019
Phase: Phase 3
Study type: Interventional

This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

NCT ID: NCT03955146 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: June 18, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with IPF.

NCT ID: NCT03944707 Terminated - Asthma Clinical Trials

Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).

NCT ID: NCT03918811 Terminated - Clinical trials for Mechanical Ventilation Complication

Comparison of Two Extubation Techniques in Critically Ill Adult Patients

ExtubAR
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Orotracheal extubation consists in the removal of the endotracheal tube (ETT) when it is no longer required. This procedure may carry a considerable risk of complications and extubation failure. The literature points out two methods of extubation: the traditional method and the positive pressure method. In a noninferiority clinical trial it was demonstrated that EOT with positive pressure and without endotracheal suction was a safe technique and could be better than traditional extubation. Although prior studies reported better clinical outcomes with the positive pressure extubation technique, its superiority has not been deeply studied yet. Therefore, the objective of our study is to determine whether the positive pressure OTE technique, compared with the traditional OTE technique, reduces the incidence of major postextubation complications (up to 60 minutes) in critically ill adult patients.

NCT ID: NCT03911869 Terminated - Brain Metastases Clinical Trials

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

POLARIS
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.

NCT ID: NCT03860844 Terminated - Clinical trials for Acute Myeloid Leukemia

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

ISAKIDS
Start date: August 6, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: - Safety and tolerability assessments - Assessment of infusion reactions (IRs) - Pharmacokinetics (PK) of isatuximab - Minimal residual disease - Overall response rate - Overall survival - Event free survival - Duration of response - Relationship between clinical effects and CD38 receptor density and occupancy

NCT ID: NCT03843125 Terminated - Clinical trials for Systemic Lupus Erythematosus

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

SLE-BRAVE-X
Start date: September 9, 2019
Phase: Phase 3
Study type: Interventional

The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).