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NCT ID: NCT04074330 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma

Start date: October 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts. The main aims of the study are: - To check for side effects from treatment with TAK-981 given with rituximab. - To check how much TAK-981 participants can tolerate. - To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment. Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons.

NCT ID: NCT04071041 Terminated - Clinical trials for Community-acquired Pneumonia

Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.

ALBUCAP
Start date: October 31, 2019
Phase: Phase 3
Study type: Interventional

Community-acquired pneumonia (CAP) remains a leading cause of death world-wide. Hypoalbuminemia is associated with worse outcomes. However, whether albumin administration would have a beneficial effect in outcome in patients with CAP remains uncertain. This project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with CAP would increase the proportion of clinical stable patients at day 5.

NCT ID: NCT04068610 Terminated - Clinical trials for Metastatic Microsatellite-stable Colorectal Cancer

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

Start date: September 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

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: NCT04065997 Terminated - Clinical trials for Chronic Heart Failure

Apogee International

Start date: September 6, 2019
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Apogee International registry to further confirm safety and efficacy of the HVAD™ System when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a Medtronic HeartWare™ HVAD™ for bridge to transplant and destination therapy indications.

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: NCT04064346 Terminated - ADPKD Clinical Trials

Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease

ACTION
Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 trial consisting of a 2-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm open-label phase (Part 2) to demonstrate the efficacy and safety of lixivaptan in participants with autosomal dominant polycystic kidney disease (ADPKD). Part 1 of the trial is designed to demonstrate the efficacy of lixivaptan in slowing the decline in kidney function as measured by the difference in estimated glomerular filtration rate (eGFR) between the lixivaptan-treated and placebo-treated participants. Part 2 of the study is designed to provide confirmation of the durability of this effect. Additionally, both parts of the study will contribute to understanding the safety of lixivaptan, particularly any effects on liver chemistry tests.

NCT ID: NCT04060862 Terminated - Breast Cancer Clinical Trials

A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

IPATunity150
Start date: November 15, 2019
Phase: Phase 3
Study type: Interventional

The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.

NCT ID: NCT04059094 Terminated - Cystic Fibrosis Clinical Trials

A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1

Start date: September 16, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic 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.