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NCT ID: NCT03759288 Terminated - Crohn's Disease Clinical Trials

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

INTREPID
Start date: December 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

NCT ID: NCT03758443 Terminated - Clinical trials for Ulcerative Colitis (UC)

Efficacy & Safety of TD-1473 in Ulcerative Colitis

RHEA
Start date: March 11, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

NCT ID: NCT03748511 Terminated - Clinical trials for Patients With Fatty Liver Disease

Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease

FLM
Start date: March 5, 2019
Phase:
Study type: Observational

This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .

NCT ID: NCT03742349 Terminated - Clinical trials for Triple Negative Breast Cancer (TNBC)

Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

Start date: January 31, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC. During the dose-escalation part of each treatment arm, patients will be treated with fixed doses of spartalizumab + LAG525 in combination with partner investigational drugs to be escalated until the MTD is reached or a lower RDE is established: NIR178, capmatinib, MCS110, or canakinumab. It is anticipated that other partner study drugs may be added in the future by protocol amendment. After the determination of the MTD/RDE for a particular treatment arm, dose expansion may begin in that arm in order to further assess safety, tolerability, PK/PD, and anti-tumor activity of each combination at the MTD/RDE. Dose expansion arms may initiate only after consideration by the Investigators and Novartis of all available toxicity information, the assessment of risk to future patients from the BLRM, and the available PK, preliminary efficacy, and PD information. There is no requirement for dose-escalation treatment arms reaching an MTD/RDE to proceed to dose expansion.

NCT ID: NCT03738800 Terminated - Lamellar Ichthyosis Clinical Trials

A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

NCT ID: NCT03733444 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care

ISABELA2
Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

NCT ID: NCT03714815 Terminated - Clinical trials for Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

SERENADE OL
Start date: December 7, 2018
Phase: Phase 2
Study type: Interventional

The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

NCT ID: NCT03710291 Terminated - Clinical trials for Chronic Kidney Disease

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

VALOR-CKD
Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

NCT ID: NCT03701763 Terminated - Psoriasis Clinical Trials

Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

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

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

NCT ID: NCT03689985 Terminated - Clinical trials for Aspiration Pneumonia

Functionality and Accuracy of the smART System in Real-Life ICU Settings

Start date: November 7, 2018
Phase: N/A
Study type: Interventional

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Sheba study site there were 2 participants and in the Jefferson study site (identifier NCT03198988) there were 8 participants. This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).