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NCT ID: NCT03689244 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment

SELECT
Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH.

NCT ID: NCT03656510 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).

NCT ID: NCT03633227 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

Start date: June 22, 2018
Phase: Phase 4
Study type: Interventional

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.

NCT ID: NCT03629249 Terminated - Asthma Clinical Trials

Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

Start date: December 13, 2018
Phase: Phase 3
Study type: Interventional

The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.

NCT ID: NCT03627091 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

CARMEN CD 307
Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

NCT ID: NCT03626545 Terminated - Non-Small-Cell Lung Clinical Trials

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

CANOPY-2
Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

NCT ID: NCT03608033 Terminated - IgA Nephropathy Clinical Trials

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

Start date: February 16, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline.

NCT ID: NCT03600818 Terminated - Clinical trials for Polymyalgia Rheumatica

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: - To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: - Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. - To measure sarilumab serum concentrations in participants with PMR. - To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

NCT ID: NCT03600805 Terminated - Clinical trials for Giant Cell Arteritis

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

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

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: - To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: - Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. - To measure sarilumab serum concentrations in participants with GCA. - To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

NCT ID: NCT03594175 Terminated - Thrombosis Clinical Trials

Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality

READY 1
Start date: February 12, 2020
Phase: Phase 3
Study type: Interventional

Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 18 years and older.