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NCT ID: NCT04271475 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

MACiTEPH
Start date: July 7, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

NCT ID: NCT04244396 Terminated - Clinical trials for Persistent Atrial Fibrillation

Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study

PerAF APAC
Start date: February 25, 2020
Phase:
Study type: Observational

The objective of this clinical trial is to collect safety and effectiveness data for the TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE) in the APAC patient population for the treatment of drug refractory, symptomatic persistent atrial fibrillation when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures.

NCT ID: NCT04237649 Terminated - Solid Tumors Clinical Trials

KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

Start date: February 20, 2020
Phase: Early Phase 1
Study type: Interventional

The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.

NCT ID: NCT04231188 Terminated - Clinical trials for User Experience of Mobile Application

User Experience of a Mobile Application

SMart
Start date: December 26, 2019
Phase:
Study type: Observational

To evaluate the user experience of the use of the different modules / trackers in the mobile application in recording primary caregiver reported outcomes of infants

NCT ID: NCT04210843 Terminated - Clinical trials for Chronic Spontaneous Urticaria

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

NCT ID: NCT04191356 Terminated - Heart Failure Clinical Trials

Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients

Start date: October 17, 2020
Phase:
Study type: Observational

Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Although functional status can be objectively measured by peak exercise oxygen consumption, it is difficult and impractical to implement in large clinical studies, especially in an ambulatory real-world setting. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. The goal of this observational study is to evaluate the feasibility of monitoring functional capacity among patients with heart failure (HF) using mobile health monitoring platforms. Everion® and Apple Watch Series 4 and above will be used for this study. The BiovitalsHF® mobile app can capture patients' key cardiopulmonary physiological parameters, functional capacity (using activity patterns, including guided mobile-based 6MWT, audio recording) and assessment of QoL through validated PROs.

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: NCT04000529 Terminated - Colorectal Cancer Clinical Trials

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Start date: July 30, 2019
Phase: Phase 1
Study type: Interventional

This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

NCT ID: NCT03995407 Terminated - Pressure Ulcer Clinical Trials

100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing.

Start date: June 20, 2019
Phase: N/A
Study type: Interventional

This study seeks to evaluate if a 100% whey protein based diet enhances pressure ulcer healing.

NCT ID: NCT03952325 Terminated - Breast Cancer Clinical Trials

Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC

CONTESSA TRIO
Start date: July 9, 2019
Phase: Phase 2
Study type: Interventional

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.