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NCT ID: NCT03942211 Terminated - Clinical trials for Sarcoidosis-associated Pulmonary Hypertension

A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag

SPHINX
Start date: February 26, 2021
Phase: Phase 2
Study type: Interventional

Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH). The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

NCT ID: NCT03893565 Terminated - Colitis, Ulcerative Clinical Trials

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

NCT ID: NCT03893331 Terminated - Clinical trials for Ablation of Arrhythmia's

AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)

DISCOVER
Start date: June 13, 2019
Phase:
Study type: Observational [Patient Registry]

AcQMap Registry is an observational study

NCT ID: NCT03889496 Terminated - Diabetes Mellitus Clinical Trials

Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin

GLP1-ex-vivo
Start date: November 16, 2015
Phase: N/A
Study type: Interventional

The main goal is to study the correlation of pancreatic uptake of In-111-DTPA-exendin-4 (measured by ex vivo counting) with the beta cell mass determined in the pancreatic specimens obtained after surgery.

NCT ID: NCT03879278 Terminated - Amyloidosis Clinical Trials

Multiple Ascending Dose Study in Healthy Subjects

Start date: March 6, 2019
Phase: Phase 1
Study type: Interventional

This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo.

NCT ID: NCT03877198 Terminated - Hypoxia Clinical Trials

Comparison of Oxygen Controllers in Preterm InfanTs

COCkPIT
Start date: February 19, 2019
Phase: N/A
Study type: Interventional

Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.

NCT ID: NCT03871829 Terminated - Multiple Myeloma Clinical Trials

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

NCT ID: NCT03871348 Terminated - Metastatic Neoplasm Clinical Trials

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Start date: January 3, 2019
Phase: Phase 1
Study type: Interventional

Primary Objectives: - Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. - Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma. Secondary Objectives: - To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab. - To assess the immunogenicity of SAR441000. - To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab. - To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000. - To determine the recommended dose of SAR441000 for the expansion phase.

NCT ID: NCT03867851 Terminated - Clinical trials for Diabetes Mellitus, Type 1

Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation

Start date: February 8, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II open, randomized, active comparator-controlled multi center study in patients with severe type-1 diabetes. This is a two-armed study where patients are randomized in a 2:1 ratio between IBsolvMIR and heparin. Eighteen patients are planned to be included. The study consists of up to 8 visits; screening, transplantation surgery with bolus administration of study drug or active comparator, IBsolvMIR doses on day 1, 3 and 6 after surgery, follow up visits on day 7 and 14, and follow-up phone call on day 44. The primary endpoint is to study AEs up to 44 days following study drug administration. The secondary endpoints are to evaluate changes in TAT, C-peptide, C3a and HGF at baseline and during the first 24 hours after study drug administration, as well as evaluate a change in levels of C-peptide-glucose-creatinine ratio on day 14 compared to baseline.

NCT ID: NCT03866577 Terminated - Clinical trials for Immune Thrombocytopenic Purpura (ITP)

Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

Start date: December 21, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.