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NCT ID: NCT03827018 Completed - Clinical trials for Giant Cell Arteritis

KPL-301 for Subjects With Giant Cell Arteritis

Start date: September 20, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

NCT ID: NCT03826628 Completed - Tuberous Sclerosis Clinical Trials

Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

Start date: July 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The study aims to compare the safety and efficacy of two different strengths of Rapamycin cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC).

NCT ID: NCT03826537 Completed - Tutin Poisoning Clinical Trials

A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body

Start date: January 2012
Phase: N/A
Study type: Interventional

Honey available in New Zeland can contain the toxins tutin and hyenanchin. Tutin is produced by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and hyenanchin for honey production. Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand since the 1800s, with the most recent outbreak in 2008. The study aims to find out how tutin and hyenanchin are absorbed and processed by the body. This information will help the FSANZ give guidance on acceptable levels of tutin and hyenanchin in honey. About 6 healthy men will each take a single dose of honey containing known concentrations of tutin and hyenanchin. This dose level is similar to what someone who eats a lot of honey would have, if the honey contained the maximum level of tutin allowed under the Food Standards Code. Blood tests to measure tutin and hyenanchin levels will be taken at certain times after dosing, and any side effects will be recorded.

NCT ID: NCT03824405 Completed - Atopic Dermatitis Clinical Trials

Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

Start date: February 4, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.

NCT ID: NCT03815396 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

rhAAT-Fc
Start date: July 19, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.

NCT ID: NCT03815357 Completed - Clinical trials for Primary Immunodeficiency

What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?

Start date: January 31, 2017
Phase:
Study type: Observational

This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD. Aims and/or research question of the project 1. To determine the incidence of primary immunodeficiency in children >2 years who present with IPD 2. To determine the types of immunodeficiency associated with IPD in children

NCT ID: NCT03792555 Completed - Acromegaly Clinical Trials

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

Start date: December 18, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.

NCT ID: NCT03789656 Completed - Acromegaly Clinical Trials

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

NCT ID: NCT03783377 Completed - Clinical trials for Hypertriglyceridemia

Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)

Start date: March 8, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).

NCT ID: NCT03783078 Completed - Clinical trials for Merkel Cell Carcinoma

Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

Start date: February 25, 2019
Phase: Phase 3
Study type: Interventional

This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.