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Adrenal Hyperplasia, Congenital clinical trials

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NCT ID: NCT05299554 Enrolling by invitation - Clinical trials for Congenital Adrenal Hyperplasia

Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).

NCT ID: NCT05228652 Recruiting - Clinical trials for Adrenal Hyperplasia, Congenital

Questionnaire Study to Assess the Outcomes of the Management of Congenital Adrenal Hyperplasia Individuals

CAH-MaS
Start date: February 28, 2022
Phase:
Study type: Observational

This is a questionnaire study involving women and young girls affected by Congenital Adrenal Hyperplasia (CAH) and their parents. The aim is to obtain information regarding the outcomes of conservative or surgical management of CAH at the Royal Manchester Children's Hospital (RMCH) in the last 50 years, with specific reference to genital appearance and its impact on patient's social/physical/emotional/sexual outcomes. The study wants also investigate on the individuals and parental perspectives on the proposal to take away the option of early childhood surgery for girls with this condition.

NCT ID: NCT05186675 Enrolling by invitation - Clinical trials for Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study

SAAE-BIH
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The most common two subtypes of primary aldosteronism (PA ) are aldosterone producing adenoma (APA) and bilateral idiopathic hyperaldosteronism (IHA). Mineralocorticoid receptor (MR) antagonists is the main treatment for bilateral IHA, because of its side effects, the treatment compliance of those patients is poor. Hence, an alternative therapy is needed in such cases. We hypothesized that superselective adrenal artery embolization (SAAE) could be a suitable alternative approach. To our knowledge, SAAE has so far not been applied to treat bilateral IHA. This study aimed to evaluate the efficacy and safety of SAAE in the treatment of PA patients with bilateral IHA.

NCT ID: NCT05162950 Enrolling by invitation - Clinical trials for Congenital Adrenal Hyperplasia

Effects and Importance of Epinephrine/Adrenalin Deficiency in CAH

Start date: September 1, 2020
Phase:
Study type: Observational

Individuals with CAH produce lower levels of epinephrine (adrenalin) than controls. This can be correlated to the CYP21A2 genotype and is most pronounced in the classic forms. Individuals with CAH have an increased risk of developing hypoglycemia because both cortisol and epinephrine are important counter regulatory hormones. Stress dosing is essential in situations of increased physical stress such as infections with fever for example. Glucocorticoid treatment and stress dosing cannot compensate fully during physical stress neither for the reaction to psychological stress. This may render various types of difficulties in the individual's life. We aim to investigate if the deficient epinephrine production can be confirmed and if it is related to the increased level of anxiety and vulnerability to stress that we observe in the patients. Specific aims of the study: - Analyse the epinephrine/adrenalin production in patients with CAH using measurements of epinephrine and metanephrine in blood, during an exercise test - Assess stress vulnerability and anxiety using validated questionnaires - Correlate the results to severity of disease, CYP21A2 genotype - Investigate if psychological and somatic stress symptoms are related to the epinephrine production capacity.

NCT ID: NCT05128942 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children With CAH

Start date: December 10, 2021
Phase: Phase 2
Study type: Interventional

An investigation of the safety and efficacy of tildacerfont in participants with CAH.

NCT ID: NCT05101902 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

A Study to Determine Eligibility for CAH-301 (A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) [NCT04783181])

Start date: July 1, 2021
Phase:
Study type: Observational

This pre-screening study is designed to determine potential eligibility of adults with classic CAH due to 21-hydroxylase deficiency (21-OHD) for participation in the CAH-301 [NCT04783181] gene therapy trial with BBP-631.

NCT ID: NCT05063994 Completed - Clinical trials for Congenital Adrenal Hyperplasia

Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

CONnECT
Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

NCT ID: NCT04903587 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Gonadal Changes In Congenital Adrenal Hyperplasia Patients

Start date: October 1, 2021
Phase:
Study type: Observational

To detect the prevalence of gonadal changes by US among the patients with CAH. - assess the patients' radiological findings in relation to their hormonal profile. - early management and prevention of complications resulting from possible gonadal dysfunction.

NCT ID: NCT04890444 Recruiting - Pheochromocytoma Clinical Trials

China Adrenal Disease Registry

CASE
Start date: June 1, 2021
Phase:
Study type: Observational

Epidemiologic studies have revealed a tremendous increase in the prevalence of adrenal associated disease and related mortality worldwide. In order to meet all the therapeutic challenges in adrenal disease in China, CASE was founded in 2020. The objective of CASE is to launch an adrenal disease management model based on the Internet health information platform which allows the application and evaluation of adrenal disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of adrenal disease, diagnosis, and treatment.

NCT ID: NCT04806451 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

Start date: June 25, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).