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Chronic Hypoparathyroidism clinical trials

View clinical trials related to Chronic Hypoparathyroidism.

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NCT ID: NCT05778071 Active, not recruiting - Clinical trials for Endocrine System Diseases

Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism

CALYPSO
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 28 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.

NCT ID: NCT05239221 Completed - Clinical trials for Chronic Hypoparathyroidism

AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism

Start date: September 7, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics of AZP-3601 following single and repeated administration in both healthy volunteers and patients with chronic hypoparathyroidism (cHP) The protocol includes 3 parts: - Part A: first-in-human single ascending dose (SAD) study in healthy volunteers - Part B: multiple ascending dose (MAD) study with 2 weeks of treatment in healthy volunteers - Part C: open-label MAD study with a total treatment duration of 3 months in patients with cHP.

NCT ID: NCT05214274 Completed - Clinical trials for Chronic Hypoparathyroidism

Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults

PaTHwayR
Start date: January 10, 2022
Phase:
Study type: Observational

This multicenter registry study aims to understand the status of diagnosis and treatment, quality of life, medical costs and unmet medical needs of adult patients with chronic hypoparathyroidism in China.

NCT ID: NCT03878953 Withdrawn - Clinical trials for Chronic Hypoparathyroidism

A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism

Start date: August 31, 2022
Phase: Phase 3
Study type: Interventional

This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH[1-84]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.

NCT ID: NCT03425747 Completed - Clinical trials for Chronic Hypoparathyroidism

Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism

Start date: October 15, 2019
Phase: Phase 4
Study type: Interventional

Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard treatment includes oral calcium salts and active vitamin D metabolites to relieve symptoms of hypocalcaemia, maintain serum calcium levels in the low normal range and improve the patient's QoL Calcium carbonate is most often used and less expensive than other calcium preparations and contains the highest concentration of elemental calcium per gram (42%). It requires gastric hydrochloric acid to form carbonic acid (H2CO3) that immediately decomposes into water (H2O) and carbon dioxide (CO2). CO2 is responsible for its side effects such as flatulence, constipation and general gastrointestinal disorders. Therefore, in some patients it is better to find an alternative to calcium carbonate. Calcium citrate should be recommended to patients with achlorhydria or on treatment with proton pump inhibitors (PPI) as well as to patients who preferred to take supplements outside mealtimes. furthermore, patients with hypoparathyroidism have an increased risk of kidney stones. Kidney stones are formed by calcium salts, among which the most frequent ones are calcium-oxalate (70-80%), followed by calcium-phosphate and uric acid. Citrate salts are widely used in the treatmentof nephrolithiasis, since have shown an inhibitory effect on kidney stone formation. Up to now, there are no studies aimed to investigate the efficacy of calcium citrate in the management of subjects with chronic hypoparathyroidism. In particular, we will investigate if calcium citrate compared to calcium carbonate does not affect the risk of renal stones, if it is able to maintain normal calcium levels and, if it has an impact on QOL, in subjects with chronic hypoparathyroidism.

NCT ID: NCT02910466 Completed - Hypoparathyroidism Clinical Trials

A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

Start date: October 27, 2016
Phase: Phase 4
Study type: Interventional

Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhPTH(1-84) is a potential treatment option. The group of participants in the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11 years. This study is designed to extend this experience and gain knowledge about how safe and effective rhPTH(1-84) is in participants with hypoparathyroidism over a long-term duration.