Clinical trials: Hypoparathyroidism
Hypoparathyroidism, Endocrine System Diseases
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
During the first 26 weeks of the trial, participants were randomly assigned to one of two groups: one group received TransCon PTH and one group received placebo.
- Conditions
- Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases
- Trial name
- PaTHway (NCT04701203)
- Testing
- TransCon PTH
- Where
- 21 sites in United States, Canada and 5 more
- Volunteers
- 84 people
- Sponsor
- Ascendis Pharma Bone Diseases A/S
Down Syndrome, Edwards Syndrome
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal…
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02787486
- Testing
- Blood sampling for Laboratory Developed Test (LDT) analysis
- Where
- 8 sites in United States
- Volunteers
- 760 people
- Sponsor
- Progenity, Inc.
Hypoparathyroidism
Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as…
- Trial name
- PARALLAX (NCT02781844)
- Testing
- 25mcg rhPTH(1-84), 50mcg rhPTH(1-84), 100mcg rhPTH(1-84)
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 34 people
- Sponsor
- Shire
Pregnant Individuals, Aneuploidy
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of…
- Conditions
- Pregnant Individuals, Aneuploidy, Down Syndrome (Trisomy 21), 22q11.2 Deletion Syndrome
- Trial name
- ADVANCE (NCT07643896)
- Where
- 9 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- BillionToOne Inc.
Chronic Hypoparathyroidism
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
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)…
- Trial name
- NCT05239221
- Testing
- AZP-3601
- Where
- 2 sites in Hungary, Netherlands
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypoparathyroidism
A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism Patients
Primary objective: Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).
- Trial name
- AMCS009 (NCT01815021)
- Testing
- amorphous calcium carbonate, crystalline calcium supplements
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Amorphical Ltd.
Hypoparathyroidism
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
- Trial name
- NCT01268098
- Testing
- NPSP558
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- Shire
Hypoparathyroidism
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed…
- Trial name
- NCT07264634
- Testing
- Palopegteriparatide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ascendis Pharma A/S
Down Syndrome, Edwards Syndrome
Whole Blood Specimen Collection From Pregnant Subjects
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02430584
- Testing
- Observational - no intervention
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Progenity, Inc.
Hypoparathyroidism, Parathyroid Hormone Deficiency
PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active…
- Conditions
- Hypoparathyroidism, Parathyroid Hormone Deficiency, Endocrine System Diseases, Parathyroid Diseases
- Trial name
- NCT05387070
- Testing
- TransCon PTH
- Where
- China
- Volunteers
- 81 people
- Sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.
Hypoparathyroidism
A Registry for Participants With Chronic Hypoparathyroidism
The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) treatment in participants with chronic hypoparathyroidism under conditions of…
- Trial name
- PARADIGHM (NCT01922440)
- Testing
- No intervention
- Where
- 100 sites in United States, Austria and 9 more
- Volunteers
- 1,339 people
- Sponsor
- Takeda
Hypoparathyroidism
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult…
- Trial name
- REPEAT (NCT01455181)
- Testing
- NPSP558
- Where
- 3 sites in Hungary
- Volunteers
- 24 people
- Sponsor
- Shire
Hypoparathyroidism, Chronic Hypoparathyroidism
Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism
The aim of the study is to evaluate the efficacy, safety, and tolerability of orally administered encaleret tablets in participants with chronic hypoparathyroidism (HP).
- Trial name
- RECLAIM-HP (NCT07805356)
- Testing
- Encaleret
- Where
- 5 sites in United States, Canada
- Volunteers
- 160 people
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
Hypoparathyroidism
A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism.
- Trial name
- NCT03324880
- Testing
- rhPTH (1-84)
- Where
- 40 sites in United States, Belgium and 11 more
- Volunteers
- 93 people
- Sponsor
- Shire
Hypoparathyroidism
A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
- Trial name
- NCT01297309
- Testing
- NPSP558
- Where
- 14 sites in United States
- Volunteers
- 51 people
- Sponsor
- Shire
Complete DiGeorge Anomaly, DiGeorge Syndrome
Thymus Transplantation Safety-Efficacy
Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no thymus function, bone marrow stem cells do not develop into educated T cells, which fight infection.
- Conditions
- Complete DiGeorge Anomaly, DiGeorge Syndrome, DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- NCT01220531
- Testing
- Cultured Thymus Tissue
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Autosomal Dominant Hypocalcemia (ADH)
A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations
This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor antagonist) on activating mutations of the Calcium-sensing receptor in patients with Autosomal Dominant Hypocalcemia.
- Trial name
- NCT02204579
- Testing
- NPSP795
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Shire
Hypoparathyroidism, Endocrine System Diseases
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
This trial has a treatment duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day.
- Conditions
- Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases
- Trial name
- PaTHway60 (NCT07081997)
- Testing
- Palopegteriparatide Experimental Arm, Palopegteriparatide Control Arm
- Where
- 9 sites in United States
- Volunteers
- 36 people
- Sponsor
- Ascendis Pharma Bone Diseases A/S
Chronic Hypoparathyroidism, Hypoparathyroidism
A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhPTH(1-84) is a potential treatment option.
- Trial name
- NCT02910466
- Testing
- rhPTH(1-84)
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Shire
Hypoparathyroidism
A Single Arm Study Comparing ACC Supplement to CCS in Management of Hypoparathyroidism
Primary objective: Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).
- Trial name
- AMCS009 (NCT06288490)
- Testing
- amorphous calcium carbonate
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Amorphical Ltd.