235. 副甲状腺機能低下症
［臨床試験数：67，薬物数：112（DrugBank：24），標的遺伝子数：4，標的パスウェイ数：5］
Searched query = "Hypoparathyroidism", "Accessory thyroid hypergasia disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-194828 | 31/3/2021 | 25/06/2019 | A Clinical Study of rhPTH (1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism | A Phase 3, Open-label Clinical Study of rhPTH (1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism | Chronic Hypoparathyroidism | Intervention name : rhPTH (1-84) INN of the intervention : Parathyroid hormone Dosage And administration of the intervention : rhPTH (1-84) will be administered at 25, 50, 75 and 100 micrograms once daily in one of the thighs (alternate thigh every day) as a subcutaneous injection. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | pending | 20 | 85 | BOTH | 12 | Phase 3 | Japan |
| 2 | NCT03878953 (ClinicalTrials.gov) | March 31, 2021 | 15/3/2019 | A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism | A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism | Chronic Hypoparathyroidism | Drug: rhPTH(1-84) | Shire | NULL | Not yet recruiting | 20 Years | 85 Years | All | 12 | Phase 3 | Japan |
| 3 | NCT04412694 (ClinicalTrials.gov) | September 1, 2020 | 23/5/2020 | The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients. | The Impact of Preoperative Oral Dexamethasone Supplementation on the Biochemical Parameters and Results of Surgical Treatment in Patients With Nontoxic Multinodular Goiter Undergoing Total Thyroidectomy. | Hypocalcemia;Vitamin D Deficiency;Postoperative Complications;Postoperative Nausea;Postoperative Pain;Voice Hoarseness;Hypoparathyroidism Postprocedural | Drug: Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland).;Drug: Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria).;Diagnostic Test: Preoparative blood laboratory tests;Diagnostic Test: Postoperative laboratory blood tests at 6 hour;Diagnostic Test: Postoperative laboratory blood tests at 24 hour;Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour;Procedure: Total thyroidectomy;Other: Symptomatic hypocalcaemia at 6 hour;Other: Symptomatic hypocalcaemia at 24 hour;Other: Postoperative pain at 6 hour;Other: Postoperative pain at 24 hour;Other: Postoperative nausea and vomiting at 6 hour;Other: Postoperative nausea and vomiting at 24 hour;Other: Postoperative sore throat and hoarseness at 6 hour;Other: Postoperative sore throat and hoarseness at 24 hour | Medical Universtity of Lodz | NULL | Recruiting | 18 Years | 100 Years | All | 100 | Phase 4 | Poland |
| 4 | NCT04209179 (ClinicalTrials.gov) | July 23, 2020 | 28/11/2019 | A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism | A Randomized, Double-Blind, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PCO371 in Patients With Hypoparathyroidism | Hypoparathyroidism | Drug: PCO371;Drug: Placebo | Chugai Pharmaceutical | NULL | Recruiting | 18 Years | N/A | All | 24 | Phase 1 | United States;Canada;Hungary |
| 5 | NCT04465227 (ClinicalTrials.gov) | July 15, 2020 | 9/7/2020 | Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX-305 in Autosomal Dominant Hypocalcemia Type 1 (ADH1) | A Phase IIb, Open-label Dose-ranging Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX Hypocalcemia Type l (ADHl). | Hypoparathyroidism | Drug: CLTX-305 | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Not yet recruiting | 16 Years | N/A | All | 20 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2019-003506-26-ES (EUCTR) | 05/03/2020 | 14/01/2020 | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy | Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green to predict the possible occurrence of postoperative hypocalcemia MedDRA version: 20.1;Level: LLT;Classification code 10020949;Term: Hypocalcemia;System Organ Class: 100000004861 MedDRA version: 20.0;Classification code 10043777;Term: Thyroidectomy total;System Organ Class: 100000004865 MedDRA version: 21.0;Level: PT;Classification code 10080819;Term: Post procedural hypoparathyroidism;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Verde de Indocianina (Indocyanine Green) Product Name: Indocyanine Green INN or Proposed INN: Indocyanine green Other descriptive name: INDOCYANINE GREEN | Hospital Universitari Son Espases | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Spain | ||
| 7 | NCT03425747 (ClinicalTrials.gov) | October 15, 2019 | 27/1/2018 | Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism | CALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISM | Chronic Hypoparathyroidism | Drug: Calcium Carbonate;Drug: Calcium Citrate | Campus Bio-Medico University | NULL | Completed | 18 Years | 75 Years | All | 26 | Phase 4 | Italy |
| 8 | EUCTR2018-004815-33-GB (EUCTR) | 08/10/2019 | 06/02/2020 | PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism. | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward | Hypoparathyroidism (HP) in Adults MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon PTH low-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1) Product Name: TransCon PTH mid-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1) Product Name: TransCon PTH high-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;United Kingdom | ||
| 9 | NCT04009291 (ClinicalTrials.gov) | August 27, 2019 | 20/6/2019 | A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism | PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism | Hypoparathyroidism;Endocrine System Diseases;Parathyroid Diseases | Combination Product: TransCon PTH;Combination Product: Placebo for TransCon PTH | Ascendis Pharma A/S | NULL | Active, not recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States;Canada;Denmark;Germany;Italy;Norway;United Kingdom |
| 10 | EUCTR2018-004815-33-DK (EUCTR) | 05/07/2019 | 27/05/2019 | PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism. | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward | Hypoparathyroidism (HP) in Adults MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon PTH low-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1) Product Name: TransCon PTH mid-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1) Product Name: TransCon PTH high-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), A | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT04126941 (ClinicalTrials.gov) | June 1, 2019 | 11/10/2019 | Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism | Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience | Hypoparathyroidism | Other: Serum calcium concentrations results | Hospices Civils de Lyon | NULL | Recruiting | 2 Years | 18 Years | All | 9 | France | |
| 12 | ChiCTR1900022194 | 2019-04-02 | 2019-03-30 | A prospective randomized controlled trial of different calcium supplementation regimens on the recovery of parathyroid function after thyroid surgery | A prospective randomized controlled trial of different calcium supplementation regimens on the recovery of parathyroid function after thyroid surgery | Hypoparathyroidism | Prophylactic group:Prophylactic calcium and vitamin D supplementation;treatment group:calcium and vitamin Dsupplementation is appropriate for hypocalcemia symptomatic patients; | West China Hospital, Sichuan University | NULL | Recruiting | 18 | 75 | Both | Prophylactic group:150;treatment group:150; | N/A | China |
| 13 | NCT03364738 (ClinicalTrials.gov) | September 26, 2018 | 20/11/2017 | Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism | An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With Hypoparathyroidism | Hypoparathyroidism | Biological: rhPTH(1-84) | Shire | NULL | Completed | 18 Years | N/A | All | 22 | Phase 3 | United States;Canada;Denmark;Hungary |
| 14 | EUCTR2017-003067-36-DK (EUCTR) | 08/08/2018 | 08/06/2018 | A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | Denmark;United States;Hungary;Canada | ||
| 15 | EUCTR2017-003067-36-HU (EUCTR) | 28/06/2018 | 25/04/2018 | A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 3 | United States;Hungary;Canada;Denmark | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03516773 (ClinicalTrials.gov) | June 17, 2018 | 23/4/2018 | Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism | An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Parathyroid Hormone [PTH (1-34)] and NATPARA® in Patients With Hypoparathyroidism | Hypoparathyroidism | Drug: EB612 (EBP05);Drug: NATPARA/NATPAR | Entera Bio Ltd. | NULL | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | Israel |
| 17 | EUCTR2017-000284-32-NL (EUCTR) | 04/06/2018 | 01/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;France;United States;Belgium;Spain;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 18 | EUCTR2017-000284-32-PT (EUCTR) | 02/04/2018 | 16/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | France;United States;Portugal;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 19 | EUCTR2017-000284-32-BE (EUCTR) | 30/03/2018 | 18/12/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;France;United States;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 20 | NCT03324880 (ClinicalTrials.gov) | February 15, 2018 | 10/10/2017 | Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With Hypoparathyroidism | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism | Biological: rhPTH(1-84);Biological: Placebo | Shire | NULL | Recruiting | 18 Years | 85 Years | All | 150 | Phase 4 | United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2017-000284-32-GB (EUCTR) | 05/02/2018 | 27/10/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | United States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 22 | EUCTR2017-000284-32-SE (EUCTR) | 18/01/2018 | 02/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 23 | EUCTR2017-000284-32-DK (EUCTR) | 10/01/2018 | 09/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 24 | NCT03249012 (ClinicalTrials.gov) | September 1, 2017 | 9/8/2017 | Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism | Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism | Hypoparathyroidism Postprocedural;Quality of Life | Other: Empiric use of Calcium Carbonate and Calcitriol;Other: PTH based Calcium Carbonate and Calcitriol repletion | CHU de Quebec-Universite Laval | NULL | Recruiting | 18 Years | N/A | All | 120 | N/A | Canada |
| 25 | NCT02824718 (ClinicalTrials.gov) | June 6, 2017 | 1/7/2016 | Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism | A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism | Autosomal Dominant Hypocalcemia or OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment | Drug: Teriparatide;Drug: Thiazide;Drug: Potassium sparing diuretic;Drug: Alfacalcidol | Assistance Publique - Hôpitaux de Paris | Ministry of Health, France | Recruiting | 18 Years | 80 Years | All | 12 | Phase 2 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03150108 (ClinicalTrials.gov) | May 16, 2017 | 1/5/2017 | Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects | A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese Subjects | Hypoparathyroidism | Drug: rhPTH(1-84) | Shire | NULL | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States |
| 27 | NCT02781844 (ClinicalTrials.gov) | April 3, 2017 | 19/4/2016 | 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 | An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism | Hypoparathyroidism | Drug: 25mcg rhPTH(1-84);Drug: 50mcg rhPTH(1-84);Drug: 100mcg rhPTH(1-84) | Shire | NULL | Completed | 18 Years | N/A | All | 34 | Phase 1 | United States;Canada;Denmark;Hungary |
| 28 | NCT04146259 (ClinicalTrials.gov) | January 1, 2017 | 29/10/2019 | Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism | Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism | Hypoparathyroidism Postprocedural | Drug: calcium carbonate and alphacalcidol | University of Athens | NULL | Completed | 19 Years | N/A | Female | 109 | Greece | |
| 29 | NCT02910466 (ClinicalTrials.gov) | December 9, 2016 | 20/9/2016 | A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism | A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism | Chronic Hypoparathyroidism;Hypoparathyroidism | Drug: rhPTH(1-84) | Shire | NULL | Completed | 18 Years | 85 Years | All | 36 | Phase 4 | United States |
| 30 | NCT04012476 (ClinicalTrials.gov) | November 2016 | 28/6/2019 | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy | Hypocalcemia;Total Thyroidectomy;Hypoparathyroidism Postprocedural | Drug: Indocyanine Green | Hospital Son Espases | Universitat de les Illes Balears | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2016-000500-29-FR (EUCTR) | 03/06/2016 | 26/04/2016 | A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia | A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia - ACTICAS | Autosomal dominant hypocalcemia (ADH) MedDRA version: 19.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: FORSTEO-R Product Name: FORSTEO-R INN or Proposed INN: Tériparatide Other descriptive name: FORSTEO-R Trade Name: ESIDREX-R 25 mg Product Name: ESIDREX-R 25 mg INN or Proposed INN: Hydrochlorothiazide Other descriptive name: ESIDREX-R Trade Name: UN-ALPHA-R 0.25µg Product Name: UN-ALPHA-R 0.25µg INN or Proposed INN: Alfacalcidol Other descriptive name: UN-ALPHA-R | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | France | ||
| 32 | NCT02986607 (ClinicalTrials.gov) | March 2016 | 5/12/2016 | Corticosteroid Rhythms in Hypoparathyroid Patients | Corticosteroid Rhythms in Hypoparathyroid Patients | Hypoparathyroidism;Hyperparathyroidism | Drug: parathyroid hormon 1-84 | University of Bergen | Haukeland University Hospital | Recruiting | 18 Years | 60 Years | All | 30 | Early Phase 1 | Norway |
| 33 | NCT02652884 (ClinicalTrials.gov) | January 2016 | 5/1/2016 | Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy | Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy | Transient Hypoparathyroidism | Drug: phosphate and betamethasone acetate, 2 mL.;Drug: saline 0.9% NaCl | Hospital Italiano de Buenos Aires | NULL | Recruiting | 18 Years | N/A | Both | 110 | Phase 4 | Argentina |
| 34 | EUCTR2015-003108-22-GB (EUCTR) | 08/12/2015 | 26/10/2015 | Study on parathyroid hormone for use in hypoparathyroidism in children 12 to less than 18 years old. | An Open-label, Single-dose Study to Determine the Pharmacokinetic/Pharmacodynamic Profile of Parathyroid Hormone (rDNA) Administered Subcutaneously at a Dose of50 µg in Subjects with Hypoparathyroidism Who Are 12 to LessThan 18 Years of Age | Chronic hypoparathyroidism;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Parathyroid Hormone (rDNA) Product Code: NPSP 558 INN or Proposed INN: INN Parathyroid Hormone (1-84) human Other descriptive name: Parathyroid Hormone (1-84) Human Recombinant | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | United Kingdom | ||
| 35 | NCT02152228 (ClinicalTrials.gov) | July 2014 | 22/4/2014 | A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism | A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism | Hypoparathyroidism | Drug: EnteraBio's Oral Parathyroid Hormone (1-34) | Entera Bio Ltd. | NULL | Completed | 18 Years | 80 Years | Both | 20 | Phase 2 | Israel |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2013-001890-26-IT (EUCTR) | 06/05/2014 | 27/03/2014 | Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism | Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism | Refractory hypoparathyroidism MedDRA version: 16.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: FORSTEO Product Name: FORSTEO INN or Proposed INN: TERIPARATIDE | Dipartimento di Medicina e Chirurgia Traslazionale dell’Università degli Studi di Firenze | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Italy | ||
| 37 | NCT01922440 (ClinicalTrials.gov) | July 1, 2013 | 1/8/2013 | A Registry for Participants With Chronic Hypoparathyroidism | PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism | Chronic Hypoparathyroidism | Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry] | Shire | NULL | Recruiting | N/A | N/A | All | 900 | United States;Austria;Canada;Denmark;Germany;Norway;Sweden | |
| 38 | NCT01815021 (ClinicalTrials.gov) | April 2013 | 7/3/2013 | A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism Patients | A Randomized, Two Phase, Adaptive Then Crossover Open-label, Study Comparing Amorphous Calcium Carbonate (ACC) Supplement Versus Commercially Available Crystalline Calcium Supplements (CCS) in the Management of Primary Hypoparathyroidism. | Hypoparathyroidism | Dietary Supplement: amorphous calcium carbonate;Dietary Supplement: crystalline calcium supplements | Amorphical Ltd. | NULL | Completed | 18 Years | 80 Years | Both | 10 | Phase 1;Phase 2 | Israel |
| 39 | NCT02924532 (ClinicalTrials.gov) | February 2012 | 13/9/2016 | Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy | Diagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational Study | Hypoparathyroidism | Biological: immediate post operative bioassay of Parathyroid Hormone | Centre Hospitalier Universitaire de Nimes | NULL | Completed | 18 Years | N/A | Both | 300 | N/A | NULL |
| 40 | NCT01455181 (ClinicalTrials.gov) | August 19, 2011 | 15/9/2011 | A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary | A 6-Month 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 | Hypoparathyroidism | Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 24 | Phase 3 | Hungary |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2011-001265-40-HU (EUCTR) | 29/07/2011 | 23/05/2011 | A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with Hypoparathyroidism | A 6-Month 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 - Not applicable | Hypoparathyroidism MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Hungary | |||
| 42 | NCT01297309 (ClinicalTrials.gov) | April 6, 2011 | 11/2/2011 | 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) | A Long-term 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) | Hypoparathyroidism | Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 51 | Phase 3 | United States |
| 43 | NCT01268098 (ClinicalTrials.gov) | January 2011 | 28/12/2010 | Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY) | A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism | Hypoparathyroidism | Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 42 | Phase 3 | United States |
| 44 | EUCTR2008-005063-34-LT (EUCTR) | 29/11/2010 | 16/08/2010 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.0;Level: PT;Classification code 10021041;Term: | Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 45 | NCT01171690 (ClinicalTrials.gov) | November 2010 | 27/7/2010 | Teriparatide for Postsurgical Hypoparathyroidism | Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism | Hypoparathyroidism Post-surgical | Drug: Teriparatide | Mayo Clinic | NULL | Terminated | 18 Years | 80 Years | All | 5 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2008-005063-34-HU (EUCTR) | 27/09/2010 | 04/10/2010 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 47 | NCT00856401 (ClinicalTrials.gov) | September 2010 | 4/3/2009 | ADD-ON Study to Existing Hypoparathyroidism Studies | Phase II Trial of Parathyroid Hormone for the Treatment of Hypoparathyroidism | Hypoparathyroidism | Drug: PTH1-84 in parent study | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Active, not recruiting | 18 Years | 85 Years | All | 62 | Phase 3 | United States |
| 48 | NCT01199614 (ClinicalTrials.gov) | December 2009 | 9/9/2010 | HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism | HEXT: The Hypoparathyroidism Studies, EXTended: The Effect of PTH on the Skeleton in Hypoparathyroidism | Hypoparathyroidism | Drug: open-label PTH(1-84) | John P. Bilezikian | NPS Pharma;Shire | Active, not recruiting | 18 Years | 85 Years | All | 75 | Phase 3 | United States |
| 49 | EUCTR2008-005063-34-FR (EUCTR) | 14/09/2009 | 14/11/2008 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 9.1;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 50 | JPRN-UMIN000002155 | 2009/09/01 | 06/07/2009 | Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy | Postoperative hypoparathyroidism | In the first day after operation, we start administration of falecalcitriol at a dosage of 0.6ug once a day, when below the lower limit of serum calcium. If serum calcium level do not reach normal range, we escalete to 0.9ug/day.Oral calcium lactate is administered 3g/day in all enrolled patients.The dose is reduced when serum calcium and intact PTH level are maintained within normal range. If subjective symptoms such as tetany are worsen up, we start administration of calcium via DIV. | kawasaki medicak school | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 30 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2008-005063-34-DK (EUCTR) | 27/08/2009 | 17/11/2008 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.0;Level: PT;Classification code 10021041;Term: | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 52 | EUCTR2008-005063-34-GB (EUCTR) | 04/08/2009 | 22/05/2009 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.0;Level: PT;Classification code 10021041;Term: | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom | |||
| 53 | EUCTR2008-005063-34-IT (EUCTR) | 27/04/2009 | 18/06/2009 | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040 | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040 | Hypoparatthyroidism MedDRA version: 12.0;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism | Product Code: NPSP 558 Product Code: NPSP 558 Product Code: NPSP 558 | NPS PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 54 | NCT00824226 (ClinicalTrials.gov) | January 2009 | 15/1/2009 | Magnesium Treatment in Hypoparathyroidism | Effect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid Patients | Hypoparathyroidism | Dietary Supplement: magnesium | University of Tartu | NULL | Completed | 18 Years | N/A | Both | 10 | N/A | Estonia |
| 55 | NCT00732615 (ClinicalTrials.gov) | December 2008 | 8/8/2008 | Use of NPSP558 in the Treatment of Hypoparathyroidism | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism | Hypoparathyroidism | Drug: Placebo;Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 124 | Phase 3 | United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2008-005063-34-BE (EUCTR) | 18/11/2008 | 18/11/2008 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 12.0;Level: PT;Classification code 10021041;Term: | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Lithuania;Denmark;Italy;United Kingdom;France;Hungary;Belgium | ||
| 57 | NCT00743782 (ClinicalTrials.gov) | August 22, 2008 | 28/8/2008 | Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism | Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism | Hypoparathyroidism;Hypocalcemia | Drug: Synthetic Human Parathyroid Hormone 1-34 | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | 7 Years | 70 Years | All | 24 | Early Phase 1 | United States |
| 58 | NCT00730210 (ClinicalTrials.gov) | June 2008 | 4/8/2008 | Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life | Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life | Hypoparathyroidism | Drug: a: PTH (1-84);Drug: b:placebo | University of Aarhus | NULL | Completed | 25 Years | 80 Years | Both | 62 | Phase 2 | Denmark |
| 59 | EUCTR2008-000606-36-DK (EUCTR) | 07/04/2008 | 25/03/2008 | Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT | Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT | Hypoparathyroidism MedDRA version: 9.1;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism | Trade Name: Preotact Product Name: parathyroid hormone (rdna) Product Code: SUB21634 INN or Proposed INN: Parathyroideahormon | Aarhus University Hospital, Dept of Endocrinology and Metabolism C | NULL | Not Recruiting | Female: yes Male: yes | 60 | Denmark | |||
| 60 | NCT00395538 (ClinicalTrials.gov) | October 30, 2006 | 2/11/2006 | Effects of PTH Replacement on Bone in Hypoparathyroidism | Effects of PTH Replacement on Bone in Hypoparathyroidism | Hypoparathyroidism;DiGeorge Syndrome | Drug: PTH 1-34 | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Terminated | 18 Years | 70 Years | All | 46 | Phase 3 | United States;Austria;Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | JPRN-UMIN000000475 | 2006/07/01 | 01/09/2006 | Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration | Relative hypoparathyoidism in maintenance hemodialysis patients | Replacement of calcium carbonate with sevelamer hydrochloride as phosphate binder | Hokusetsu ROD Study Group | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| 62 | NCT00566488 (ClinicalTrials.gov) | January 2005 | 30/11/2007 | Parathyroid and Thymus Transplantation in DiGeorge #931 | Parathyroid and Thymus Transplantation in DiGeorge Syndrome, #931 | DiGeorge Syndrome;Hypoparathyroidism;Complete DiGeorge Syndrome | Biological: Thymus/Parathyroid Transplantation | M. Louise Markert | Food and Drug Administration (FDA);National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);Enzyvant Therapeutics GmbH | Completed | N/A | 24 Months | All | 25 | Phase 1 | United States |
| 63 | NCT00581828 (ClinicalTrials.gov) | January 2005 | 19/12/2007 | Does Treatment of Hypovitaminosis D Increase Calcium Absorption? | Does Treatment of Hypovitaminosis D Increase Calcium Absorption? | Osteoporosis;Osteopenia;Vitamin D Deficiency;Hypoparathyroidism;Hypercalciuria;Hypercalcemia | Drug: Vitamin D | University of Wisconsin, Madison | NULL | Completed | N/A | N/A | Female | 19 | Phase 4 | United States |
| 64 | NCT00473265 (ClinicalTrials.gov) | May 2004 | 14/5/2007 | Bone Properties in Hypoparathyroidism: Effects of PTH | Bone Properties in Hypoparathyroidism: Effects of PTH | Hypoparathyroidism | Drug: PTH | John P. Bilezikian | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | N/A | All | 68 | Phase 2;Phase 3 | United States |
| 65 | NCT00004361 (ClinicalTrials.gov) | July 1995 | 18/10/1999 | Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects | Hypoparathyroidism;Tetralogy of Fallot;Pulmonary Valve Stenosis;Conotruncal Cardiac Defects;Heart Defects, Congenital;Pulmonary Atresia | Drug: calcium gluconate;Drug: sodium citrate | National Center for Research Resources (NCRR) | Ann & Robert H Lurie Children's Hospital of Chicago | Completed | 18 Years | N/A | Both | 150 | N/A | NULL | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT00001304 (ClinicalTrials.gov) | October 1991 | 3/11/1999 | Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 | Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 | Hypoparathyroidism | Drug: Synthetic Human Parathyroid Hormone 1-34;Drug: Calcitriol & Calcium | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | 17 Years | 69 Years | All | 27 | Phase 2 | United States |
| 67 | EUCTR2018-004815-33-DE (EUCTR) | 28/03/2019 | PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism. | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward | Hypoparathyroidism (HP) in Adults MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon PTH low-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1) Product Name: TransCon PTH mid-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1) Product Name: TransCon PTH high-dose pen Product Code: TransCon PTH INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany |