Te ( DrugBank: - )
1 disease
ID | Disease name (Link within this page) | Number of trials |
---|---|---|
235 | Hypoparathyroidism | 46 |
235. Hypoparathyroidism
Clinical trials : 88 / Drugs : 128 - (DrugBank : 25) / Drug target genes : 5 - Drug target pathways : 7
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 | NCT05130476 (ClinicalTrials.gov) | October 1, 2021 | 8/11/2021 | Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Thyroidectomy | Intraoperative Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Total and Completion Thyroidectomy: a Matched Cohort Study | Hypoparathyroidism Postprocedural | Procedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography | Odense University Hospital | NULL | Recruiting | 18 Years | N/A | All | 139 | N/A | Denmark |
2 | ChiCTR2100047758 | 2021-07-01 | 2021-06-26 | A medical records based study for observation of Teriparatidec in the treatment of congenital hypoparathyroidism | The observation of Teriparatide in the treatment of congenital hypoparathyroidism | Congenital Hypoparathyroidism | Teriparatide group:No;Control group:No; | The Seventh Medical Center, PLA General Hospital | NULL | Pending | 0 | 18 | Both | Teriparatide group:5;Control group:5; | China | |
3 | EUCTR2020-003380-26-FR (EUCTR) | 15/03/2021 | 27/10/2020 | PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism. | A Phase 3, 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 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 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 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 INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleava | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
4 | NCT04750460 (ClinicalTrials.gov) | March 2021 | 2/2/2021 | Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa). | The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial | Secondary Hyperparathyroidism;Chronic Kidney Disease-Mineral and Bone Disorder;Dialysis;Hypocalcemia;Hypoparathyroidism | Drug: Teriparatide | Saint Petersburg State University, Russia | NULL | Enrolling by invitation | 18 Years | N/A | All | 20 | Phase 3 | Russian Federation |
5 | EUCTR2020-003380-26-DE (EUCTR) | 25/02/2021 | 02/11/2020 | PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism. | A Phase 3, 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 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 INN or Proposed INN: Palopegteriparatide 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 INN or Proposed INN: Palopegteriparatide 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 INN or Proposed INN: Palopegteriparatide 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-DI | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
6 | EUCTR2020-005189-32-FR (EUCTR) | 09/02/2021 | 04/12/2020 | Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy | Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy - HYPOCAAVI | Thyroidectomy total MedDRA version: 20.0;Level: LLT;Classification code 10043777;Term: Thyroidectomy total;System Organ Class: 100000004865;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Infracyanine | CHRU de Brest | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 242 | Phase 3 | France | ||
7 | EUCTR2020-003380-26-IT (EUCTR) | 21/01/2021 | 24/05/2021 | PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism. | A Phase 3, 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 - PaTHway Trial | Hypoparathyroidism 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- 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- Product Name: TransCon PTH high-dose pen Product Code: [TransCon PTH] INN or Proposed INN: Te | Ascendis Pharma Bone Disease A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | France;United States;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
8 | EUCTR2020-003380-26-HU (EUCTR) | 08/01/2021 | 02/11/2020 | PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism. | A Phase 3, 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 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 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 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 INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleava | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
9 | EUCTR2020-003380-26-DK (EUCTR) | 05/01/2021 | 20/10/2020 | PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism. | A Phase 3, 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 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 INN or Proposed INN: Palopegteriparatide 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 INN or Proposed INN: Palopegteriparatide 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 INN or Proposed INN: Palopegteriparatide 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-DI | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
10 | EUCTR2020-003380-26-NO (EUCTR) | 16/12/2020 | 26/10/2020 | PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism. | A Phase 3, 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 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 INN or Proposed INN: Palopegteriparatide 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 INN or Proposed INN: Palopegteriparatide 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 INN or Proposed INN: Palopegteriparatide 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-DI | Ascendis Pharma Bone Diseases A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | United States;France;Hungary;Canada;Denmark;Germany;Norway;United Kingdom;Italy | ||
11 | 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 | Terminated | 18 Years | N/A | All | 5 | Phase 1 | United States;Canada;Hungary |
12 | NCT04412694 (ClinicalTrials.gov) | July 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 University of Lodz | NULL | Recruiting | 18 Years | 100 Years | All | 100 | Phase 4 | Poland |
13 | 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 | ||
14 | EUCTR2018-004815-33-IT (EUCTR) | 18/11/2019 | 17/06/2021 | 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. | 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 - 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 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 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 Disease A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;United Kingdom;Italy | ||
15 | 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 | ||
16 | EUCTR2018-004815-33-NO (EUCTR) | 27/09/2019 | 20/03/2019 | 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;Norway;Italy;United Kingdom | ||
17 | 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 | ||
18 | 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 | |
19 | 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 | ||
20 | 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 | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | United States;Hungary;Canada;Denmark | ||
21 | 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 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 | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
22 | 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: 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 | 92 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
23 | 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 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 | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
24 | EUCTR2017-000284-32-IT (EUCTR) | 13/03/2018 | 31/01/2018 | 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)] - A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and M | 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 INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Trade Name: Natpara INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Trade Name: Natpara INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Trade Name: Natpara INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3;Phase 4 | United States;Portugal;France;Spain;Belgium;Denmark;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
25 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
26 | 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 | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
27 | 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 | Not Recruiting | Female: yes Male: yes | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
28 | 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 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 | Completed | 18 Years | 80 Years | All | 16 | Phase 2 | France |
29 | 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 | ||
30 | NCT04690842 (ClinicalTrials.gov) | June 2014 | 28/12/2020 | Improving Safety in Pediatric Thyroidectomy by PTH Measurements | Implementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric Patients | Hypoparathyroidism Postprocedural | Diagnostic Test: PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal) | Hospital de Niños R. Gutierrez de Buenos Aires | NULL | Completed | 2 Years | 19 Years | All | 66 | NULL | |
31 | 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 | ||
32 | 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 | |||
33 | 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 |
34 | 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 | ||
35 | 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 |
36 | 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 | ||
37 | 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 | ||
38 | 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 | |
39 | 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 | ||
40 | 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: | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom | ||
41 | 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 | ||
42 | 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 | ||
43 | 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 | Phase 4 | Denmark | ||
44 | 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 |
45 | 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 | |
46 | 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 |