DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 100mcg rhPTH(1-84); 25mcg rhPTH(1-84); 50mcg rhPTH(1-84); A: PTH (1-84); Acetate; Alfacalcidol; Amorphous calcium carbonate; Betamethasone; CLTX-305; Calcitriol; Calcitriol & Calcium; Calcium; Calcium Carbonate; Calcium Citrate; Calcium carbonate; Calcium carbonate and alphacalcidol; Calcium citrate; Calcium gluconate; Calcium lactate; Carbonate; Combination Product: TransCon PTH; Combination product (Natpara) and drug or supplements [Disease and drug registry]; Crystalline calcium supplements; Dexamethasone; Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland).; Diagnostic Test: Postoperative laboratory blood tests at 24 hour; Diagnostic Test: Postoperative laboratory blood tests at 6 hour; Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour; Diagnostic Test: Preoparative blood laboratory tests; EB612 (EBP05); ESIDREX-R; ESIDREX-R 25 mg; EnteraBio's Oral Parathyroid Hormone (1-34); Esidrex; Ether; FORSTEO; FORSTEO-R; Forsteo; Human recombinant parathyroid Hormone; Human recombinant parathyroid hormone; Hydrochlorothiazide; INDOCYANINE GREEN; INN Parathyroid Hormone (1-84) human; Immediate post operative bioassay of Parathyroid Hormone; Indocyanine Green; Indocyanine green; Magnesium; NATPARA/NATPAR; NPSP 558; NPSP558; Natpar; Natpara; Open-label PTH(1-84); Other: Empiric use of Calcium Carbonate and Calcitriol; Other: PTH based Calcium Carbonate and Calcitriol repletion; Other: Postoperative nausea and vomiting at 24 hour; Other: Postoperative nausea and vomiting at 6 hour; Other: Postoperative pain at 24 hour; Other: Postoperative pain at 6 hour; Other: Postoperative sore throat and hoarseness at 24 hour; Other: Postoperative sore throat and hoarseness at 6 hour; Other: Serum calcium concentrations results; Other: Symptomatic hypocalcaemia at 24 hour; Other: Symptomatic hypocalcaemia at 6 hour; PARATHYROID HORMONE; PCO371; POLY(OXY-1,2-ETHANEDIYL), A; 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); PREOTACT; PTH; PTH 1-34; PTH1-84 in parent study; Parathyroid; Parathyroid Hormone; Parathyroid Hormone (1-84) Human Recombinant; Parathyroid Hormone (rDNA); Parathyroid hormon 1-84; Parathyroid hormone; Parathyroid hormone (rdna); Parathyroideahormon; Phosphate; Phosphate and betamethasone acetate, 2 mL.; Polyethylene glycol; Potassium; Potassium sparing diuretic; Preotact; Procedure: Total thyroidectomy; RECOMBINANT HUMAN PARATHYROID HORMONE (1-84); Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]; Recombinant Human Parathyroid Hormone [rhPTH(1-84)]; RhPTH; RhPTH (1-84); RhPTH(1-84); SUB21634; Saline 0.9% NaCl; Sevelamer; Sodium citrate; Synthetic Human Parathyroid Hormone 1-34; TERIPARATIDE; Teriparatide; Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker; Thiazide; Thymus/Parathyroid Transplantation; TransCon PTH; TransCon PTH high-dose pen; TransCon PTH low-dose pen; TransCon PTH mid-dose pen; Tériparatide; UN-ALPHA-R; UN-ALPHA-R 0.25µg; Verde de Indocianina (Indocyanine Green); Vitamin D

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	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
2	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
3	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
4	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

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

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

Phase 2

United States;Canada;Denmark;Germany;United Kingdom

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

Phase 2

United States;Canada;Denmark;Germany;Italy;Norway;United Kingdom

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.

Ascendis Pharma Bone Diseases A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Denmark;Germany;United Kingdom

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.

Ascendis Pharma Bone Diseases A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Denmark;Germany