[Translation] A multicenter clinical trial to evaluate the efficacy and safety of recombinant human growth hormone for injection in the treatment of short stature in children caused by achondroplasia

评价注射用重组人生长激素用于因软骨发育不全所引起的儿童身材矮小的有效性和安全性的多中心临床试验。

[Translation]

A multicenter clinical trial to evaluate the efficacy and safety of recombinant human growth hormone for injection in the treatment of short stature in children caused by achondroplasia.

Start Date12 Jan 2022

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20130283

/ CompletedPhase 3

评价注射用重组人生长激素治疗特发性矮小的安全性和有效性的随机、开放、空白对照、多中心临床试验

[Translation] A randomized, open, blank-controlled, multicenter clinical trial to evaluate the safety and efficacy of recombinant human growth hormone for injection in the treatment of idiopathic short stature

1.评价注射用重组人生长激素治疗特发性矮小症的有效性 2.通过临床不良事件及实验室指标观察，以评价注射用重组人生长激素治疗特发性矮小症的安全性

[Translation]

1. To evaluate the effectiveness of recombinant human growth hormone for injection in the treatment of idiopathic dwarfism 2. To evaluate the safety of recombinant human growth hormone for injection in the treatment of idiopathic dwarfism through observation of clinical adverse events and laboratory indicators

Start Date25 Jul 2016

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20160635

/ CompletedNot Applicable

重组人生长激素注射液与注射用重组人生长激素在中国健康成年志愿者中单次给药的生物等效性研究

[Translation] Bioequivalence study of recombinant human growth hormone injection and recombinant human growth hormone for injection after single administration in healthy adult volunteers in China

评价单次给药后重组人生长激素注射液与安苏萌的主要药代动力学参数Cmax、AUC(0- t)、AUC(0-∞)的生物等效性；评价单次给药后重组人生长激素注射液与安苏萌的其他药代动力学参数的相似性及用药的安全性。

[Translation]

To evaluate the bioequivalence of the main pharmacokinetic parameters Cmax, AUC(0-t), and AUC(0-∞) of recombinant human growth hormone injection and Ansumen after a single dose; to evaluate the similarity of other pharmacokinetic parameters and the safety of recombinant human growth hormone injection and Ansumen after a single dose.

Start Date01 Jun 2016

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

100 Clinical Results associated with Human Growth Hormone (Anhui Anke)

100 Translational Medicine associated with Human Growth Hormone (Anhui Anke)

100 Patents (Medical) associated with Human Growth Hormone (Anhui Anke)

100 Deals associated with Human Growth Hormone (Anhui Anke)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Idiopathic short stature	China	Anhui Anke Biotechnology (Group) Co., Ltd.	13 Sep 2021
Growth Disorders	China	Anhui Anke Biotechnology (Group) Co., Ltd.	05 Feb 2020
Short Bowel Syndrome	China	Anhui Anke Biotechnology (Group) Co., Ltd.	05 Feb 2020
Noonan Syndrome	China	Anhui Anke Biotechnology (Group) Co., Ltd.	01 Jun 2019
Burns	China	Anhui Anke Biotechnology (Group) Co., Ltd.	01 Jan 1999
Growth hormone deficiency	China	Anhui Anke Biotechnology (Group) Co., Ltd.	01 Jan 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


S48.009 (AAN2023)	Not Applicable	Muscular Dystrophy, Facioscapulohumeral	20	Recombinant Human Growth Hormone (rHGH)	epcjijxmxy(wikyjksmrt) = 6 participants insrixfnkn (ndpcbcrqgq )	-	25 Apr 2023
ESPE2019	Not Applicable	Complication \| Proteinuria \| Hematuria rhGH \| IGF-1	169	Recombinant Human Growth Hormone	arrkgvahbn(bvyourwwmp) = In our study, 19 patients (14.3%) who underwent rhGH therapy showed renal complication such as microscopic hematuria and/or proteinuria. In patients with TS, eight (32.0%) out of 25 patients revealed renal complication. byvajlmcvj (pcowqzpfff )	Negative	19 Sep 2019
ESPE2019	Not Applicable	Complication \| Proteinuria \| Hematuria rhGH \| IGF-1	169	Recombinant Human Growth Hormone		Negative	19 Sep 2019
ESPE2019	Not Applicable	Familial Hypophosphatemic Rickets	34	Recombinant human growth hormone (rhGH)	vifglbtdsw(hzqesbtumb) = aghrcxrzbh tprevwimay (gvavplvsck, 0.9) View more	-	19 Sep 2019
ESPE2019	Not Applicable	Prader-Willi Syndrome	-	Recombinant human growth hormone (rhGH)	emjluydcuc(szdeguzelc) = lipoatrophy in both arms was observed at the 2. year of rhGH therapy sjscdhcuhj (amkhaixezw )	-	19 Sep 2019

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