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Register:	ChiCTR
Last refreshed on:	16 July 2018
Main ID:	ChiCTR1800017144
Date of registration:	2018-07-13
Prospective Registration:	Yes
Primary sponsor:	The Children's Hospital, Zhejiang University School of Medicine
Public title:	A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children
Scientific title:	A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children
Date of first enrolment:	2018-07-25
Target sample size:	Two groups:900;
Recruitment status:	Recruiting
URL:	http://www.chictr.org.cn/showproj.aspx?proj=28360
Study type:	Interventional study
Study design:	Dose comparison
Phase:	Post-market

Countries of recruitment
China‘

Contacts

Name:	Zhang Li
Address:	3333 Binsheng Road, Hangzhou, Zhejiang, China
Telephone:	+86 13777457849
Email:	lizoe@zju.edc.cn
Affiliation:	The Children's Hospital ,Zhejiang University School of Medicine

Name:	Junfen Fu
Address:	3333 Binsheng Road, Hangzhou, Zhejiang, China
Telephone:	+86 13777457849
Email:	fjf68@qq.com
Affiliation:	The Children's Hospital ,Zhejiang University School of Medicine

Key inclusion & exclusion criteria

Inclusion criteria: growth hormone deficiency children with Pegylated Somatropin treatment
Exclusion criteria: 1. without medication diary card;
2. without compliance to the protocol.

Age minimum: 3
Age maximum: 14
Gender: Both

Health Condition(s) or Problem(s) studied

Growth hormone deficiency

Intervention(s)

Two groups:low dose versus high dose of Pegylated Somatropin;

Primary Outcome(s)

Height standard deviation;

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

GeneScience Pharmaceutical Co.Ltd, self-financing

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 25/04/2018
Contact:

zuchiec@163.com

Huimin Yu

+86 0571-86670076

zuchiec@163.com

Results

Results available:
Date Posted:
Date Completed:
URL:

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