Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Phase 4

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: sustained-release recombinant human GH (SR-rhGH)

• Registration Number: NCT01605331
• Lead Sponsor: LG Life Sciences

Brief Summary

As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sustained-release recombinant human GH (SR-rhGH)	sustained-release recombinant human GH (SR-rhGH)	12-week subcutaneous administration, 2mg/week

Primary Outcome Measures

Name	Time	Method
Safety	12 weeks	Adverse event

Secondary Outcome Measures

Name	Time	Method
Efficacy	12 weeks	QoL-AGHDA