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

NCT ID: NCT01605331

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-09-30

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).

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sustained-release recombinant human GH (SR-rhGH)

12-week subcutaneous administration, 2mg/week

Group Type: EXPERIMENTAL

sustained-release recombinant human GH (SR-rhGH)

Intervention Type: DRUG

Interventions

sustained-release recombinant human GH (SR-rhGH)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LG-SHCL007

Identifier Type: -

Identifier Source: org_study_id