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

LG Life Sciences

Status and phase: Completed; Phase 4

Conditions: Growth Hormone Deficiency

Treatments: Drug: sustained-release recombinant human GH (SR-rhGH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01605331

LG-SHCL007

Details and patient eligibility

About

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).

Enrollment: 132 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

sustained-release recombinant human GH (SR-rhGH)

Experimental group

Description:

12-week subcutaneous administration, 2mg/week

Treatment:

Drug: sustained-release recombinant human GH (SR-rhGH)