Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients

A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01822340

Acronym

HM10560A

Enrollment

Registered

2013-04-02

Start date

2011-10-31

Completion date

2016-02-29

Last updated

2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Growth Hormone Deficiency

Keywords

AGHD

Brief summary

The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.

Detailed description

* To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment * To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)

Interventions

DRUGGenotropin

Once daily Genotropin

DRUGHM10560A

Once weekly HM10560A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Years to 60 Years

Healthy volunteers

Inclusion criteria

* GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009); * r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening. * Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2. * Female patients must have a negative serum pregnancy test at inclusion. * Confirmed to be negative for anti r-hGH antibodies at the time of screening. * Willing and able to provide written informed consent prior to performing any study procedures.

Exclusion criteria

* Patients with childhood onset of GHD treated with r-hGH before the age of 18. * Current antitumor therapy. * Subjects presenting with any clinically significant ECG abnormality. * Evidence of intracranial hypertension. * Significant hepatic dysfunction (persistent elevation of alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \>1.5 x upper limit of normal). * Pregnancy and breastfeeding;

Design outcomes

Primary

Measure	Time frame	Description
Change of IGF-I levels in function of time, and dose strengths	baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months	The results from each month minus baseline

Secondary

Measure	Time frame	Description
IGF-I SDS; changes to baseline in IGF-I SDS	baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months	The results from each month minus baseline

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026