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

Adult Growth Hormone Deficiency Clinical Trial

— HM10560A  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822340
• Other study ID #: 11-HM10560A-201
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2013
• Last updated: February 17, 2016
• Start date: October 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 60 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases

Intervention

Drug:
• HM10560A
Once weekly HM10560A
• Genotropin
Once daily Genotropin

Locations

Country	Name	City	State
Hungary	Hanmi Pharmaceutical	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of IGF-I levels in function of time, and dose strengths	The results from each month minus baseline	baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months	No
Secondary	IGF-I SDS; changes to baseline in IGF-I SDS	The results from each month minus baseline	baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months	No