Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients (HM10560A)

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Adult Growth Hormone Deficiency

Treatments: Drug: HM10560A; Drug: Genotropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01822340

11-HM10560A-201

Details and patient eligibility

About

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.

Full 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)

Enrollment: 72 patients

Sex: All

Ages: 23 to 60 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Once weekly HM10560A

Treatment:

Drug: HM10560A

Cohort 2

Experimental group

Description:

Once weekly HM10560A

Treatment:

Drug: HM10560A

Cohort 3

Experimental group

Description:

Once weekly HM10560A

Treatment:

Drug: HM10560A

Cohort 4

Experimental group

Description:

Biweekly HM10560A

Treatment:

Drug: HM10560A

Cohort 5

Active Comparator group

Description:

Once daily Genotropin

Treatment:

Drug: Genotropin