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

NCT ID: NCT01822340

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-02-29

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)

Conditions

Adult Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Once weekly HM10560A

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Once weekly HM10560A

Cohort 2

Once weekly HM10560A

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Once weekly HM10560A

Cohort 3

Once weekly HM10560A

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Once weekly HM10560A

Cohort 4

Biweekly HM10560A

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Once weekly HM10560A

Cohort 5

Once daily Genotropin

Group Type: ACTIVE_COMPARATOR

Genotropin

Intervention Type: DRUG

Once daily Genotropin

Interventions

HM10560A

Once weekly HM10560A

Intervention Type: DRUG

Genotropin

Once daily Genotropin

Intervention Type: DRUG

Other Intervention Names

LAPS-rhGH; Genotropin 5.3mg

Eligibility Criteria

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;

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hanmi Pharmaceutical

Budapest, , Hungary

Countries

Hungary

Other Identifiers

11-HM10560A-201

Identifier Type: -

Identifier Source: org_study_id