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

NCT01822340 | Completed Phase 2 DMC

• 1 other identifier: 11-HM10560A-201
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Growth Hormone Deficiency

Keywords

AGHD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (5)

Cohort 1

EXPERIMENTAL

Once weekly HM10560A

Drug: HM10560A

Cohort 2

EXPERIMENTAL

Once weekly HM10560A

Drug: HM10560A

Cohort 3

EXPERIMENTAL

Once weekly HM10560A

Drug: HM10560A

Cohort 4

EXPERIMENTAL

Biweekly HM10560A

Drug: HM10560A

Cohort 5

ACTIVE COMPARATOR

Once daily Genotropin

Drug: Genotropin

Interventions

HM10560A DRUG

Once weekly HM10560A

Also known as: LAPS-rhGH

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Genotropin DRUG

Once daily Genotropin

Also known as: Genotropin 5.3mg

Cohort 5

Eligibility Criteria

• Age: 23 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi Pharmaceutical

Budapest, Hungary

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 2, 2013
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

HU (1)