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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01822340
First received: March 25, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Adult Growth Hormone Deficiency
Drug: HM10560A
Drug: Genotropin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Change of IGF-I levels in function of time, and dose strengths [ Time Frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months ] [ Designated as safety issue: No ]
    The results from each month minus baseline


Secondary Outcome Measures:
  • IGF-I SDS; changes to baseline in IGF-I SDS [ Time Frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months ] [ Designated as safety issue: No ]
    The results from each month minus baseline


Estimated Enrollment: 65
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Once weekly HM10560A
Drug: HM10560A
Once weekly HM10560A
Other Name: LAPS-rhGH
Experimental: Cohort 2
Once weekly HM10560A
Drug: HM10560A
Once weekly HM10560A
Other Name: LAPS-rhGH
Experimental: Cohort 3
Once weekly HM10560A
Drug: HM10560A
Once weekly HM10560A
Other Name: LAPS-rhGH
Experimental: Cohort 4
Biweekly HM10560A
Drug: HM10560A
Once weekly HM10560A
Other Name: LAPS-rhGH
Active Comparator: Cohort 5
Once daily Genotropin
Drug: Genotropin
Once daily Genotropin
Other Name: Genotropin 5.3mg

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)
  Eligibility

Ages Eligible for Study:   23 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822340

Locations
Hungary
Hanmi
Budapest, Hungary
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01822340     History of Changes
Other Study ID Numbers: 11-HM10560A-201
Study First Received: March 25, 2013
Last Updated: February 6, 2014
Health Authority: Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency

Keywords provided by Hanmi Pharmaceutical Company Limited:
AGHD

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014