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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822340
First Posted: April 2, 2013
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    The results from each month minus baseline


Enrollment: 72
Study Start Date: October 2011
Study Completion Date: February 2016
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822340


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

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01822340     History of Changes
Other Study ID Numbers: 11-HM10560A-201
First Submitted: March 25, 2013
First Posted: April 2, 2013
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Hanmi Pharmaceutical Company Limited:
AGHD

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs