A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency

• Register: EUCTR
• Last refreshed on: 14 September 2015
• Main ID: EUCTR2011-001826-61-BG
• Date of registration: 12/09/2011
• Prospective Registration: Yes
• Primary sponsor: Hanmi Pharmaceutical Co., Ltd.
• Public title: A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency
• Scientific 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)
• Date of first enrolment: 07/02/2014
• Target sample size: 65
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001826-61
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 5

Countries of recruitment

Bulgaria, Hungary, India, Korea, Republic of, Poland, Romania, Russian Federation, Serbia, Ukraine

Contacts

• Name: Clinical Trials Info
• Affiliation: Accelsiors CRO and Consultancy Services

• Name: Clinical Trials Info
• Affiliation: Accelsiors CRO and Consultancy Services

Key inclusion & exclusion criteria

Inclusion criteria:
1.
GHDA subjects, males and females, of age between 23 and 65 years with childhood or adult onset, 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).
2.
rhGH drug naive or any registered or investigational rhGH replacement therapy was not given for more than 6 months before the screening.
3.
Patients on stable hormonal replacement therapies for deficiencies of other hypothalamo-pituitary axes must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening. Temporary adjustment of glucocorticoid replacement therapy, as appropriate,is acceptable.
4.
Screening IGF-I level of at least 1 SD (IGF-I SDS<- 1) below the mean IGF-I level standardized for age and sex according to the central laboratory reference values.
5.
Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
6.
Fertile females must agree to use appropriate contraceptive methods during the study and 20 days after the last dose of study medication.
7.
Female patients must have a negative serum pregnancy test at inclusion.
8.
Confirmed to be negative for anti rhGH antibodies at the time of screening.
9.
Willing and able to provide written informed consent prior to performing any study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
1.
Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months which has to be confirmed by computer tomography (CT) or magnetic resonance imaging (MRI) scan (with contrast) within 3 months prior to screening. (Patients with inactive remnant intracranial tumors are eligible).
2.
History of malignancy other than i) cranial tumor or leukemia causing GHD or ii) fully treated basal cell carcinoma or evidence of active malignancy.
3.
Current antitumor therapy.
4.
Subjects presenting with any clinically significant ECG abnormality.
5.
Evidence of intracranial hypertension.
6.
Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit of normal).
7.
Significant renal impairment as indicated by serum creatinine levels above the normalized range for age.
8.
Any other major medical conditions, including e.g., clinically manifest diabetes mellitus, hypertension, tuberculosis, major surgery within the last three months before screening, or significantly abnormal laboratory tests (e.g., disturbed calcium homeostasis); or any other conditions (e.g., acute infections) that may influence drug absorption, metabolism or excretion or that may interfere with any study variables in the judgment of the investigator.
9.
Systemic corticosteroids other than in replacement doses within the 3 months before screening. (Temporary adjustment of glucocorticoids, as appropriate, is acceptable).
10.
Pregnancy and breastfeeding
11.
Anabolic steroids other than gonadal steroid replacement therapy within
2 months before screening. Per-oral estrogen replacement and hormonal
contraceptives are not allowed. For replacement purposes, transdermal
estrogens are permitted in female patients.
12.
History of non-compliance with medications, un-cooperativeness or
alcohol/drug abuse.
13.
Positive results from serology examination for HBV, HCV or HIV.
14.
Known or suspected hypersensitivity to the study treatment.
15.
Blood donation or any major blood loss >500 mL within the past 90 days
prior to screening.
16.
History of any medical or psychiatric condition that in the opinion of the
investigator would pose a risk for participation in this study or interfere
with the compliance needed for this study.
17.
Received an investigational drug or product, or participated in a drug
study within 30 days before Screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Adult growth hormone deficiency (AGHD)
MedDRA version: 18.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders

Intervention(s)

Product Name: HM10560A
Product Code: HM10560A
Pharmaceutical Form: Solution for injection
Current Sponsor code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 19.5-

Trade Name: Genotropin
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629-01-5
Other descriptive name: recombinant DNA-derived human growth hormone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5.3-

Primary Outcome(s)

Main Objective: 1.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
2.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
3.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)

Primary end point(s): Primary efficacy endpoints: Change of IGF-I levels in function of time, and dose strengths

Secondary Objective: NA

Timepoint(s) of evaluation of this end point: on week 2,4,8,12,16,20,24,28,32,36,40,44,48,56,64,72,74

Secondary Outcome(s)

Secondary end point(s): Secondary efficacy endpoints:
Biochemical endpoints (IGF-I andIGFBP3 will also serve as pharmacodynamic endpoints):
Main biochemical endpoints
1)IGF-I SDS; changes to baseline in IGF-I SDS;
2)IGFBP3, IGFBP3 SDS (actual values and SDS changes to baseline)
Exploratory biochemical endpoints
1)Lipid parameters (Total Cholesterol, LDL, HDL, Lp(a) Lipoprotein, triglycerides; actual values and changes to baseline)
Clinical endpoints:
Main Clinical endpoints
1)Change in lean body mass (LBM) expressed in kg-s; from the baseline to the end of study (as measured with DXA)
2)Change in body fat mass (FM) expressed in kg-s from the baseline to the end of study as measured with DXA
3)Relative change in body fat,
4)Change in trunk fat (kg-s)
5)Relative change in trunk fat
6)Change in bone mineral density
Exploratory clinical endpoints
1)Change in waist circumference
2)Change in hip circumference
3)Change in waist-to-hip ratio
4)Change in sum of skinfolds thickness
5)Change in BMI
6)Change in QoL (SF-36) scores

Timepoint(s) of evaluation of this end point: Main biochemical endpoints on week 2,4,8,12,16,20,24,28,32,36,40,44,48,56,64,72,74
Exploratory biochemical endpoints on week 4,12,24,36,48,74
Main clinical endpoints on week 12,24,48,74
Exploratory clinical endpoints on week 12,24,48,74

Secondary ID(s)

11-HM10560A-201

2011-001826-61-HU

Source(s) of Monetary Support

Hanmi Pharmaceutical Co., Ltd.