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

Conditions: Adult growth hormone deficiency (AGHD)
MedDRA version: 18.0Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-001826-61-PL

Lead Sponsor: Hanmi Pharmaceutical Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 65

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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<br>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);Secondary Objective: NA;Primary end point(s): Primary efficacy endpoints: Change of IGF-I levels in function of time, and dose strengths;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 Measures