Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone.
- Conditions
- Growth deficiency due to growth hormone deficiencyMedDRA version: 18.1Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2016-000446-56-Outside-EU/EEA
- Lead Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 94
Children aged 4 years and 13 years (for girls) and 14 years (for boys);
Children prepubertal (Tanner stage 1); Bone age less than 11 years (for
boys) and 9 years (for girls), documented by radiographs of the hand
and wrist (will accept a radiograph performed within 6 months prior to
enrollment in the study); Naïve children with growth hormone; Children
diagnosed with disturbance in growth due to deficiency of growth
hormone documented before initial treatment with r-hGH through: The
height z score <-2.0 SD for age and sex; A response to a test stimulus
GH release with peak blood 7 ng / ml in the presence of abnormalities
morphostructural hypothalamic-pituitary region shown by Nuclear
Magnetic Resonance (NMR) or; response to stimulus two tests of GH
release with peak 7 ng / ml in the presence of a normal NMR
(stimulating agents are acceptable insulin, clonidine, glucagon,
arginine and L-dopa). Historical values of GH in blood up to 12 months
prior to enrollment in the study will be acceptable. An MRI performed
up to 2 years before inclusion in the study is acceptable; History of
growth velocity below the mean for the normal population for at least 6
months prior to inclusion in the study, according to the table of VC
Tanner (must be historical height data with a minimum of 6 months
and maximum of 18 months. Researcher must ensure that the
measurements were performed in a standardized way in standard
stadiometer (rigid deck and rigid ruler); Baseline IGF-I -0.5 SD for age
and sex (results provided by the central laboratory).
Are the trial subjects under 18? yes
Number of subjects for this age range: 94
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Children aged <4 years; Children with clinical signs of puberty (breast
/ genitalia and pubic hair Tanner stage 2); Note: Children who enterpuberty during treatment (breast development Tanner 2 / or testicles 4
ml or 2.5 cm in greatest diameter) shall be excluded; Other causes of
disorder in children including growth in stature for gestational age
(SGA), Turner syndrome, Prader-Willi syndrome, other causes; Children
with closed epiphyses bone; Children with physical changes that
prevent accurate measurement of height; Children with comorbidities
that prevent normal growth. Patients with central hypothyroidism may
be included, if well controlled with l-thyroxine, evidenced by normal
free T4 dosages; dysmorphic syndrome; Presence of signs of skeletal
dysplasia; Evidence of active malignancy or with less than two years of
treatment considered curative; uncontrolled growth of benign
intracranial tumors; Children with benign intracranial hypertension;
Children with clinical evidence of malnutrition considered relevant to
the discretion of the investigator; Children with Diabetes mellitus type
1 or 2; severe acute disease, including complications after heart
surgery by thoracotomy, abdominal surgery, multiple accidental trauma
or acute respiratory failure; concomitant chronic disease which may
interfere with the analysis of the study (eg, hyperthyroidism /
uncontrolled hypothyroidism, gastrointestinal diseases, cardiorespiratory
diseases, liver failure, kidney failure, bone pathologies that
can affect the growth, chronic inflammatory diseases and inborn errors
of metabolism); Patients with hormone deficiency related diseases by
panhypopituitarism may be included if properly controlled; MRI
findings that may interfere with the study drug (examples: intracranial
hypertension, tumors in the hypothalamic-pituitary region); Children
with anti-GH antibodies;
Children undergoing treatment for the disorder or attention deficit
hyperactivity disorder deficit hyperactivity disorder; Concomitant
medication that could influence the secretion of growth (eg, estrogen,
androgen, anabolic steroids, steroids, aromatase inhibitors) hormone.
Physiological doses of corticosteroids for the treatment of pituitary
deficiency are allowed as well as low-dose inhaled and / or nasal
steroids for the treatment of asthma or chronic rhinitis (500mcg or less
/ day beclomethasone or equivalent); or known allergy to the study
medications, or any of the excipients or thinner / solvent
hypersensitivity; Participation in another clinical study within 3 months
before study entry; Statement of legal limitation disability or parent /
legal representative
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method