Clinical study to compare recombinant human growth hormone Cristália (r-hGH Cristália) versus Genotropin® pre puberty in children with failure to thrive due to deficiency of growth hormone.

Phase 3

• Conditions: Growth deficiency due to growth hormone deficiency; M89.2

• Registration Number: RBR-85bbp4
• Lead Sponsor: ICF - Instituto de Ciências Farmaceuticas de Estudos e Pesquisas LTDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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).

Exclusion Criteria

Children aged <4 years; Children with clinical signs of puberty (breast / genitalia and pubic hair Tanner stage 2); Note: Children who enter puberty 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, cardio-respiratory 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: Intervention
• Study Design: Not specified