Active clinical trials for "Dwarfism, Pituitary"

Hypotheses: The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes. Aims: Determine the prevalence and types of endocrinopathies in children diagnosed with ONH. Correlate endocrine outcome with radiographic, ocular, and developmental findings in children with ONH. Examine the effect of GH treatment on growth and obesity in children with ONH, GH-deficiency, and either subnormal or normal growth compared to children with ONH that are not GH-deficient. Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies.

OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo. II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH. III. Compare the quality of life of these patients treated with these 2 regimens. IV. Determine the side effects of GH in these patients.

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.

This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD), who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD which was stopped at least 1 month prior to Screening and have no contraindication to the use of GH.

The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.

Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early pubertal children with growth hormone deficiency (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled dosage group (group B).

This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.

The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.