A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A

Pfizer Pharma GmbH0 个研究点目标入组 32 人开始时间: 2006年4月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Male and female children with a minimum age of 6 years.
•2. Pre-pubertal as defined by Tanner staging (Tanner JM, 1962).
•3. Growth hormone deficiency as defined by GRS Guidelines; GH<8 ng/ml on dynamic testing, together with serum IGF-1 level =-1.5 SD. Evidence of severe GHD should be demonstrated by 1 dynamic test if there is supporting pathology, or 2 dynamic tests in the absence of supporting pathology.
•4. Growth hormone pre-treatment for at least 6 months prior to the screening visit.
•5. Hypopituitary patients must be on adequate hormone replacement therapy.
•6. Written informed consent of legally authorized representative (i.e. Parent/Legal Guardian). In addition if possible, assent should be obtained from the child to take part in the study.
•7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•1. PGHD subjects with uncontrolled pituitary tumor growth. Subjects with pituitary tumors must have demonstrated stable neuro-imaging within the last 12 months of the screening visit.
•2. Tumors within 3 mm of the optic chiasm. Subjects with residual pituitary suprasellar disease must be scanned within 3 months of the screening visit.
•3. Serum ALT and/or AST = 1.5 times the upper limit of normal range (ULN), or clinically significant hepatic disease.
•4. Subjects with diabetes mellitus.
•5. Any defined syndrome with short stature
•6. Subjects with birth weight and/or birth length = 10th centile.
•7. Subjects with body weight below 16 kg.
•8. Subjects who have received any experimental drug within the past four months (prior to the first dosing day of the study).
•9. Concomitant therapy with other investigational drugs.
•10. Subjects with a history of clinically significant allergies, especially drug hypersensitivity.
•11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration, or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
•12. Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.

发起方