Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children (PD)

GeneScience Pharmaceuticals (GenSci)

Status and phase

Completed

Phase 2

Conditions

Growth Hormone Deficiency

Treatments

Drug: pegylated Somatropin

Drug: Jintropin AQ

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01342146

GenSci-004 CT

Details and patient eligibility

About

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.

Enrollment

101 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);
be in preadolescence (Tanner stage 1) and have a CA >3 years;
have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;
receive no prior GH treatment.
sign informed consent

Exclusion criteria