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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pegylated Somatropin

0.1 mg/kg/wk once a week for 25 weeks

Intervention Type DRUG

pegylated Somatropin

0.2 mg/kg/wk once a week for 25 weeks

Intervention Type DRUG

Jintropin AQ

0.25 mg/kg/wk, once a day for 25 weeks

Intervention Type DRUG

Other Intervention Names

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PEG-rhGH,PEG-growth hormone,PEG-Somatropin PEG-rhGH,PEG-growth hormone,PEG-Somatropin Somatropin injectable solution,rhGH injection

Eligibility Criteria

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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

* patients with severe cardiopulmonary
* patients with hematological diseases
* a current or past history of malignant tumors
* immunodeficiency diseases
* mental diseases
* patients positive for hepatitis B e-antibody (HBeAb)
* hepatitis B surface antigen (HBsAg)
* hepatitis B e antigen (HBeAg)
* patients with other growth disorders, such as Turner syndrome
* constitutional delay of growth and puberty, and Laron syndrome

Eligible Sex

ALL

Accepts Healthy Volunteers

No