ong Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

Phase 1

Conditions: Small for Gestational Age
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
MedDRA version: 19.0Level: LLTClassification code 10041093Term: Small for gestational ageSystem Organ Class: 100000004868

Registration Number: EUCTR2015-004552-21-Outside-EU/EEA

Lead Sponsor: Pfizer Japan Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 62

Inclusion Criteria

Children with short stature due to SGA who received treatment in the study GENASG-0021-002
Are the trial subjects under 18? yes
Number of subjects for this age range: 62
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
- Children who have received radiotherapy or chemotherapy.
- Children who have serious cardiac disease, renal disease, or hepatic disease.
- Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
- Children who have serious chronic disease.
- Children who have malignant tumor.
- Children who are allergic to m-cresol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety of long-term administration of PNU-180307 (Genotropin®) until a final height was reached in short children born SGA without epiphyseal closure.;Secondary Objective: 1.To examine height velocity, height velocity Standard Deviation Score (SDS) for chronological age, height SDS for chronological age and ? height SDS for chronological age<br>2.To comprehensively evaluate height velocity SDS for bone age, height SDS for bone age and ? height SDS for bone age to examine the relationship between bone age and height increase<br>3.To examine changes in daily lives of children with PNU-180307 (Genotropin®) treatment by means of questionnaires;Timepoint(s) of evaluation of this end point: Month 12 (at the end of previous study) to 156;Primary end point(s): Safety (laboratory test parameters and adverse events)<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Height velocity SDS for chronological age.<br> - Height velocity.<br> - Height SDS for chronological age.<br> - Height velocity SDS for bone age.<br> - Height SDS for bone age.<br><br>;Timepoint(s) of evaluation of this end point: Every 6 months of Treatment.