Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age (SGA)

Sandoz

Status: Terminated

Conditions: Short Children Born Small for Gestational Age (SGA)

Treatments: Other: Bloodsampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491854

CEP00-402

Details and patient eligibility

About

This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Full description

The purpose of this study is

1. to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment

   and

2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.

Enrollment: 130 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
• Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian

Exclusion criteria

• Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Monitoring of long-term safety

Other group

Description:

Long-term safety follow-up after the end of treatment with Omnitrope (single arm)

Treatment:

Other: Bloodsampling