A Study of Zomacton in Children with Growth Hormone Deficiency.

Phase 3

Completed

• Conditions: Health Condition 1: null- idiopathic growth hormone deficiency

• Registration Number: CTRI/2011/04/001669
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 138

Inclusion Criteria

Signed informed consent

Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys

Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of 10ng/ml pr lower if so required by the country specific board(s)

Height SDS ≤2 SD of ref value for CA

Height velocity SDSCA ≤ 0 SD of ref value for at least 6 months prior to pre-screening

Height recorded for at least 6 months but not more than 18 months of pre-screening

The difference between CA-BA≥ 1

A positive locally performed GH stimulation test (defined as a peak plasma level of ≤9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening

Exclusion Criteria

BA (Bone age) above 9 yrs for girls and 10 yrs for boys

Puberty Tanner stage 1

Weight 12 Kg at screening

Any prior treatment with GH

Closed epiphysis

Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turners or seckel syndrome) which possibly could affect growth

Any other diagnosed or suspected endocrine or metabolic disorder

Any diagnosed or suspected sever chronic disease

Clinical signs of dysmorphic features, malformations or mental retardations

Growth failure due to other disorders

Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)

Diagnosed malignant disease

Any abnormal CS lab results that requires further investigation

Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial

Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin

Study & Design

• Study Type: Interventional
• Study Design: Not specified