A Study of Zomacton in Children With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00884000
• Date of registration: 17/04/2009
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: A Study of Zomacton in Children With Growth Hormone Deficiency
• Scientific title: A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency
• Date of first enrolment: January 2010
• Target sample size: 165
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00884000
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Hungary, India, Israel, Poland, Romania, Russian Federation, Ukraine

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent

2. Children aged =3yrs old and not above 10 yrs for girls or 11 yrs for boys

3. 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)

4. Height SDS <-2 SD of ref value for CA

5. Height velocity SDSCA = 0 SD of ref value for at lease 6 months prior to
pre-screening

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

7. The difference between CA-BA= 1

8. 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:

1. BA above 9 yrs for girls and 10 yrs for boys

2. Puberty Tanner stage >1

3. Weight <12 Kg at screening

4. Any prior treatment with GH

5. Closed epiphysis

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

7. Any other diagnosed or suspected endocrine or metabolic disorder

8. Any diagnosed or suspected sever chronic disease

9. Clinical signs of dysmorphic features, malformations or mental retardations

10. Growth failure due to other disorders

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

12. Diagnosed malignant disease

13. Any abnormal CS lab results that requires further investigation

14. 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

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



Age minimum: 3 Years
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Genotropin

Drug: Zomacton

Primary Outcome(s)

Height Velocity [Time Frame: 12 months]

Secondary Outcome(s)

AE and tolerability [Time Frame: 12 months]

CS Changes in safety lab, physical examination and vital signs [Time Frame: 12 months]

Height velocity SDS [Time Frame: 12 months]

Anti-hGH AB [Time Frame: 12 months]

Change in IGF-1 and IGFBP-3 [Time Frame: 12 months]

BA (Bone Age) [Time Frame: 12 months]

Height SDS [Time Frame: 12 months]

Secondary ID(s)

2008-004849-28

FE999905 CS07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors