A Study of Zomacton in Children With Growth Hormone Deficiency

Condition(s) targeted: Growth Hormone Deficiency

Intervention: Genotropin (Drug); Zomacton (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com

This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.

Official 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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Height Velocity

Secondary outcome:

Height SDS

Height velocity SDS

Change in IGF-1 and IGFBP-3

BA (Bone Age)

Anti-hGH AB

AE and tolerability

CS Changes in safety lab, physical examination and vital signs

Minimum age: 3 Years. Maximum age: 11 Years. Gender(s): Both.

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 <9ng/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

Clinical Development Support, Email: DK0-Disclosure@ferring.com

Semmelweiss University, 1st dept of paediatrics, Budapest, Hungary

Szent Janos Kh Budai, Budapest, Hungary

Petz Country Teaching Hospital, Gyor, Hungary

University of Szeged, Szeged, Hungary

Markusovszkty Teaching Hospital, Szombathely, Hungary

Haemek Medical Center, Afula, Israel

Soroka University Medical Center, Beer Sheva, Israel

Schneider Children's Medical Center of Israel, Petach Tikva, Israel

Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center, Ramat Gan, Israel

Kaplan Medical Center, Rehovot, Israel

Dana Children's Hospital - Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel

Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy, Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne, Gdańsk, Gdansk, Poland

Uniwersytecki Szpital Dziecięcy w Krakowie, Krakow, Poland

SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin, Szczecin, Poland

Societatea Civila Medicala "Dr. Paveliu", Bucuresti, Romania

Spitalul Clinic Municipal "Filantropia", Craiova, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon", Iasi, Romania

Spitalul Clinic Judetean Mures, Targu Mures, Romania

Spitalul Clinic pentru Copii Louis Turcanu, Timisoara, Romania

Donetsk Regional Clinical Children's Hospital, Donetsk, Ukraine

Kharkiv Regional Clinical Children's Hospital, Kharkiv, Ukraine

Institute of Endocrinology and Metabolism, Kiev, Ukraine

Ukrainian Children's Specialized Clinical Hospital, Kiev, Ukraine

Zaporizhzhya Regional Paediatric Hospital, Zaporizhya, Ukraine

Starting date: September 2009
Ending date: September 2011
Last updated: August 13, 2009