A Study of Zomacton in Children With Growth Hormone Deficiency

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884000
• Other study ID #: FE999905 CS07
• Secondary ID: 2008-004849-28
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2009
• Last updated: July 16, 2012
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: Ethics CommissionUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthRomania: National Medicines AgencyRomania: National Authority for Scientific ResearchPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthHungary: National Institute of PharmacyGermany: German Institute of Medical Documentation and InformationGermany: Ethics CommissionRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationRussia: Pharmacological Committee, Ministry of HealthIndia: Drugs Controller General of IndiaIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• Genotropin

• Zomacton

Locations

Country	Name	City	State
Hungary	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
India	Associates in Clinical Endocrinology Education and Research (ACEER)	Chennai
India	Apollo Hospitals	Hyderabad
India	TOTALL Diabetes Hormone Institute	Indore
India	KEM Hospital	Mumbai
India	Prince Aly Khan Hospital	Mumbai
India	Endocare Clinic	Nasik
India	Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital	Pune
India	Health & Research Centre	Trivandrum
Israel	Haemek Medical Center	Afula
Israel	Soroka University Medical Center	Beer Sheva
Israel	Western Galilee Medical Center	Nahariya
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
Poland	Wojewódzki Szpital Dzieciecy im. J.Brudzinskiego w Bydgoszczy	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne, Gdansk	Gdansk
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow
Poland	SPSK nr.1 im. Prof. T. Sokolowskiego PAM Szczecin	Szczecin
Romania	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	Paediatric Endocrinology/Medicali's SRL	Timisoara
Romania	Spitalul Clinic pentru Copii Louis Turcanu	Timisoara
Russian Federation	State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV	Kazan
Russian Federation	Federal State Institution	Moscow
Russian Federation	Russian Medical Academy of Post-graduate Education	Moscow
Russian Federation	Saint-Petersburg State Health Care Institution	Saint Petersburg
Russian Federation	State Educational Institution for Higher Professional Education	Saratov
Russian Federation	State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV	Tomsk
Ukraine	Donetsk Regional Clinical Children's Hospital	Donetsk
Ukraine	Ivano-Frankivsk Regional Children Clinical Hospital	Ivano-Frankivsk
Ukraine	Kharkiv Regional Clinical Children's Hospital	Kharkiv
Ukraine	Institute of Endocrinology and Metabolism	Kiev
Ukraine	Ukrainian Children's Specialized Clinical Hospital	Kiev
Ukraine	Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)	Odessa
Ukraine	Zaporizhzhya Regional Paediatric Hospital	Zaporizhya

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height Velocity		12 months	No
Secondary	Height SDS		12 months	No
Secondary	Height velocity SDS		12 months	No
Secondary	Change in IGF-1 and IGFBP-3		12 months	No
Secondary	BA (Bone Age)		12 months	No
Secondary	Anti-hGH AB		12 months	Yes
Secondary	AE and tolerability		12 months	Yes
Secondary	CS Changes in safety lab, physical examination and vital signs		12 months	Yes