A Study of Zomacton in Children With Growth Hormone Deficiency

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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Drug: Genotropin; Drug: Zomacton

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Semmelweiss University, 1st dept of paediatrics
  • Budapest, Hungary
    • Szent Janos Kh Budai
  • Gyor, Hungary
    • Petz Country Teaching Hospital
  • Szeged, Hungary
    • University of Szeged
  • Szombathely, Hungary
    • Markusovszkty Teaching Hospital
• India
  • Chennai, India
    • Associates in Clinical Endocrinology Education and Research (ACEER)
  • Hyderabad, India
    • Apollo Hospitals
  • Indore, India
    • TOTALL Diabetes Hormone Institute
  • Mumbai, India
    • KEM hospital
  • Mumbai, India
    • Prince Aly Khan Hospital
  • Nasik, India
    • Endocare Clinic
  • Pune, India
    • Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
  • Trivandrum, India
    • Health & Research Centre
• Israel
  • Afula, Israel
    • HaEmek Medical Center
  • Beer Sheva, Israel
    • Soroka University Medical Center
  • Nahariya, Israel
    • Western Galilee Medical Center
  • Petach Tikva, Israel
    • Schneider Children's Medical Center of Israel
  • Ramat Gan, Israel
    • Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center
  • Rehovot, Israel
    • Kaplan Medical Center
  • Tel Aviv, Israel
    • Dana Children's Hospital - Tel-Aviv Sourasky Medical Center
• Poland
  • Bydgoszcz, Poland
    • Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy
  • Gdansk, Poland
    • Uniwersyteckie Centrum Kliniczne, Gdansk
  • Krakow, Poland
    • Uniwersytecki Szpital Dzieciecy w Krakowie
  • Szczecin, Poland
    • SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin
• Romania
  • Bucuresti, Romania
    • Societatea Civila Medicala "Dr. Paveliu"
  • Craiova, Romania
    • Spitalul Clinic Municipal "Filantropia"
  • Iasi, Romania
    • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"
  • Targu Mures, Romania
    • Spitalul Clinic Judetean Mures
  • Timisoara, Romania
    • Paediatric Endocrinology/Medicali's SRL
  • Timisoara, Romania
    • Spitalul Clinic pentru Copii Louis Turcanu
• Russian Federation
  • Kazan, Russian Federation
    • State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV
  • Moscow, Russian Federation
    • Federal State Institution
  • Moscow, Russian Federation
    • Russian Medical Academy of Post-graduate Education
  • Saint Petersburg, Russian Federation
    • Saint-Petersburg State Health Care Institution
  • Saratov, Russian Federation
    • State Educational Institution for Higher Professional Education
  • Tomsk, Russian Federation
    • State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV
• Ukraine
  • Donetsk, Ukraine
    • Donetsk Regional Clinical Children's Hospital
  • Ivano-Frankivsk, Ukraine
    • Ivano-Frankivsk Regional Children Clinical Hospital
  • Kharkiv, Ukraine
    • Kharkiv Regional Clinical Children's Hospital
  • Kiev, Ukraine
    • Institute of Endocrinology and Metabolism
  • Kiev, Ukraine
    • Ukrainian Children's Specialized Clinical Hospital
  • Odessa, Ukraine
    • Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)
  • Zaporizhya, Ukraine
    • Zaporizhzhya Regional Paediatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: Zomacton
Active Comparator: 1	Drug: Genotropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Height Velocity	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Height SDS	12 months
Height velocity SDS	12 months
Change in IGF-1 and IGFBP-3	12 months
BA (Bone Age)	12 months
Anti-hGH AB	12 months
AE and tolerability	12 months
CS Changes in safety lab, physical examination and vital signs	12 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 17, 2009
• First Posted (Estimate): April 20, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Endocrine System Diseases
• Other Study ID Numbers: FE999905 CS07; 2008-004849-28