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A Study of Zomacton in Children With Growth Hormone Deficiency

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Genotropin
Zomacton
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Semmelweiss University, 1st dept of paediatrics
  • Szent Janos Kh Budai
  • Petz Country Teaching Hospital
  • University of Szeged
  • Markusovszkty Teaching Hospital
  • Associates in Clinical Endocrinology Education and Research (ACEER)
  • Apollo Hospitals
  • TOTALL Diabetes Hormone Institute
  • KEM Hospital
  • Prince Aly Khan Hospital
  • Endocare Clinic
  • Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
  • Health & Research Centre
  • Haemek Medical Center
  • Soroka University Medical Center
  • Western Galilee Medical Center
  • Schneider Children's Medical Center of Israel
  • Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Dana Children's Hospital - Tel-Aviv Sourasky Medical Center
  • Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy
  • Uniwersyteckie Centrum Kliniczne, Gdańsk
  • Uniwersytecki Szpital Dziecięcy w Krakowie
  • SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin
  • Societatea Civila Medicala "Dr. Paveliu"
  • Spitalul Clinic Municipal "Filantropia"
  • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"
  • Spitalul Clinic Judetean Mures
  • Paediatric Endocrinology/Medicali's SRL
  • Spitalul Clinic pentru Copii Louis Turcanu
  • State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV
  • Federal State Institution
  • Russian Medical Academy of Post-graduate Education
  • Saint-Petersburg State Health Care Institution
  • State Educational Institution for Higher Professional Education
  • State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV
  • Donetsk Regional Clinical Children's Hospital
  • Ivano-Frankivsk Regional Children Clinical Hospital
  • Kharkiv Regional Clinical Children's Hospital
  • Institute of Endocrinology and Metabolism
  • Ukrainian Children's Specialized Clinical Hospital
  • Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)
  • Zaporizhzhya Regional Paediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Height Velocity

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2009
Last Updated
July 16, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00884000
Brief Title
A Study of Zomacton in Children With 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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Genotropin
Intervention Type
Drug
Intervention Name(s)
Zomacton
Primary Outcome Measure Information:
Title
Height Velocity
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Height SDS
Time Frame
12 months
Title
Height velocity SDS
Time Frame
12 months
Title
Change in IGF-1 and IGFBP-3
Time Frame
12 months
Title
BA (Bone Age)
Time Frame
12 months
Title
Anti-hGH AB
Time Frame
12 months
Title
AE and tolerability
Time Frame
12 months
Title
CS Changes in safety lab, physical examination and vital signs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 lease 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 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, Turner's 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweiss University, 1st dept of paediatrics
City
Budapest
Country
Hungary
Facility Name
Szent Janos Kh Budai
City
Budapest
Country
Hungary
Facility Name
Petz Country Teaching Hospital
City
Gyor
Country
Hungary
Facility Name
University of Szeged
City
Szeged
Country
Hungary
Facility Name
Markusovszkty Teaching Hospital
City
Szombathely
Country
Hungary
Facility Name
Associates in Clinical Endocrinology Education and Research (ACEER)
City
Chennai
Country
India
Facility Name
Apollo Hospitals
City
Hyderabad
Country
India
Facility Name
TOTALL Diabetes Hormone Institute
City
Indore
Country
India
Facility Name
KEM Hospital
City
Mumbai
Country
India
Facility Name
Prince Aly Khan Hospital
City
Mumbai
Country
India
Facility Name
Endocare Clinic
City
Nasik
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
City
Pune
Country
India
Facility Name
Health & Research Centre
City
Trivandrum
Country
India
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Western Galilee Medical Center
City
Nahariya
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikva
Country
Israel
Facility Name
Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Name
Dana Children's Hospital - Tel-Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy
City
Bydgoszcz
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Gdańsk
City
Gdansk
Country
Poland
Facility Name
Uniwersytecki Szpital Dziecięcy w Krakowie
City
Krakow
Country
Poland
Facility Name
SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin
City
Szczecin
Country
Poland
Facility Name
Societatea Civila Medicala "Dr. Paveliu"
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Municipal "Filantropia"
City
Craiova
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"
City
Iasi
Country
Romania
Facility Name
Spitalul Clinic Judetean Mures
City
Targu Mures
Country
Romania
Facility Name
Paediatric Endocrinology/Medicali's SRL
City
Timisoara
Country
Romania
Facility Name
Spitalul Clinic pentru Copii Louis Turcanu
City
Timisoara
Country
Romania
Facility Name
State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV
City
Kazan
Country
Russian Federation
Facility Name
Federal State Institution
City
Moscow
Country
Russian Federation
Facility Name
Russian Medical Academy of Post-graduate Education
City
Moscow
Country
Russian Federation
Facility Name
Saint-Petersburg State Health Care Institution
City
Saint Petersburg
Country
Russian Federation
Facility Name
State Educational Institution for Higher Professional Education
City
Saratov
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV
City
Tomsk
Country
Russian Federation
Facility Name
Donetsk Regional Clinical Children's Hospital
City
Donetsk
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Children Clinical Hospital
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Children's Hospital
City
Kharkiv
Country
Ukraine
Facility Name
Institute of Endocrinology and Metabolism
City
Kiev
Country
Ukraine
Facility Name
Ukrainian Children's Specialized Clinical Hospital
City
Kiev
Country
Ukraine
Facility Name
Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)
City
Odessa
Country
Ukraine
Facility Name
Zaporizhzhya Regional Paediatric Hospital
City
Zaporizhya
Country
Ukraine

12. IPD Sharing Statement

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A Study of Zomacton in Children With Growth Hormone Deficiency

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