A Study of Zomacton in Children With Growth Hormone Deficiency

NCT00884000 | Completed Phase 3

• 2 other identifiers: FE999905 CS072008-004849-28
• Study Type: interventional
• Target: 165
• Locations: 7 countries
• Sites: 43

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.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Height Velocity

  12 months

Secondary Outcomes (7)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Genotropin

2

EXPERIMENTAL

Drug: Zomacton

Interventions

Genotropin DRUG

1

Zomacton DRUG

2

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (43)

Semmelweiss University, 1st dept of paediatrics

Budapest, Hungary

Location

Szent Janos Kh Budai

Budapest, Hungary

Location

Petz Country Teaching Hospital

Győr, Hungary

Location

University of Szeged

Szeged, Hungary

Location

Markusovszkty Teaching Hospital

Szombathely, Hungary

Location

Associates in Clinical Endocrinology Education and Research (ACEER)

Chennai, India

Location

Apollo Hospitals

Hyderabad, India

Location

TOTALL Diabetes Hormone Institute

Indore, India

Location

KEM Hospital

Mumbai, India

Location

Prince Aly Khan Hospital

Mumbai, India

Location

Endocare Clinic

Nashik, India

Location

Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital

Pune, India

Location

Health & Research Centre

Trivandrum, India

Location

Haemek Medical Center

Afula, Israel

Location

Soroka University Medical Center

Beersheba, Israel

Location

Western Galilee Medical Center

Nahariya, Israel

Location

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

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

Tel Aviv, Israel

Location

Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy

Bydgoszcz, Poland

Location

Uniwersyteckie Centrum Kliniczne, Gdańsk

Gdansk, Poland

Location

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, Poland

Location

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

Szczecin, Poland

Location

Societatea Civila Medicala "Dr. Paveliu"

Bucharest, Romania

Location

Spitalul Clinic Municipal "Filantropia"

Craiova, Romania

Location

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"

Iași, Romania

Location

Spitalul Clinic Judetean Mures

Târgu Mureş, Romania

Location

Paediatric Endocrinology/Medicali's SRL

Timișoara, Romania

Location

Spitalul Clinic pentru Copii Louis Turcanu

Timișoara, Romania

Location

State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV

Kazan', Russia

Location

Federal State Institution

Moscow, Russia

Location

Russian Medical Academy of Post-graduate Education

Moscow, Russia

Location

Saint-Petersburg State Health Care Institution

Saint Petersburg, Russia

Location

State Educational Institution for Higher Professional Education

Saratov, Russia

Location

State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV

Tomsk, Russia

Location

Donetsk Regional Clinical Children's Hospital

Donetsk, Ukraine

Location

Ivano-Frankivsk Regional Children Clinical Hospital

Ivano-Frankivsk, Ukraine

Location

Kharkiv Regional Clinical Children's Hospital

Kharkiv, Ukraine

Location

Institute of Endocrinology and Metabolism

Kiev, Ukraine

Location

Ukrainian Children's Specialized Clinical Hospital

Kiev, Ukraine

Location

Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)

Odesa, Ukraine

Location

Zaporizhzhya Regional Paediatric Hospital

Zaporizhya, Ukraine

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

IN (8); PL (4); RO (6); HU (5); IL (7); RU (6); UA (7)