A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saizen

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005054-31-GB

Enrollment

326

Registered

2005-05-16

Start date

2005-07-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Saizen 8 mg click.easy Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: somatropin Other descriptive name: reco

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Children with one of the following diagnoses who are candidate for Saizen therapy: A) GHD: documented pre-established diagnosis of GHD with a GH peak response of 5th and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and a history of irradiation or cranial surgery; - Previous treatment with GH, GHRH, anabolic steroids or any treatment affecting growth; - Previous treatment with corticosteroids except topical or inhaled for atopic disease; or when used for hormonal substitution if the condition and treatment regimen has been stable for at least 3 months; - Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia; - Chronic severe kidney or liver or infectious disease; - Acute or severe illness during the previous 6 months; - Active malignancy (except non-melanomatous skin malignancies that have undergone surgical excision and / or biopsy, diagnosis and treatment to resolution); - History or active Idiopathic intra-cranial hypertension; - Diabetes Mellitus type I and II - Any autoimmune disease; - Use of investigational drug or participation in another clinical study within the last three months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the most representative serum biomarkers after one month of Saizen therapy in Growth hormone deficiency (GHD) and Turner Syndrome (TS) children.; Secondary Objective: - To explore the contribution of selected genes to the phenotype of GHD and TS children; - To explore the contribution of gene polymorphisms to the levels of serum biomarkers in GHD and TS children after one month of Saizen therapy; - To explore the relationship between changes in gene expression profiling, the changes in serum biomarkers and the spectrum of gene polymorphisms in a subset of GH and TS children (defined as the 75th percentiles of IGF-I levels) after one months of Saizen therapy. ;Primary end point(s): To identify the most responsive serum biomarkers after one month of Saizen therapy in GHD and TS children.	—

Measure

Time frame

Main Objective: To identify the most representative serum biomarkers after one month of Saizen therapy in Growth hormone deficiency (GHD) and Turner Syndrome (TS) children.; Secondary Objective: - To explore the contribution of selected genes to the phenotype of GHD and TS children; - To explore the contribution of gene polymorphisms to the levels of serum biomarkers in GHD and TS children after one month of Saizen therapy; - To explore the relationship between changes in gene expression profiling, the changes in serum biomarkers and the spectrum of gene polymorphisms in a subset of GH and TS children (defined as the 75th percentiles of IGF-I levels) after one months of Saizen therapy. ;Primary end point(s): To identify the most responsive serum biomarkers after one month of Saizen therapy in GHD and TS children.

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Countries

Austria, Finland, Germany, Italy, Spain, Sweden, United Kingdom

Outcome results