Predictive Markers in GHD and TS Children Treated With SAIZEN®
Information source: EMD Serono
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Saizen (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: EMD Serono Official(s) and/or principal investigator(s):
Clement Olivier, Study Chair, Affiliation: Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
Summary
The study aims at identifying the predictive markers after one month of Saizen therapy in
Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit
approximately 360 children in several countries worldwide. The study lasts for about the
first one month of daily growth hormone treatment. There will be three clinic visits during
the month of the study. There is an initial visit, then a visit before growth hormone
treatment starts and finally a visit at the fourth week of treatment. The study requires two
additional blood tests to a regular Saizen treatment follow-up. One sample is taken before
growth hormone injections start and one additional blood sample is taken at the fourth week
of treatment.
Clinical Details
Official title: A Phase IV Open-Label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-Pubertal Children Treated With SAIZEN®
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Changes in serum IGF-1 levels after one month in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children
Secondary outcome: In Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children after one month Saizen therapy:The changes of IGBP-3 levels The changes of glycemia and insulinemia, insulin resistance (HOMA-IR analysis) The changes of alkaline phosphatase
Eligibility
Minimum age: 2 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- One of the following diagnoses and candidacy for SAIZEN® therapy:
A)GHD: documented pre-established diagnosis of GHD with a GH peak response of <10 μg/L with
2 GH stimulation tests, without priming with oestradiol.
B)Turner syndrome: documented pre-established diagnosis by karyotype.
- Prepubertal status according to Tanner Pre-established history of normal thyroid
function or adequate substitution for at least 3 months.
- Weight for stature within the population specific normal range (>5th and <95th
percentiles) for gender Willingness and ability to comply with the protocol for the
duration of the study.
- Parent's or guardian's written informed consent, given before any study related
procedure that is not part of the subject's normal medical care, with the
understanding that the subject or parent/guardian may withdraw consent at any time
without prejudice to future medical care. If the child is old enough to read and
write, a separate assent form will be given.
Exclusion Criteria:
- Acquired GHD due to central nervous system tumour, trauma, infection, infiltration
(documented by imaging), and history of irradiation or cranial surgery
- Previous treatment with GH, GHRH, anabolic steroids or any treatment affecting
growth.
- Previous treatment with corticosteroids, except in case of topical or inhaled
corticosteroid administration for atopic disease. Corticosteroids for hormonal
substitution are also allowed if the condition and the treatment regimen have been
stable for at least 3 months.
- Severe associated pathology affecting growth such as malnutrition, malabsorption, or
bone dysplasia.
- Chronic severe kidney disease.
- Chronic severe liver disease.
- Chronic infectious disease.
- Acute or severe illness during the previous 6 months.
- Significant concomitant illness that would interfere with participation or assessment
in this study.
- 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 (benign intracranial
hypertension or pseudo-tumor cerebri).
- Diabetes Mellitus type I & II.
- Any autoimmune disease.
- Previous screening failure in this study.
- Use of an investigational drug or participation in another clinical study within the
last three months.
Locations and Contacts
Local Medical Information Office, Buenos Aires, Argentina
Local Medical Information Office, Sydney, Australia
Local Medical Information Office, Vienna, Austria
Local Medical Information Office, Mississauga, Canada
Local Medical InformationOffice, Paris, France
Local Medical Information Office, Munich, Germany
Local Medical Information Office, Rome, Italy
Local Medical Information Office, Oslo, Norway
Local Medical Information Office, Russia, Russian Federation
Local Medical Information Office, Singapore, Singapore
Local Medical Information Office, Madrid, Spain
Local Medical Information Office, Stockholm, Sweden
Local Medical Information Office, Feltham, United Kingdom
Additional Information
Full FDA approved prescribing information can be found here
Starting date: May 2005
Ending date: October 2007
Last updated: February 4, 2008
|
