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A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Short Stature

Intervention: Saizen® (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Responsible, Study Director, Affiliation: Merck Ltd.

Summary

This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0. 067 milligram/kilogram/day (mg/kg/day) of Saizen, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).

Clinical Details

Official title: A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in growth velocity (centimeter/year [cm/yr]) at Month 6

Secondary outcome:

Change from baseline in growth velocity (cm/yr) at Month 12

Changes from baseline in height (centimeter [cm]) at Month 6 and 12

Changes from baseline in height standard deviation score (SDS) at Month 6 and 12

Changes from baseline in serum concentration of insulin-like growth factor-I (IGF-I) and insulin like growth factor binding protein-3 (IGFBP-3) at Month 6 and 12

Percentage of participants who adhered to study treatment

Number of participants with adverse events (AEs)

Eligibility

Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age greater than or equal to 5 years

- Pre-pubertal; testicular volume less than 4 milliliter (in males) and breast Stage 1

(in females)

- The official records of height (for example records measured in hospitals or schools)

during previous 6 months or more preceding inclusion in the study (self-measurement of the height at home will not be considered as a valid record)

- Height less than or equal to 3rd percentile compared to same sex, same age

- Peak serum growth hormone (GH) greater than 10 microgram per liter (mcg/L) in GH

stimulation test (results of peak serum GH greater than 10 mcg/L in GH stimulation test within 1 year can be used instead)

- Naive to GH therapy

- Normal birth weight (that is greater than or equal to 3rd percentile when compared to

same sex)

- Normal thyroid function

- Normal karyotype in girls

- Written informed consent from parent/guardian

- Written informed consent from the subject who speaks, understand, read, and write

Korean

- Bone age less than 10 years in boys and less than 9 years in girls, whose difference

between the bone and chronological age is no more than 3 years Exclusion Criteria:

- Puberty development (Tanner stage greater than or equal to 2)

- Skeletal dysplasia or abnormal body proportions

- Chronic systemic illness

- Dysmorphic syndrome

- Growth Hormone Deficiency

- Small for Gestational Age (SGA)

- Current medication for Attention deficit hyperactivity disorder (ADHD) or

hyperactivity disorder

- Current medication with drugs that may influence secretion or action of growth

hormone (such as estrogen, androgen, anabolic steroid, corticosteroid, thyroxine, aromatase inhibitors)

- Diabetes mellitus

- Kidney transplantation

- Acute critical illness, including complications following open heart surgery,

abdominal surgery or multiple accidental trauma

- Acute respiratory failure

- Malignancy or previous therapy for malignancy

- Known hypersensitivity to somatotropin or any of its excipients including cresol or

glycerol

- Closed epiphyses, progression or recurrence of an underlying intracranial tumor,

chronic renal disease

- Endocrinologic or metabolic disorders such as Prader-Willi syndrome; Russel-Silver

syndrome; Seckel syndrome; Down syndrome; Cushing syndrome; Noonan syndrome; short stature caused by other chromosomal abnormalities

- The disorders that explain short stature such as psychiatric disorders, nutritional

disorders, and chronic debilitating diseases

- Participation in another clinical trial within the past 3 months

- Status of legal incapacity or limited legal capacity of the parents or legal guardian

Locations and Contacts

Please contact Merck KGaA Communication Center for Recruiting Sites, Located in, Korea, Republic of
Additional Information

Starting date: January 2013
Last updated: July 20, 2015

Page last updated: August 23, 2015

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