Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency

Therapuetic Areas:Endocrinology
Age Range:3 - 13
Start Date:March 2009
Contact:Dr. Kenneth Attie, Medical Monitor

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A Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone Deficiency

The purpose of the study is to evaluate the safety and effectiveness of ALTU-238 in the
treatment of children with growth hormone deficiency who have not yet reached puberty who
lack the normal ability to make growth hormone themselves. This study will also test if
ALTU-238 works as a weekly treatment.

Inclusion Criteria:

1. Assent of subject, if applicable, and written informed consent of parent or legal

2. Diagnosis of GHD as defined by a maximum stimulated GH < 7 ng/mL (μg/L) on two
stimulation tests (using any two distinct agents from the following list: arginine,
L-dopa, clonidine, insulin, or glucagon); if two documented historical tests are not
available,test(s) must be performed during Screening period

3. Available results from one or more historical CT or MRI scans of the head obtained at
or following the diagnosis of GHD

4. Chronologic age at Screening of 3 to 13 years (inclusive) for boys and 3 to 12
years(inclusive) for girls

5. Bone age at Screening of ≤ 11 years for boys and ≤ 10 years for girls

6. Pre-pubertal at Screening (Tanner stage 1 for both breast/genitalia and pubic hair

7. For subjects with idiopathic GHD, a Screening height SDS ≤ -2.0 (standardized for
chronologic age and sex) there is no height SDS requirement if the subject has
organic GHD (as defined by a CNS lesion or insult on a historical CT or MRI scan)

8. Pre-treatment annualized height velocity ≤ median (50th percentile) for chronologic
age and sex (based on values for delayed maturers provided in Appendix 4), utilizing
Screening height and height obtained 52 ± 13 weeks (i.e. 39 to 65 weeks) prior to

9. Screening IGF-1 SDS for chronologic age and sex < -1

10. If on thyroid hormone replacement therapy, the dose must be stable for at least 6
weeks prior to Screening and the free thyroxine level (T4), TSH, and cortisol must be
within the normal range at the Screening visit

Exclusion Criteria:

1. History of any prior rhGH, rhIGF-1, or sex steroid treatment

2. History of treatment with any medications that may affect growth

3. Evidence of active intracranial neoplasm per recent serial CT or MRI scans of the
head or other criteria

4. Surgery/chemotherapy/radiation therapy for intracranial neoplasm within the prior 52

5. Any history of non-intracranial neoplasm

6. History of or active benign intracranial hypertension

7. High-dose chronic systemic corticosteroid treatment (oral or injected) within prior
13 weeks

8. Acute or severe illness within prior 26 weeks

9. History of diabetes mellitus, anorexia nervosa, cystic fibrosis, chronic severe
kidney or liver disease, chronic infectious disease, inborn errors of metabolism,
chromosomal disorders, intrauterine growth retardation, or other childhood disease
associated with growth failure

10. History of congenital syndromes associated with abnormal growth, including Turner
syndrome, Noonan syndrome, Prader-Willi syndrome, etc.

11. History of severe associated pathology affecting growth, including
malnutrition,malabsorption, or bone dysplasia

12. History of autoimmune disease

13. Serum ALT or AST ≥ 1.5X ULN

14. Participation in another clinical trial or treatment with any investigational agent
(drug or biologic) within 30 days prior to Baseline if the half-life of the agent is
known to be ≤ 6 days or within 6 weeks prior to Baseline if the half-life is > 6 days
or not known

15. History of any allergic or abnormal reaction to any of the components of the study

16. Any previous or ongoing clinically significant illness, PE findings, or laboratory
abnormality that, in the opinion of the Investigator or the Medical Monitor, could
prevent the subject from completing the protocol-specified requirements successfully

17. Poor likelihood, in the Investigator's opinion, that the subject will comply with
protocol requirements (e.g., uncooperative attitude, inability to return for
follow-up visits, history of medical noncompliance) and/or poor likelihood of
completing the study
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