Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
NCT ID: NCT00837863
Last Updated: 2009-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
36 participants
INTERVENTIONAL
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
ALTU-238
Somatropin
ALTU-238 0.3 mg/kg daily
2
ALTU-238
Somatropin
ALTU-238 0.6 mg/kg daily
3
ALTU-238
Somatropin
ALTU-238 0.9 mg/kg daily
4
Nutropin AQ
Somatropin
Nutropin AQ 0.043 mg/kg daily
Interventions
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Somatropin
ALTU-238 0.3 mg/kg daily
Somatropin
ALTU-238 0.6 mg/kg daily
Somatropin
ALTU-238 0.9 mg/kg daily
Somatropin
Nutropin AQ 0.043 mg/kg daily
Eligibility Criteria
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Inclusion Criteria
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 Screening
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
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 weeks
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 drugs
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
3 Years
13 Years
ALL
No
Sponsors
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Altus Pharmaceuticals
INDUSTRY
Responsible Party
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Altus Pharmaceuticals
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Nemours Children's Clinic
Orlando, Florida, United States
Baystate Medical Centre
Springfield, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Children's Hospital Medical Centre
Cincinnati, Ohio, United States
Cook Children's Hospital
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Dr Stephen Kemp
Role: primary
Dr. Jorge Daaboul
Role: primary
Dr Edward Reiter
Role: primary
Dr. Leslie Soyka
Role: primary
Dr. Finen Ugrasbul
Role: primary
Dr. Lawrence Silverman
Role: primary
Dr. Phyllis Speiser
Role: primary
Dr Susan Rose
Role: primary
Dr. Paul Thornton
Role: primary
Dr Patricia Fetchner
Role: primary
Dr. Gad Kletter
Role: primary
Other Identifiers
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0001194
Identifier Type: -
Identifier Source: org_study_id
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