Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
Information source: Altus Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Somatropin (Drug); Somatropin (Drug); Somatropin (Drug); Somatropin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Altus Pharmaceuticals Overall contact:
Dr. Kenneth Attie, Medical Monitor, Phone: 781-373-6481, Email: kattie@altus.com
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
Eligibility
Minimum age: 3 Years.
Maximum age: 13 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Assent of subject, if applicable, and written informed consent of parent or legal
guardian
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:
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
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
Locations and Contacts
Dr. Kenneth Attie, Medical Monitor, Phone: 781-373-6481, Email: kattie@altus.com
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Recruiting
Dr Stephen Kemp
Dr Stephen Kemp, Principal Investigator
Nemours Children's Clinic, Orlando, Florida 32806, United States; Recruiting
Dr. Jorge Daaboul, Phone: 407-650-7210
Dr. Jorge Daaboul, Principal Investigator
Baystate Medical Centre, Springfield, Massachusetts 01199, United States; Recruiting
Dr Edward Reiter, Phone: 413-794-5060
Dr Edward Reiter, Principal Investigator
UMass Memorial Medical Center, Worcester, Massachusetts 01655, United States; Recruiting
Dr. Leslie Soyka, Phone: 508-856-6289
Dr. Leslie Soyka, Principal Investigator
Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Dr. Finen Ugrasbul, Phone: 816-234-3973
Dr. Finen Ugrasbul, Principal Investigator
Morristown Memorial Hospital, Morristown, New Jersey 07962, United States; Recruiting
Dr. Lawrence Silverman, Phone: 973-971-6340
Dr. Lawrence Silverman, Principal Investigator
Schneider Children's Hospital, New Hyde Park, New York 11040, United States; Recruiting
Dr. Phyllis Speiser, Phone: 718-470-3290
Dr. Phyllis Speiser, Principal Investigator
Children's Hospital Medical Centre, Cincinnati, Ohio 45229, United States; Recruiting
Dr Susan Rose, Phone: 513-636-4744
Dr Susan Rose, Principal Investigator
Cook Children's Hospital, Ft. Worth, Texas 76104, United States; Recruiting
Dr. Paul Thornton, Phone: 682-885-7960
Dr. Paul Thornton, Principal Investigator
Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Dr Patricia Fetchner
Dr Patricia Fetchner, Principal Investigator
Swedish Medical Center, Seattle, Washington 98122, United States; Recruiting
Dr. Gad Kletter, Phone: 206-215-2700
Dr. Gad Kletter, Principal Investigator
Additional Information
Starting date: March 2009
Last updated: May 6, 2009
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