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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


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


Minimum age: 3 Years. Maximum age: 13 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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