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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Altus Pharmaceuticals.
Recruitment status was:  Recruiting
Information provided by:
Altus Pharmaceuticals Identifier:
First received: February 2, 2009
Last updated: May 6, 2009
Last verified: May 2009
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.

Condition Intervention Phase
Growth Hormone Deficiency
Drug: Somatropin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Altus Pharmaceuticals:

Primary Outcome Measures:
  • Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment [ Time Frame: 26 Weeks ]

Estimated Enrollment: 36
Study Start Date: March 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Somatropin
ALTU-238 0.3 mg/kg daily
Experimental: 2
Drug: Somatropin
ALTU-238 0.6 mg/kg daily
Experimental: 3
Drug: Somatropin
ALTU-238 0.9 mg/kg daily
Active Comparator: 4
Nutropin AQ
Drug: Somatropin
Nutropin AQ 0.043 mg/kg daily


Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00837863

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Florida
Nemours Children's Clinic
Orlando, Florida, United States, 32806
United States, Massachusetts
Baystate Medical Centre
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
United States, Ohio
Children's Hospital Medical Centre
Cincinnati, Ohio, United States, 45229
United States, Texas
Cook Children's Hospital
Ft. Worth, Texas, United States, 76104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Altus Pharmaceuticals
  More Information

Responsible Party: Kenneth Attie, M.D., Altus Pharmaceuticals Identifier: NCT00837863     History of Changes
Other Study ID Numbers: 0001194 
Study First Received: February 2, 2009
Last Updated: May 6, 2009

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on February 20, 2017