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 because the information has not been verified recently.
Verified May 2009 by Altus Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Altus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00837863
First received: February 2, 2009
Last updated: May 6, 2009
Last verified: May 2009
  Purpose

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 ] [ Designated as safety issue: No ]

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
ALTU-238
Drug: Somatropin
ALTU-238 0.3 mg/kg daily
Experimental: 2
ALTU-238
Drug: Somatropin
ALTU-238 0.6 mg/kg daily
Experimental: 3
ALTU-238
Drug: Somatropin
ALTU-238 0.9 mg/kg daily
Active Comparator: 4
Nutropin AQ
Drug: Somatropin
Nutropin AQ 0.043 mg/kg daily

  Eligibility

Ages Eligible for Study:   3 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837863

Contacts
Contact: Dr. Kenneth Attie, Medical Monitor 781-373-6481 kattie@altus.com

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Dr Stephen Kemp         
Principal Investigator: Dr Stephen Kemp         
United States, Florida
Nemours Children's Clinic Recruiting
Orlando, Florida, United States, 32806
Contact: Dr. Jorge Daaboul    407-650-7210      
Principal Investigator: Dr. Jorge Daaboul         
United States, Massachusetts
Baystate Medical Centre Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Dr Edward Reiter    413-794-5060      
Principal Investigator: Dr Edward Reiter         
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Dr. Leslie Soyka    508-856-6289      
Principal Investigator: Dr. Leslie Soyka         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Dr. Finen Ugrasbul    816-234-3973      
Principal Investigator: Dr. Finen Ugrasbul         
United States, New Jersey
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Dr. Lawrence Silverman    973-971-6340      
Principal Investigator: Dr. Lawrence Silverman         
United States, New York
Schneider Children's Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Dr. Phyllis Speiser    718-470-3290      
Principal Investigator: Dr. Phyllis Speiser         
United States, Ohio
Children's Hospital Medical Centre Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Dr Susan Rose    513-636-4744      
Principal Investigator: Dr Susan Rose         
United States, Texas
Cook Children's Hospital Recruiting
Ft. Worth, Texas, United States, 76104
Contact: Dr. Paul Thornton    682-885-7960      
Principal Investigator: Dr. Paul Thornton         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Dr. Gad Kletter    206-215-2700      
Principal Investigator: Dr. Gad Kletter         
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Dr Patricia Fetchner         
Principal Investigator: Dr Patricia Fetchner         
Sponsors and Collaborators
Altus Pharmaceuticals
  More Information

No publications provided

Responsible Party: Kenneth Attie, M.D., Altus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00837863     History of Changes
Other Study ID Numbers: 0001194
Study First Received: February 2, 2009
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014