Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
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
1 other identifier
interventional
36
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedMay 7, 2009
May 1, 2009
1.5 years
February 2, 2009
May 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
26 Weeks
Study Arms (4)
1
EXPERIMENTALALTU-238
2
EXPERIMENTALALTU-238
3
EXPERIMENTALALTU-238
4
ACTIVE COMPARATORNutropin AQ
Interventions
Eligibility Criteria
You may qualify if:
- Assent of subject, if applicable, and written informed consent of parent or legal guardian
- 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
- Available results from one or more historical CT or MRI scans of the head obtained at or following the diagnosis of GHD
- Chronologic age at Screening of 3 to 13 years (inclusive) for boys and 3 to 12 years(inclusive) for girls
- Bone age at Screening of ≤ 11 years for boys and ≤ 10 years for girls
- Pre-pubertal at Screening (Tanner stage 1 for both breast/genitalia and pubic hair
- 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)
- 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
- Screening IGF-1 SDS for chronologic age and sex \< -1
- 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
You may not qualify if:
- History of any prior rhGH, rhIGF-1, or sex steroid treatment
- History of treatment with any medications that may affect growth
- Evidence of active intracranial neoplasm per recent serial CT or MRI scans of the head or other criteria
- Surgery/chemotherapy/radiation therapy for intracranial neoplasm within the prior 52 weeks
- Any history of non-intracranial neoplasm
- History of or active benign intracranial hypertension
- High-dose chronic systemic corticosteroid treatment (oral or injected) within prior 13 weeks
- Acute or severe illness within prior 26 weeks
- 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
- History of congenital syndromes associated with abnormal growth, including Turner syndrome, Noonan syndrome, Prader-Willi syndrome, etc.
- History of severe associated pathology affecting growth, including malnutrition,malabsorption, or bone dysplasia
- History of autoimmune disease
- Serum ALT or AST ≥ 1.5X ULN
- 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
- History of any allergic or abnormal reaction to any of the components of the study drugs
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Nemours Children's Clinic
Orlando, Florida, 32806, United States
Baystate Medical Centre
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
Children's Hospital Medical Centre
Cincinnati, Ohio, 45229, United States
Cook Children's Hospital
Fort Worth, Texas, 76104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 5, 2009
Study Start
March 1, 2009
Primary Completion
September 1, 2010
Last Updated
May 7, 2009
Record last verified: 2009-05