- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837863
Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
May 6, 2009 updated by: Altus Pharmaceuticals
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dr. Kenneth Attie, Medical Monitor
- Phone Number: 781-373-6481
- Email: kattie@altus.com
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- Recruiting
- Arkansas Children's Hospital
-
Contact:
- Dr Stephen Kemp
-
Principal Investigator:
- Dr Stephen Kemp
-
-
Florida
-
Orlando, Florida, United States, 32806
- Recruiting
- Nemours Children's Clinic
-
Contact:
- Dr. Jorge Daaboul
- Phone Number: 407-650-7210
-
Principal Investigator:
- Dr. Jorge Daaboul
-
-
Massachusetts
-
Springfield, Massachusetts, United States, 01199
- Recruiting
- Baystate Medical Centre
-
Contact:
- Dr Edward Reiter
- Phone Number: 413-794-5060
-
Principal Investigator:
- Dr Edward Reiter
-
Worcester, Massachusetts, United States, 01655
- Recruiting
- UMass Memorial Medical Center
-
Contact:
- Dr. Leslie Soyka
- Phone Number: 508-856-6289
-
Principal Investigator:
- Dr. Leslie Soyka
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospital
-
Contact:
- Dr. Finen Ugrasbul
- Phone Number: 816-234-3973
-
Principal Investigator:
- Dr. Finen Ugrasbul
-
-
New Jersey
-
Morristown, New Jersey, United States, 07962
- Recruiting
- Morristown Memorial Hospital
-
Contact:
- Dr. Lawrence Silverman
- Phone Number: 973-971-6340
-
Principal Investigator:
- Dr. Lawrence Silverman
-
-
New York
-
New Hyde Park, New York, United States, 11040
- Recruiting
- Schneider Children's Hospital
-
Contact:
- Dr. Phyllis Speiser
- Phone Number: 718-470-3290
-
Principal Investigator:
- Dr. Phyllis Speiser
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Children's Hospital Medical Centre
-
Contact:
- Dr Susan Rose
- Phone Number: 513-636-4744
-
Principal Investigator:
- Dr Susan Rose
-
-
Texas
-
Ft. Worth, Texas, United States, 76104
- Recruiting
- Cook Children's Hospital
-
Contact:
- Dr. Paul Thornton
- Phone Number: 682-885-7960
-
Principal Investigator:
- Dr. Paul Thornton
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Dr Patricia Fetchner
-
Principal Investigator:
- Dr Patricia Fetchner
-
Seattle, Washington, United States, 98122
- Recruiting
- Swedish Medical Center
-
Contact:
- Dr. Gad Kletter
- Phone Number: 206-215-2700
-
Principal Investigator:
- Dr. Gad Kletter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
ALTU-238
|
ALTU-238 0.3 mg/kg daily
ALTU-238 0.6 mg/kg daily
ALTU-238 0.9 mg/kg daily
Nutropin AQ 0.043 mg/kg daily
|
Experimental: 2
ALTU-238
|
ALTU-238 0.3 mg/kg daily
ALTU-238 0.6 mg/kg daily
ALTU-238 0.9 mg/kg daily
Nutropin AQ 0.043 mg/kg daily
|
Experimental: 3
ALTU-238
|
ALTU-238 0.3 mg/kg daily
ALTU-238 0.6 mg/kg daily
ALTU-238 0.9 mg/kg daily
Nutropin AQ 0.043 mg/kg daily
|
Active Comparator: 4
Nutropin AQ
|
ALTU-238 0.3 mg/kg daily
ALTU-238 0.6 mg/kg daily
ALTU-238 0.9 mg/kg daily
Nutropin AQ 0.043 mg/kg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
Time Frame: 26 Weeks
|
26 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
September 1, 2010
Study Registration Dates
First Submitted
February 2, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Estimate)
May 7, 2009
Last Update Submitted That Met QC Criteria
May 6, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001194
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Growth Hormone Deficiency
-
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-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyDenmark
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyGermany
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Growth Hormone Deficiency in ChildrenIsrael, Denmark, Belgium, Spain, Macedonia, The Former Yugoslav Republic of, Turkey, United Kingdom, France, Slovenia, Czech Republic
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Novo Nordisk A/SWithdrawnGrowth Hormone Disorder | Growth Hormone Deficiency in Children
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Novo Nordisk A/SCompletedHealthy | Growth Hormone Disorder | Adult Growth Hormone DeficiencyUnited States
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Novo Nordisk A/SCompletedGrowth Hormone Disorder | Growth Hormone Deficiency in Children | Delivery SystemsGermany, Netherlands, Sweden
-
OPKO Health, Inc.CompletedSafety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenPediatric Growth Hormone DeficiencyGreece, Hungary, Slovakia
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OPKO Health, Inc.CompletedAdult Growth Hormone DeficiencyCzechia, Hungary, Israel, Serbia, Slovakia, Slovenia
Clinical Trials on Somatropin
-
Xiamen Amoytop Biotech Co., Ltd.Peking Union Medical College HospitalCompleted
-
PfizerActive, not recruitingPrader-Willi SyndromeJapan
-
PfizerCompletedGrowth Hormone DeficiencyFrance
-
Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden
-
Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderJapan
-
LG ChemCompletedBioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy VolunteersKorea, Republic of
-
Novo Nordisk A/SCompletedFoetal Growth Problem | Small for Gestational AgeJapan
-
Novo Nordisk A/SCompletedAchondroplasia | Genetic DisorderJapan
-
Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden
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Novo Nordisk A/SWithdrawnHealthy | Growth Disorder