Growth Hormone DeficiencyPhase 2NCT00837863
Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
A Phase 2 study testing Somatropin in people with Growth Hormone Deficiency, run by Altus Pharmaceuticals at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Children's Hospital Medical Centre
Cincinnati, Ohio, 45229
Dr Susan Rose, 513-636-4744
Dr Susan Rose
- Recruiting
Cook Children's Hospital
Fort Worth, Texas, 76104
Dr. Paul Thornton, 682-885-7960
Dr. Paul Thornton
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Dr. Finen Ugrasbul, 816-234-3973
Dr. Finen Ugrasbul
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Dr Stephen Kemp
Dr Stephen Kemp
- Recruiting
Morristown Memorial Hospital
Morristown, New Jersey, 07962
Dr. Lawrence Silverman, 973-971-6340
Dr. Lawrence Silverman
- Recruiting
Schneider Children's Hospital
New Hyde Park, New York, 11040
Dr. Phyllis Speiser, 718-470-3290
Dr. Phyllis Speiser
- Recruiting
Nemours Children's Clinic
Orlando, Florida, 32806
Dr. Jorge Daaboul, 407-650-7210
Dr. Jorge Daaboul
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Dr Patricia Fetchner
Dr Patricia Fetchner
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Dr. Gad Kletter, 206-215-2700
Dr. Gad Kletter
- Recruiting
Baystate Medical Centre
Springfield, Massachusetts, 01199
Dr Edward Reiter, 413-794-5060
Dr Edward Reiter
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Dr. Leslie Soyka, 508-856-6289
Dr. Leslie Soyka
About this study
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
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.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Somatropin
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
ALTU-238 0.3 mg/kg daily
SomatropinDrug
ALTU-238 0.6 mg/kg daily
SomatropinDrug
ALTU-238 0.9 mg/kg daily
SomatropinDrug
Nutropin AQ 0.043 mg/kg daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ALTU-238 Receives: Drug: Somatropin |
| 2 | Experimental | ALTU-238 Receives: Drug: Somatropin |
| 3 | Experimental | ALTU-238 Receives: Drug: Somatropin |
| 4 | Active comparator | Nutropin AQ Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837863
- Sponsor's protocol ID
- 0001194
- Status last verified
- May 2009
- First submitted
- 2 Feb 2009
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00837863
- Acronym / sponsor ID
- 0001194
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Altus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (estimated)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SomatropinALTU-238 |
| 2 | Experimental | Drug: SomatropinALTU-238 |
| 3 | Experimental | Drug: SomatropinALTU-238 |
| 4 | Active comparator | Drug: SomatropinNutropin AQ |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatropinALTU-238 0.3 mg/kg daily | Drug | 1 |
| SomatropinALTU-238 0.6 mg/kg daily | Drug | 2 |
| SomatropinALTU-238 0.9 mg/kg daily | Drug | 3 |
| SomatropinNutropin AQ 0.043 mg/kg daily | Drug | 4 |
Primary outcome
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
Time frame: 26 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin in people with Growth Hormone Deficiency, run by Altus Pharmaceuticals at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Kenneth Attie, Medical Monitor (781-373-6481, kattie@altus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.