Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
NCT00837863 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2009-05-07
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.
Conditions
- Growth Hormone Deficiency
Interventions
- DRUG
-
Somatropin
ALTU-238 0.3 mg/kg daily
- DRUG
-
Somatropin
ALTU-238 0.6 mg/kg daily
- DRUG
-
Somatropin
ALTU-238 0.9 mg/kg daily
- DRUG
-
Somatropin
Nutropin AQ 0.043 mg/kg daily
Sponsors & Collaborators
-
Altus Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2010-09-30
Countries
- United States
Study Locations
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