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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837863 on ClinicalTrials.gov