Long-Acting Growth Hormone in Children Compared to Daily rhGH

NCT02339090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2022-12-30

Study results available
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Summary

The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

Conditions

  • Growth Disorders

Interventions

DRUG

Somavaratan

Somavaratan will be administered per dose and schedule specified in the arm description.

DRUG

rhGH

rhGH will be administered per dose and schedule specified in the arm description.

Sponsors & Collaborators

  • Versartis Inc.

    lead INDUSTRY

Principal Investigators

  • Will Charlton, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-26
Primary Completion
2017-08-23
Completion
2017-08-23

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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 NCT02339090 on ClinicalTrials.gov