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A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency

NCT03145831 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-03-09

No results posted yet for this study

Summary

This study is a multi-center, open-label safety study assessing long-term somavaratan administration.

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

Somavaratan

All subjects will receive somavaratan 3.5 mg/kg twice monthly (every 15 days ± 2 days). Administered as a subcutaneous bolus injection.

Sponsors & Collaborators

  • Versartis Inc.

    lead INDUSTRY

Principal Investigators

  • Will Charlton, MD · Vesrartis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-11-30
Completion
2017-11-30

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 NCT03145831 on ClinicalTrials.gov