MedTrace Logo

Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency

NCT03309891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-04-20

No results posted yet for this study

Summary

This is a randomized, open-label, active controlled, Phase 2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and semi-monthly doses of GX-H9 in the treatment of Paediatric Growth Hormone Deficiency (PGHD) as compared to the standard of care daily rhGH treatment.

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

GX-H9

subcutaneous injection (weekly or twice-monthly)

DRUG

Genotropin

subcutaneous injection (daily)

Sponsors & Collaborators

  • Genexine, Inc.

    lead INDUSTRY

Principal Investigators

  • Jungwon Woo · Genexine, Inc.

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
2016-01-18
Primary Completion
2017-10-27
Completion
2019-05-15

Countries

  • Ukraine

Study Locations

More Related Trials

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 NCT03309891 on ClinicalTrials.gov