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A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial

NCT03344458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2024-05-08

Study results available
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Summary

A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.

Conditions

  • Growth Hormone Deficiency, Pediatric
  • Endocrine System Diseases
  • Hormone Deficiency
  • Pituitary Diseases

Interventions

DRUG

TransCon hGH

Once weekly subcutaneous injection of TransCon hGH

Sponsors & Collaborators

  • Ascendis Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Michael Beckert, MD · Ascendis Pharma A/S

  • Aimee D Shu, MD · Ascendis Pharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2023-02-21
Completion
2023-02-21
FDA Drug
Yes

Countries

  • United States
  • Armenia
  • Australia
  • Belarus
  • Bulgaria
  • Georgia
  • Greece
  • New Zealand
  • Poland
  • Russia
  • Ukraine

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 NCT03344458 on ClinicalTrials.gov