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A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

NCT02781727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2022-01-04

Study results available
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Summary

A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States.

Conditions

  • Growth Hormone Deficiency, Pediatric
  • hGH (Human Growth Hormone)
  • Endocrine System Diseases
  • Hormones
  • Pituitary Diseases

Interventions

DRUG

Once weekly subcutaneous injection of TransCon hGH

Once weekly subcutaneous injection

DRUG

Once daily subcutaneous injection of Genotropin

Once daily subcutaneous injection

Sponsors & Collaborators

  • Ascendis Pharma Endocrinology Division A/S

    lead INDUSTRY

Principal Investigators

  • Michael Beckert, MD · Ascendis Pharma A/S

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2019-01-17
Completion
2019-01-17

Countries

  • United States
  • Armenia
  • Australia
  • Belarus
  • Bulgaria
  • Georgia
  • Greece
  • Italy
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Turkey (Türkiye)
  • 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 NCT02781727 on ClinicalTrials.gov