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A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency

NCT03305016 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-01-04

Study results available
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Summary

A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (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, Canada, Australia, and New Zealand.

Conditions

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

Interventions

DRUG

TransCon hGH

Once weekly subcutaneous injection at a starting dose of 0.24 mg/kg/week

Sponsors & Collaborators

  • Ascendis Pharma Endocrinology Division A/S

    lead INDUSTRY

Principal Investigators

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

  • David B Karpf, MD · Ascendis Pharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2019-03-19
Completion
2019-03-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

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 NCT03305016 on ClinicalTrials.gov