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Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

NCT03831880 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2021-10-14

Study results available
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Summary

This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who have been stable on treatment with daily Genotropin will be enrolled.

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

Genotropin

Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily

DRUG

somatrogon

0.66 mg/kg/week given subcutaneously once weekly

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-08-28
Completion
2020-08-28
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT03831880 on ClinicalTrials.gov