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Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS

NCT04697381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-14

Study results available
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Summary

This is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of Japanese participants with PWS.

Conditions

Interventions

BIOLOGICAL

somatropin - GH naïve pediatric cohort

somatropin 0.245 mg/kg/week

BIOLOGICAL

somatropin - GH treated cohort

somatropin 0.084 mg/kg/week

BIOLOGICAL

somatropin - adult cohort

somatropin 0.084 mg/kg/week

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2022-12-06
Completion
2024-04-15

Countries

  • Japan

Study Locations

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Entities

Diseases
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 NCT04697381 on ClinicalTrials.gov