CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
somatropin - GH naïve pediatric cohort +2 morebiological
Likely dose
somatropin - GH naïve pediatric cohort 0.245 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04697381
NCT04697381Phase 3Completed
CompareCT.gov

A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS)

Pfizer·interventional·Posted Jan 6, 2021·Updated Jan 14, 2026

In Brief

A Phase 3 clinical trial evaluating somatropin - GH naïve pediatric cohort, somatropin - GH treated cohort, and 1 other intervention for Prader-Willi Syndrome. Completed, enrolled 33 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJan 6, 2021
Enrollment StartFeb 9, 2021
Primary CompletionDec 6, 2022
Study CompletionApr 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.5 years ago

Interventions

somatropin - GH naïve pediatric cohortbiological

somatropin 0.245 mg/kg/week

somatropin - GH treated cohortbiological

somatropin 0.084 mg/kg/week

somatropin - adult cohortbiological

somatropin 0.084 mg/kg/week