MedPath

Korean Regulatory Post Marketing Surveillance for Somavert

Recruiting
Conditions
Acromegaly
Interventions
Registration Number
NCT05131100
Lead Sponsor
Pfizer
Brief Summary

Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria

All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.

Read More
Exclusion Criteria

Patients who are contraindicated for Somavert

Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Participants receiving SomavertSomavert-
Primary Outcome Measures
NameTimeMethod
Number of participants who experience adverse eventsBaseline through 28 days after last dose (approximately 52 weeks)
Secondary Outcome Measures
NameTimeMethod
Number of participants who experience Clinical Improvement as assessed by investigatorBaseline through approximately 52 weeks

Trial Locations

Locations (1)

Pfizer

🇰🇷

Seoul, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath