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OpenTrials
Completed

NCT Number: NCT05131100

Korean Regulatory Post Marketing Surveillance for Somavert

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)

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Patients who are contraindicated for Somavert

Treatment and study plan

Somavert

Drug

As provided in real world practice

Primary outcomes

  1. Number of participants who experience adverse events

    Time frame: Baseline through 28 days after last dose (approximately 52 weeks)

Secondary outcomes

  1. Number of participants who experience Clinical Improvement as assessed by investigator

    Time frame: Baseline through approximately 52 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

KOREAN POST-MARKETING SURVEILLANCE FOR SOMAVERT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.