Korean Regulatory Post Marketing Surveillance for Somavert
Korean Post-marketing Surveillance for Somavert
2 other identifiers
observational
100
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2026
July 4, 2025
July 1, 2025
4.2 years
November 10, 2021
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants who experience adverse events
Baseline through 28 days after last dose (approximately 52 weeks)
Secondary Outcomes (1)
Number of participants who experience Clinical Improvement as assessed by investigator
Baseline through approximately 52 weeks
Study Arms (1)
Participants receiving Somavert
Interventions
Eligibility Criteria
Adult acromegaly patients who have had an inadequate response to surgery and/or radiation therapy and in whom appropriate medical treatment with somatostatin analogues did not normalize IGF-1 concentrations or was not tolerated
You may qualify if:
- All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.
You may not qualify if:
- Patients who are contraindicated for Somavert
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer
Seoul, 01037, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 23, 2021
Study Start
July 13, 2022
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
September 15, 2026
Last Updated
July 4, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.