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Korean Regulatory Post Marketing Surveillance for Somavert

KOREAN POST-MARKETING SURVEILLANCE FOR SOMAVERT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05131100
Enrollment
11
Registered
2021-11-23
Start date
2022-07-13
Completion date
2025-11-10
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

acromegaly, Somavert, Post-Marketing Surveillance

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)

Interventions

DRUGSomavert

As provided in real world practice

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants who experience adverse eventsBaseline through 28 days after last dose (approximately 52 weeks)

Secondary

MeasureTime frame
Number of participants who experience Clinical Improvement as assessed by investigatorBaseline through approximately 52 weeks

Countries

South Korea

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026