Korean Regulatory Post Marketing Surveillance for Somavert
- 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.
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Exclusion Criteria
Patients who are contraindicated for Somavert
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants receiving Somavert Somavert -
- Primary Outcome Measures
Name Time Method Number of participants who experience adverse events Baseline through 28 days after last dose (approximately 52 weeks)
- Secondary Outcome Measures
Name Time Method Number of participants who experience Clinical Improvement as assessed by investigator Baseline through approximately 52 weeks
Trial Locations
- Locations (1)
Pfizer
🇰🇷Seoul, Korea, Republic of