Korean Regulatory Post Marketing Surveillance for Somavert

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05131100
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 49

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: Somavert

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Korean Post-marketing Surveillance for Somavert
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Aug 2, 2026
• Anticipated Study Completion Date: Sep 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Participants receiving Somavert	Drug: Somavert; As provided in real world practice

Outcome Measures

Primary Outcome Measures

1. Number of participants who experience adverse events [Baseline through 28 days after last dose (approximately 52 weeks)]

Secondary Outcome Measures

1. Number of participants who experience Clinical Improvement as assessed by investigator [Baseline through approximately 52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05131100
• Other Study ID Numbers: A6291047
• First Posted: Nov 23, 2021
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: acromegaly, Somavert, Post-Marketing Surveillance
• Additional relevant MeSH terms: Acromegaly

Study Results

No Results Posted as of Jul 19, 2022