Korean Regulatory Post Marketing Surveillance for Somavert
ConditionAcromegaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPfizer
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Somavert
DrugAs provided in real world practice
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Participants receiving Somavert1 intervention
Trial outcomes
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 Source ClinicalTrials.gov