Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: April 9, 2008
Last updated: December 19, 2016
Last verified: December 2016
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
||Observational Model: Case-Only
Time Perspective: Prospective
||Special Investigation Of Somavert -Long Term Use-
Primary Outcome Measures:
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) [ Time Frame: 5 years ]
- Factors considered to affect the safety and/or efficacy of this drug [ Time Frame: 5 years ]
- The incidence of adverse drug reactions in this surveillance [ Time Frame: 5 years ]
Secondary Outcome Measures:
- This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes measures. [ Time Frame: There is no secondary outcomes for this surveillance. ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||November 2016 (Final data collection date for primary outcome measure)
Patients taking Pegvisomant.
Pegvisomant 10, 15 or 20mg powder and solvent for solution for injection.
Dosage, Frequency : According to Japanese LPD.
Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration.
All the patients whom an investigator prescribes the first Pegvisomant should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
|Ages Eligible for Study:
||Child, Adult, Senior
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
The patients whom an investigator involving A6291023 prescribes the Pegvisomant.
Patients need to be administered Pegvisomant in order to be enrolled in the surveillance.
Patients not administered Pegvisomant.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00658879
||Pfizer CT.gov Call Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 9, 2008
||December 19, 2016
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 20, 2017
Bone Diseases, Endocrine
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases