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: August 22, 2016
Last verified: August 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 ] [ Designated as safety issue: No ]
- Factors considered to affect the safety and/or efficacy of this drug [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- The incidence of adverse drug reactions in this surveillance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 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
|Genders 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
||August 22, 2016
||Japan: Pharmaceuticals and Medical Devices Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2016
Bone Diseases, Endocrine
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases