- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00658879
Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
SPECIAL INVESTIGATION OF SOMAVERT -LONG TERM USE-
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered Somavert (Pegvisomant).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Somavert (Pegvisomant)
Patients taking Somavert (Pegvisomant).
|
Somavert (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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly.
Relatedness to Somavert was assessed by the physician.
|
5 years
|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
Expectedness of the adverse event was determined according to the Japanese package insert.
Relatedness to Somavert was assessed by the physician.
|
5 years
|
Number of Participants With Treatment-Related Adverse Events by Gender
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
Relatedness to Somavert was assessed by the physician.
Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
5 years
|
Number of Participants With Treatment-Related Adverse Events by Age
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
Relatedness to Somavert was assessed by the physician.
Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
5 years
|
Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
Relatedness to Somavert was assessed by the physician.
Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
5 years
|
Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
Relatedness to Somavert was assessed by the physician.
Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
5 years
|
Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
Time Frame: 5 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert.
Relatedness to Somavert was assessed by the physician.
Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
5 years
|
Clinical Effectiveness Rate
Time Frame: 5 years
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician.
Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
|
5 years
|
Clinical Effectiveness Rate by Gender
Time Frame: 5 years
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician.
Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.
|
5 years
|
Clinical Effectiveness Rate by Age
Time Frame: 5 years
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician.
Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.
|
5 years
|
Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
Time Frame: 5 years
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician.
Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness.
|
5 years
|
Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
Time Frame: 5 years
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician.
Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness.
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6291023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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