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Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan

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ClinicalTrials.gov Identifier: NCT00658879
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment
Acromegaly Drug: Somavert (Pegvisomant)

Detailed Description:
All the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

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Study Type : Observational
Actual Enrollment : 251 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Somavert -Long Term Use-
Actual Study Start Date : August 7, 2007
Actual Primary Completion Date : November 9, 2016
Actual Study Completion Date : November 9, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pegvisomant

Group/Cohort Intervention/treatment
Somavert (Pegvisomant)
Patients taking Somavert (Pegvisomant).
Drug: 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.





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A6291023 prescribes Somavert (Pegvisomant).
Criteria

Inclusion Criteria:

Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Somavert (Pegvisomant).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658879


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658879    
Other Study ID Numbers: A6291023
First Posted: April 15, 2008    Key Record Dates
Results First Posted: January 22, 2019
Last Update Posted: January 22, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases