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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00658879
First received: April 9, 2008
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Acromegaly
Drug: Pegvisomant
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Somavert (Pegvisomant) - Long Term Use - (Regulatory Post Marketing Commitment Plan).

Resource links provided by NLM:


Further study details as provided by Pfizer:

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: 1000
Study Start Date: August 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pegvisomant
Patients taking Pegvisomant.
Drug: 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.


Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A6291023 prescribes the Pegvisomant.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Pegvisomant.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658879

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658879     History of Changes
Other Study ID Numbers: A6291023
Study First Received: April 9, 2008
Last Updated: July 21, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 26, 2014