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

Pfizer

Status: Completed

Conditions: Acromegaly

Treatments: Drug: Somavert (Pegvisomant)

Study type: Observational

Funder types: Industry

Identifiers

NCT00658879

A6291023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 251 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients not administered Somavert (Pegvisomant).

Trial design

251 participants in 1 patient group

Somavert (Pegvisomant)

Description:

Patients taking Somavert (Pegvisomant).

Treatment:

Drug: Somavert (Pegvisomant)