French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia

Shire

Status: Completed

Conditions: Essential Thrombocythemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01192347

SPD422-702

Details and patient eligibility

About

This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Patients aged 18 years and older.
2. High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
3. Patients who have been on second- or third-line XAGRID treatment for up to 1 month, or for whom a decision has been documented to commence second line XAGRID treatment.
4. Patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form.

Exclusion Criteria

1. Patients with a known or suspected intolerance or hypersensitivity to XAGRID, closely related compounds, or any of the stated ingredients.
2. Patients for whom there is an intention to treat with combinations of cytoreductive therapy.
3. Patients participating in a separate clinical trial where their treatment is defined by that study protocol.