Dynepo Long-Term Safety Study

• Status: Terminated
• Trial end date: 2008-07-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

1. Patients who complete Dynepo study SPD490-301.

2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.

Exclusion Criteria:

1. Withdrawal, before Week 24, from study SPD490-301.

2. Pregnant or lactating women.

3. Uncontrolled hypertension.

4. Thrombocytopenia (platelet count <75,000/mm3).

5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).

6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.

7. Androgen therapy in the 30 days immediately prior to enrolment in this study.

8. Known Human Immunodeficiency Virus (HIV) infection.

9. History of hypersensitivity to Dynepo.

10. Known to have Ab against EPO.