Last reviewed · How we verify
Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II)
The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.
Details
| Lead sponsor | Pfizer |
|---|---|
| Status | COMPLETED |
| Enrolment | 4501 |
| Start date | Wed Jul 07 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Apr 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Renal Anemia
- Pregnancy
- Lactation
Countries
Denmark, France, Finland, Italy, Greece, Sweden, Ireland, United Kingdom, Germany, Bulgaria, Croatia, Spain