Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO 11) (PASCO II)
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Purpose
This is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with RetacritTM (epoetin zeta) administered subcutaneously in patients with renal anaemia.
| Condition |
|---|
|
Renal Anemia Pregnancy Lactation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO 1I) |
- Incidence rate of adverse events [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]Ongoing routine doctor visits for 156 weeks
- Adverse drug reactions [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]Descriptive evaluation including incidence rates of adverse drug reactions. Information on treatment with Retacrit (epoetin zeta)during pregnancy and lactation and on long term use.
Biospecimen Retention: Samples Without DNA
Pre-dose serum samples
| Estimated Enrollment: | 6700 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Single group |
Detailed Description:
To estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with RetacritTM (epoetin zeta) administered subcutaneously in patients with renal anaemia.
To obtain information on adverse drug reactions (ADR)associated with RetacritTM (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.
Inclusion Criteria:
- Patients currently under treatment with Retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia.
- Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.
- Patients expected to be available for up to 3 years of observation
Exclusion Criteria:
- Any contraindications as per the current SPC (section 4.3) of Retacrit™
Contacts and Locations| Contact: Heather Fowler, PhD | +44 (0) 1204 845 246 | heather.fowler@hospira.com |
| Contact: Caty Ebel-Bitoun, MD | +44 (0) 1926 834 425 | caty.ebelbitoun@hospira.com |
Show 65 Study Locations More Information
No publications provided
| Responsible Party: | Hospira, Inc. |
| ClinicalTrials.gov Identifier: | NCT01543477 History of Changes |
| Other Study ID Numbers: | EPOE-09-11 |
| Study First Received: | February 21, 2012 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Finland: Finnish Medicines Agency France: Conseil National de l'Ordre des Médecins France: The Commission nationale de l’informatique et des libertés Germany: Federal Institute for Drugs and Medical Devices Ireland: Irish Medicines Board Italy: The Italian Medicines Agency Portugal: National Pharmacy and Medicines Institute Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Bulgaria: Bulgarian Drug Agency Greece: National Drug Organization |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013