Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II)

September 29, 2020 updated by: Pfizer

POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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 Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • MHAT "Dr. Tota Venkova"AD
      • Montana, Bulgaria, 3400
        • MHAT "Dr. Stamen Iliev"AD
      • Pleven, Bulgaria, 5800
        • UMHAT "Georgi Stranski" EAD
      • Plovdiv, Bulgaria, 4023
        • Dutchmed Dialysis Clinic (in the building of 5 DCC)
      • Plovdiv, Bulgaria, 4027
        • MHAT Plodiv AD
      • Smolian, Bulgaria, 4700
        • MHAT "Dr. Bratan Shukerov" AD
      • Sofia, Bulgaria, 1431
        • UMHAT "Alexandrovska" EAD
      • Sofia, Bulgaria, 1233
        • Fifth MHAT EAD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"
      • Sofia, Bulgaria, 1407
        • University Hospital Lozenets
      • Sofia, Bulgaria, 1606
        • SHATPD "Prof. Ivan Mitev"EAD
      • Sofia, Bulgaria, 1709
        • DCC "Sveta Anna" Sofia
      • Varna, Bulgaria, 9010
        • Kidney center - Medical center EOOD
      • Varna, Bulgaria, 9010
        • UMHAT "Sveta Marina"EAD
  • Croatia
      • Cakovec, Croatia, 40000
        • County Hospital Cakovec
      • Dubrovnik, Croatia, 20000
        • General Hospital Dubrovnik
      • Karlovac, Croatia, 47000
        • General Hospital Karlovac
      • Labin, Croatia, 52220
        • Health Center Labin
      • Osijek, Croatia, 31000
        • University Hospital Centre Osijek
      • Sibenik, Croatia, 22000
        • General Hospital Sibenik
      • Umag, Croatia, 52470
        • Health Center Umag
      • Zagreb, Croatia, 10000
        • University Hospital Merkur
      • Zagreb, Croatia, 10000
        • University hospital centre Zagreb
  • Denmark
      • Aalborg, Denmark, 9100
        • Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital
  • Finland
      • Helsinki, Finland, 00290
        • Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala
      • Jakobstad, Finland, 68601
        • Pietarsaari Hospital Medical clinic
      • Kajaani, Finland, 87140
        • Kainuu Hospital
  • France
      • Amiens (Salouel) Cedex 1, France, 80054
        • CHU Amiens-Picardie Site Sud,, service de Nefrologie
      • Amiens (Salouel) Cedex 1, France, 80054
        • CHU Amiens-Picardie Site Sud
      • Cahors Cedex 9, France, 46005
        • Centre Hospitalier de Cahors
      • Chamalieres, France, 63400
        • Aura Auvergne Chamalières
      • Clermont Ferrand, France, 63000
        • Hospital Gabriel Montpied, Centre de Dialyse
      • Le Port Marly, France, 78560
        • 35 Nephrologie Centre Medico Chirurgical de l'Europe
      • Lille, France, 59800
        • Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge
      • Paris, France, 75014
        • AURA Paris Plaisance
      • Paris Cedex 14, France
        • Aura Notre Dame de Bon Secours
      • Toulouse Cedex 9, France, 31059
        • Hopital de Rangueil, service de nephrologie
  • Germany
      • Alsfeld, Germany, 36304
        • Nephrologische Gemeinschaftspraxis
      • Alsfeld, Germany, 36304
        • PHV Dialysezentrum Alsfeld
      • Alzey, Germany, 55232
        • MVZ DaVita Alzey GmbH
      • Arnstadt, Germany, 99310
        • Gemeinschaftspraxis Dr. Gööck & Dr. Anger
      • Bad Bevensen, Germany, 29549
        • MVZ Bad Bevensen
      • Bad Homburg, Germany, 61352
        • Nephrologische Gemeinschaftspraxis
      • Bad König, Germany, 64732
        • Nephrologsiche Praxis
      • Bad Nauheim, Germany, 61231
        • Internistische Praxis und Nephrologie
      • Bad Wildungen, Germany, 34537
        • Nieren-und Hochdruckzentrum
      • Berlin, Germany, 12627
        • Praxis F. Nierenkrankheiten/Tagesklinik
      • Berlin, Germany, 13051
        • Gesundheitszentrum HSH
      • Berlin, Germany, 13125
        • Alwall-Haus Dialysezentrum Berlin
      • Berlin, Germany, 14193
        • Dialyse am Kurfürstendamm
      • Darmstadt, Germany, 64295
        • Dialyse Centrum Darmstadt
      • Dormagen, Germany, 41540
        • MVZ DaVita Dormagen GmbH
      • Essen, Germany, 45136
        • KfH Nierenzentrum
      • Frankenthal, Germany, 67227
        • Praxis für Nephrologie
      • Heppenheim, Germany, 64646
        • Nierenzentrum Heppenheim
      • Herne, Germany, 44623
        • Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
      • Herzberg, Germany, 04916
        • DaVita Elsterland
      • Homberg/Efze, Germany, 34576
        • Dialyse T. Menzer Homberg-Efze
      • Hoyerswerda, Germany, 02977
        • Nephrologische Gemeinschaftspraxis und Dialysezentrum
      • Hürth-Hermülheim, Germany, 50354
        • Gemeinschaftspraxis Grahl und Johnen
      • Kaiserslautern, Germany, 67655
        • Westpfalz-Klinikum Kaiserslautern
      • Kiel, Germany, 24106
        • Nieren- und Hochdruckzentrum Kiel
      • Kleve, Germany, 47533
        • Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH
      • Köln, Germany, 50937
        • Praxis Marsen
      • Langenfeld, Germany, 40764
        • Praxis Dres. Schoenwald und Beck
      • Langenselbold, Germany, 63505
        • Nephrologische Praxis
      • Leverkusen, Germany, 51373
        • Nierenzentrum Leverkusen
      • Ludwigslust, Germany, 19288
        • Dialysezentrum Ludwigslust
      • Luebeck, Germany, 23562
        • Nephrologische Gemeinschaftspraxis
      • Lüdenscheid, Germany, 58515
        • Märkische Kliniken GmbH Klinikum Lüdenscheid
      • Magdeburg, Germany, 39108
        • Dialysezentrum Stadtfeld
      • Mayen, Germany, 56727
        • Nephrologische Praxis
      • Mettmann, Germany, 40822
        • Nephrologisches Zentrum
      • Mühlhausen, Germany, 99974
        • Nephrologische Gemeinschaftspraxis
      • Nettetal, Germany, 41334
        • MVZ DaVita Viersen GmbH
      • Neustadt, Germany, 67433
        • ze:ro Dialysezentren und Gemeinschaftspraxis
      • Niebüll, Germany, 25899
        • Nephrologisches- und Dialysezentrum Niebüll
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann
      • Quedlinburg, Germany, 06484
        • Dialysezentrum
      • Saarlouis, Germany, 66740
        • Gemeinschaftspraxis Schuerfeld Moeller Henrich
      • Solingen, Germany, 42653
        • Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin
      • Tangermünde, Germany, 39590
        • Dialysezentrum Tangermünde
      • Wiesbaden, Germany, 65191
        • Deutsche Klinik fuer Diagnostik Department of Nephrology
  • Greece
      • Agioi Apostoloi, Greece, 851 00
        • General Hospital of Rhodes
      • Agios Nikolaos, Crete, Greece, 721 00
        • General Hospital of Agios Nikolaos
      • Agrinio, Greece, 30100
        • Private physician
      • Aigaleo, Greece, 12243
        • Office of Eleni Stefanopoulou/Private Physician
      • Alexandroupoli, Greece, 681 00
        • University General Hospital of Alexandroupoli
      • Athens, Greece, 10682
        • Polikliniki Athinon
      • Athens, Greece, 113 62
        • Therapeutical Department "ATTIKO"
      • Athens, Greece, 115 27
        • General Hospital Gennimata
      • Athens, Greece, 115 28
        • General Hospital "Alexandra"
      • Athens, Greece, 11526
        • Errikos Ntinan Hospital
      • Athens, Greece, 11526
        • Kyanos Stavros
      • Athens, Greece, 11528
        • Aretaiion Hospital
      • Athens, Greece, 124 62
        • General University Hospital "ATTIKO"
      • Athens, Greece, 151 27
        • General Hospital of Athens "A.Fleming"
      • Athens, Greece, 15235
        • Private physician
      • Chania, Crete, Greece, 733 00
        • General Hospital of Chania
      • Didimoticho, Greece, 683 00
        • Didimoticho General Hospital
      • Drama, Greece, 661 00
        • Drama General Hospital
      • Edessa, Greece, 582 00
        • Edessa General Hospital
      • Filiates, Greece, 463 00
        • General Hospital of Filiates
      • Grevena, Greece, 511 00
        • General Hospital of Grevena
      • Kavala, Greece, 655 00
        • Kavala General Hospital
      • Komotini, Greece, 691 00
        • General Hospital of Komotini Sismanogleio
      • Kozani, Greece, 50100
        • Private physician
      • Kyparissia, Greece, 245 00
        • General Hospital of Kyparissia
      • Lamia, Greece, 35100
        • Private physician
      • Larisa, Greece, 413 34
        • General University Hospital of Larisa
      • Larisa, Greece, 41335
        • General Clinic Eftichios Patsidis
      • Mesologgi, Greece, 30200
        • General Hospital of Mesologgi
      • Nea Raidestos, Thessaloniki, Greece, 57001
        • Private physician
      • Patra, Greece, 26 335
        • General Hospital Agios Andreas
      • Ptolemaida, Greece, 502 00
        • General Hospital of Prolemaida
      • Serres, Greece, 621 00
        • Serres general Hospital
      • Thessaloniki, Greece, 564 29
        • Papageorgiou General Hospital
      • Thessaloniki, Greece, 546 36
        • Ahepa University Hospital
      • Thessaloniki, Greece, 546 39
        • Ippokrateion General Hospital
      • Thessaloniki, Greece, 54642
        • Private physician
      • Thessaloniki, Greece, 56224
        • Private physician
      • Thessaloniki, Greece, 56431
        • Private physician
      • Thessaloniki, Greece, 570 01
        • "Diavalkaniko" Therareutical Center
      • Thessaloniki, Greece, 570 01
        • Therapeutical Department of Thermi
      • Thessaloniki, Greece, 570 10
        • Papanikolaou General Hospital
      • Veria, Greece, 59100
        • Private physician
      • Volos, Greece, 38221
        • Thessaliki Nosileutiki EPE
      • Voula, Greece, 166 75
        • Private physician
      • Voula, Greece, 16673
        • Private physician
    • Attiki
      • Voula, Attiki, Greece, 166 73
        • General Hospital "Asklipeiio Voulas"
  • Ireland
      • Galway, Ireland
        • Merlin Park Dialysis Unit
  • Italy
      • Ancona, Italy, 60020
        • U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti
      • Anzio (RM), Italy, 00042
        • Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH
      • Arezzo, Italy, 52100
        • Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo
      • Ascoli Piceno, Italy, 63100
        • Dipartimento di Nefrologia- Ospedale Mazzoni
      • Aversa (NA), Italy, 80031
        • P.O. S.G. Moscati
      • Chieri (TO), Italy, 10023
        • OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi
      • Firenze, Italy, 50134
        • AOU Careggi Hospital Firenze
      • Grosseto, Italy, 58100
        • Ospedale della Misericordia USL9
      • Lido Di Camaiore (Lucca), Italy, 55043
        • Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)
      • Lucca, Italy, 55100
        • U.O. Nefrologia Lucca
      • Mestre, Italy, 30174
        • U.O. Nefrologia e Dialisi ULSS12
      • Milano, Italy, 20126
        • Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale
      • Naples, Italy, 80131
        • Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica
      • Napoli, Italy, 80100
        • A.O. MONALDI- Dept nephrology and Dialysis
      • Napoli, Italy, 80131
        • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"
      • Nocera Inferiore (SA), Italy, 84014
        • ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI
      • Nola (NA), Italy, 80035
        • Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI
      • PISA (Cisanello), Italy, 56124
        • UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa
      • Padova, Italy, 35128
        • Dipartimento di Medicina -DIMED- Policlinico Padova
      • Pavia, Italy, 27100
        • Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,
      • Pistoia, Italy, 51100
        • U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"
      • San Sebastiano, Italy, 81100
        • U.O.C. Nefrologia e Dialisi Azienda Ospedaliera
      • Siena, Italy, 53100
        • U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese
      • Torino, Italy, 10126
        • A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto
      • Torino, Italy, 10141
        • Ospedale Martini - S.C. Nefrologia E Dialisi
      • Torino, Italy, 10154
        • Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi
    • Avellino
      • Sant'Angelo dei Lombardi, Avellino, Italy, 83054
        • Presidio ospesdaliero G.CRISCUOLI - UO DIALISI
    • Bergamo
      • Zingonia- Osio Sotto, Bergamo, Italy, 24040
        • Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi
    • CE
      • Santa Maria Capua Vetere, CE, Italy, 81055
        • Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi
    • Catanzaro
      • Soverato, Catanzaro, Italy, 88068
        • "Presidio Ospedaliero" di Soverato - Servizio Dialisi
    • Ferrara
      • Cona-Ferrara, Ferrara, Italy, 44124
        • Azienda Ospedaliera S. Anna
    • Pisa
      • San Miniato, Pisa, Italy, 56027
        • U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli
  • Spain
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Barcelona, Spain, 08034
        • Hospital de Barcelona
      • Leon, Spain, 24071
        • Hospital Universitario de Leon
      • Madrid, Spain, 28003
        • Hospital central della Cruz Roja
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Sabadell, Spain, 08208
        • Hospital Parc Tauli
      • Zamora, Spain, 49022
        • Hospital Virgen de la Concha
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
    • Málaga
      • Benalmadena, Málaga, Spain, 29630
        • Xanit Hospital Internacional
    • Valencia
      • Xativa, Valencia, Spain, 46800
        • Hospital Lluis Alcanyis
  • Sweden
      • Karlskoga, Sweden, 69181
        • Karlskoga Lasarett
      • Linköping, Sweden, 58185
        • Linkopings Universitetssjukhus
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital
      • Stockholm, Sweden, 18288
        • Njurmedicinska kliniken, Danderyds sjukhus
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.

Description

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 3 years of observation

Exclusion Criteria:

  • Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Single group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence Rate of Adverse Events of Special Interest
Time Frame: 156 weeks
Ongoing routine doctor visits for 156 weeks
156 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse drug reactions
Time Frame: 156 weeks
Descriptive evaluation including incidence rates of adverse drug reactions.
156 weeks
Information on treatment with Retacrit during pregnancy and lactation
Time Frame: 156 weeks
156 weeks
Data on long term use
Time Frame: 156 weeks
156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPOE-09-11
  • C1111006 (Other Identifier: Alias Study Number)
  • PASCO II (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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