- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00398749
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)
5. november 2012 opdateret af: Janssen-Cilag B.V.
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2
The main purpose of this study is to evaluate the safety and efficacy (% response) of epoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer.
Studieoversigt
Detaljeret beskrivelse
Anemia has been identified as a common complication and a widespread problem in the cancer population.
Anemia is a condition in which a patient has below normal levels of hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body.
People with severe anemia may experience fatigue and shortness of breath with activity.
Therefore, this condition can have a negative influence on a person's quality of life.
Epoetin alfa, used to treat anemia in cancer patients, is a genetically engineered protein that stimulates red blood cell production.
This study investigates treatment of anemia using epoetin alfa during chemotherapy in adult patients with cancer.
The study is intended to collect information on normal medical practice and routine anemia management performed at the participating centers.
This is an observational, non-randomized, prospective, comparative, parallel-group survey performed in The Netherlands.
Patients with various severities of disease may enter the survey as soon as their epoetin alfa treatment starts and will be followed until the end of their epoetin alfa treatment.
Patient data are collected in Case Report Forms (CRFs) until 4 weeks after the end of treatment with epoetin alfa.
At the end of treatment completed CRFs will be collected.
The assessment of effectiveness/response will be based on the following: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of blood transfusions, and serum iron levels and iron supplementation.
Safety evaluations include the incidence of serious and non-serious adverse events.
Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1927
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Cancer patients receiving epoetin alfa as anemia treatment during chemotherapy, as part of the common practice of participating physicians.
Patients may enter the study as soon as their epoetin alfa treatment starts.
Beskrivelse
Inclusion Criteria:
- Patients with a diagnosis of solid tumors, multiple myeloma (Kahlers' disease), non-Hodgkin lymphoma or Hodgkins' disease
- Patients must already be receiving chemotherapy or start their first cycle within a week of enrollment
- Patients must receive epoetin alfa treatment (expected treatment duration is at least 4 weeks)
Exclusion Criteria:
- Patients who cannot read the Dutch language and/or do not understand the Dutch Informed Consent Form and patients participating in either of our observational studies, EVALUATE or COMPARE
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Epoetin alfa
Epoetin alfa 40 000 IU once weekly variable treatment length
|
40,000 IU once weekly, variable treatment length
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The assessment of effectiveness based on: epoetin alfa treatment schedule (dose and timing), hemoglobin effect, response to treatment (independent of blood transfusion), mean time to response, # of blood transfusions given, and iron supplementation
Tidsramme: 4 weeks, 8 weeks and end of treatment
|
4 weeks, 8 weeks and end of treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of adverse events
Tidsramme: from start epoetin treatment to end of study
|
from start epoetin treatment to end of study
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2005
Primær færdiggørelse (Faktiske)
1. november 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
10. november 2006
Først indsendt, der opfyldte QC-kriterier
10. november 2006
Først opslået (Skøn)
14. november 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR005596
- EPOCAN4018
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Neoplasmer
-
Guangzhou First People's HospitalAfsluttet
Kliniske forsøg med Epoetin alfa
-
Hospital de Clinicas de Porto AlegreOswaldo Cruz Foundation; Rio Grande do Sul State Health Department - SES...AfsluttetSammenligning af effektiviteten af to formuleringer af epoetin hos patienter, der gennemgår hæmodialyse
-
MegalabsAzidus LaboratoriesIkke rekrutterer endnuAnæmi af kronisk nyresygdomUruguay
-
M.D. Anderson Cancer CenterAfsluttet
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Afsluttet
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet
-
Johnson & Johnson Pharmaceutical Research & Development...AfsluttetBlodtransfusion | Ortopædkirurgi | Ortopædiske procedurer | Mammaplastik | Kardiovaskulære kirurgiske procedurer | Blodtransfusion, autolog
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet
-
Johnson & Johnson Pharmaceutical Research & Development...Afsluttet
-
Hoffmann-La RocheAfsluttet
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.AfsluttetAnæmi | Surgery, Arthroscopy