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Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

1. april 2011 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer

An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B

This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100730
        • Pfizer Investigational Site
      • Shanghai, Kina, 200025
        • Pfizer Investigational Site
    • Guangzhou
      • Guangzhou, Guangzhou, Kina, 510515
        • Pfizer Investigational Site
    • Jiangsu
      • Suzhou, Jiangsu, Kina, 215006
        • Pfizer Investigational Site
    • Tianjin
      • Tianjin, Tianjin, Kina, 300020
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Pfizer Investigational Site

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

6 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
  • Subjects with previous exposure to FIX replacement therapy
  • If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion Criteria:

  • Diagnosed with any bleeding disorder in addition to hemophilia B
  • Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory)
  • Subject has no history of exposure to FIX products (previously untreated patient [PUP])
  • Subject is currently utilizing primary FIX prophylaxis
  • Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
  • Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
  • Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
  • Subjects with a known hypersensitivity to hamster protein
  • Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
  • Prothrombin Time >1.5 x ULN
  • Platelet count <80,000/µL
  • Pregnant or breastfeeding women
  • Unwilling or unable to follow the terms of the protocol
  • Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Benefix
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
Biologisk: Benefix
BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion
Tidsramme: 8 hours post infusion
Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.
8 hours post infusion
Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion
Tidsramme: 24 hours post infusion
Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.
24 hours post infusion
Percentage of Participants With FIX Inhibitor Development
Tidsramme: Baseline up to 6 months
Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
Baseline up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Infusions Required to Treat Each Bleed
Tidsramme: Baseline up to 6 months
The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.
Baseline up to 6 months
FIX Incremental Recovery
Tidsramme: Baseline (Visit 2) up to 6 months (Visit 4)
FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.
Baseline (Visit 2) up to 6 months (Visit 4)
Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)
Tidsramme: Baseline up to 6 months
The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.
Baseline up to 6 months
Percentage of Participants With Allergic-Type Allergic Reactions
Tidsramme: Baseline up to 6 months
Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.
Baseline up to 6 months
Percentage of Participants With Thrombosis
Tidsramme: Baseline up to 6 months
Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.
Baseline up to 6 months
Percentage of Participants With Red Blood Cell (RBC) Agglutination
Tidsramme: Baseline up to 6 months
RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.
Baseline up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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.

Generelle publikationer

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. februar 2009

Primær færdiggørelse (Faktiske)

1. december 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

19. marts 2009

Først indsendt, der opfyldte QC-kriterier

19. marts 2009

Først opslået (Skøn)

20. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. april 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2011

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3090A1-3305
  • B1821004

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 Hæmofili B

Kliniske forsøg med Benefix

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Papua New Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner