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A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

26. februar 2013 opdateret af: Bio Products Laboratory

A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura

To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a published data.

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

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico
      • Buenos Aires, Argentina, C1122AAL
        • I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
      • Buenos Aires, Argentina, C1431FWO
        • Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado de Cordoba
      • Corrientes, Argentina
        • J.R. Vidal Hospital
      • San Juan, Argentina, 5400
        • CER San Juan
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1437JCP
        • Hospital Churruca
      • La Plata, Buenos Aires, Argentina, B1900AXU
        • Hospital Italiano de La Plata
    • Sante Fe
      • Rosario, Sante Fe, Argentina, S2000JKR
        • Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
  • Forenede Stater
    • Florida
      • Orange City, Florida, Forenede Stater, 32763
        • Mid Florida Hematology & Oncology
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
        • Center for Cancer & Blood Disorders
    • New York
      • New York, New York, Forenede Stater, 10021
        • New York Hospital / Cornell University, Division of Pediatrics
      • Stony Brook, New York, Forenede Stater, 11794-8111
        • Department of Pediatrics, SUNY at Stony Brook
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Cancer Care Centers of South Texas
  • Indien
      • New Delhi, Indien, 110060
        • Sir Ganga Ram Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien, 500003
        • Apollo Hospitals
      • Hyderabad, Andhra Pradesh, Indien, 500054
        • Mahavir Hospital
      • Suryarao pet, Vijayawada, Andhra Pradesh, Indien, 520002
        • City Cancer Centre,
    • Bangalore
      • Karnataka, Bangalore, Indien, 560054
        • M. S Ramaiah Hospital
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380009
        • Vedanta
      • Ahmedabad, Gujarat, Indien, 380061
        • Gurukrupa Hospital
      • Gokal Nagar, Karamsad, Gujarat, Indien, 388325
        • M S Patel Cancer Centre, Shree Krishna Hospital
    • Karnataka
      • Bangalore, Karnataka, Indien, 560017
        • Manipal Hospital
      • Mangalore, Karnataka, Indien, 575002
        • Father Muller Medical College Hospital
      • Mangalore, Karnataka, Indien, 5750003
        • Vinaya Hospital & research Centre
      • Mangalore, Karnataka, Indien, 575001
        • Kasturba Medical College, Manipal Acunova KMC Research Centre
    • Maharashtra
      • Pune, Maharashtra, Indien, 411004
        • Deenanath Mangeshkar Hospital
    • Rajasthan
      • Jaipur, Rajasthan, Indien, 300201
        • S.K. Soni Hospital Sect 5

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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Males and females aged between 18 and 70 years.
  2. Confirmed diagnosis of chronic ITP of at least 6 months duration.
  3. Platelet count of less than or equal to 20 x 10 9/L at enrollment.
  4. Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
  5. If subjects were treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 6) If subjects were being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before Day 1. The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 7) Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.

8) The subject has signed an informed consent form (subjects must be at least 18 years old), and/or the subject's legal guardian has signed the informed consent form if indicated 9) If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.

10) If a subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.

Exclusion Criteria:

  1. A history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IGIV or any other IgG preparation.
  2. Intolerance to any component of the investigational product.
  3. Received any live virus vaccine within the last 3 months prior to Day1.
  4. Received an IGIV preparation within 1 month prior to Day 1.
  5. Were currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
  6. Received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
  7. Received Rituximab within the 3 months before Day 1.
  8. Pregnant or nursing.
  9. Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
  10. Had levels greater than 2.5 times the upper limit of normal at screening, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
  11. Had severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); on dialysis; a history of acute renal failure.
  12. Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
  13. History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
  14. Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
  15. Suffered from any acute or chronic medical conditions (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study.
  16. An acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1 x 109/L).
  17. Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
  18. Anemic (hemoglobin <10 g/dL) at screening.
  19. Unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gammaplex (intravenous immunoglobulin)
Biologisk: Gammaplex, intravenous immunoglobulin

Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).

The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.

Andre navne:
  • Gammaplex

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
Tidsramme: 9 days
The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.
9 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Safety of GAMMAPLEX at the Dosage Used in This Study.
Tidsramme: AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.

The safety variables used to assess safety were the following:

  • Adverse events

    • The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops
    • Nature, severity, and frequency of AEs
    • Suspected unexpected serious adverse reactions (SUSARs)
  • Vital signs
  • Clinical laboratory tests and Direct Coombs' Test
  • Transmission of viruses
  • Physical examination
AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.
Tidsramme: Days 1, 2, 3, 5, 9, 14, 21, 32.
Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.
Days 1, 2, 3, 5, 9, 14, 21, 32.

Samarbejdspartnere og efterforskere

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

Sponsor

Bio Products Laboratory

Efterforskere

  • Ledende efterforsker: Tim J Aldwinckle, MD, Bio Products Laboratory

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

Hjælpsomme links

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. september 2007

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

18. juli 2007

Først indsendt, der opfyldte QC-kriterier

18. juli 2007

Først opslået (Skøn)

19. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GMX02

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 .

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