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The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations

7. november 2017 opdateret af: IMMUNOe Research Centers

An Investigator Driven Observational Study to Determine the Benefit of Octagam 5% for Treatment of Patients Diagnosed With Primary Immunodeficiency Disorders (PID) on Intravenous Immunoglobulin (IVIG) Therapy That Experience Adverse Events (AEs) on Any 10% IVIG Preparation

Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG solution will be changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of AEs on a lower concentration IVIG product.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being the most common form. As more 10% IVIG products are FDA approved, the older and well characterized 5% IVIG products are becoming less used. Currently, the standard of care for patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product. This study will evaluate the AEs on a 10% product and octagam 5%. The study will enroll 15 patients after an AE on any 10% product who will then be infused with octagam 5% for six infusions. AEs will be documented and compared to the 10% product along with changes in biomarkers. The study data may document another therapeutic option for patients who experience AEs - SCIG and octagam 5%.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

15

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

10 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Diagnosis of PID - specifically common variable immunodeficiency (CVID)

Beskrivelse

Inclusion Criteria:

  • Participants, or legal guardians with assent by underage children, will sign informed consent/assent and are willing to comply with all aspects of the study
  • Diagnosis of CVID according IUIS Expert Committee
  • Participants on a 10% product who experience AEs
  • Ages between 10 and 75 years of age
  • Participants on 10% IVIG therapy every 21±3 days or 28±3 days between 300 - 800 mg/Kg body weight

Exclusion Criteria:

  • Acute infection requiring antibiotic therapy within 7 days prior to visit 1
  • Presence of any condition that is likely to interfere with the evaluation of the study medication or satisfactory conduct of the trial
  • History of anaphylactic or severe systemic reactions to human immunoglobulin
  • IgA deficient patients with antibodies against IgA and a history of hypersensitivity
  • Females who are pregnant or lactating

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The change in the number of AEs post-infusion between any 10% IVIG product and octagam 5%
Tidsramme: AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change in levels of inflammatory biomarkers associated with AEs between any 10% IVIG and octagam 5%
Tidsramme: Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
Safety Evaluations (complete blood count [CBC])
Tidsramme: Screening and prior to each infusion (six infusions total) up to 24 weeks
CBC
Screening and prior to each infusion (six infusions total) up to 24 weeks
Safety evaluations (Complete Metabolic profile[CMP])
Tidsramme: Screening and prior to each infusion (six infusions total) up to 24 weeks
CMP
Screening and prior to each infusion (six infusions total) up to 24 weeks
Safety evaluations (IgG trough level)
Tidsramme: Screening and prior to last infusion up to 24 weeks
IgG trough level
Screening and prior to last infusion up to 24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

IMMUNOe Research Centers

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 (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Faktiske)

1. september 2017

Datoer for studieregistrering

Først indsendt

31. marts 2015

Først indsendt, der opfyldte QC-kriterier

7. november 2017

Først opslået (Faktiske)

13. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIS201401-PID

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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