Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

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Brief Title

Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

Official Title

IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients

Brief Summary

      The objective of this study is to determine if the safety and tolerability of Immune Globulin
      Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at
      two different infusion rates. The primary objective is to compare the incidence and severity
      of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14
      mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
    

Detailed Description

      This is a prospective, single blind, randomized, multi-center cross-over trial in patients
      with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune
      Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed
      individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any
      subject with an established dose in the range of 200-399 mg/kg will be assigned to receive
      400 mg/kg during the course of the study during the same dosing schedule established prior to
      entry into the study.

      After a screening period lasting not more than four weeks, patients will be randomized into
      one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C,
      10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min,
      whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min
      on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients
      just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as
      calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema
      below.

      Group 1:

        -  Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)

        -  Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)

      Group 2:

        -  Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)

        -  Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Infusion related adverse events

Secondary Outcome

 All adverse events

Condition

Immunologic Deficiency Syndrome

Intervention

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

Study Arms / Comparison Groups

 Group 1
Description:  Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

August 2002

Completion Date

March 2004

Primary Completion Date

August 2002

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of primary immune deficiency and medical records available for
             retrospective review for at least 3 months prior to entry into the trial

          -  Signed an informed consent written informed consent prior to initiation of any study
             related procedures

          -  Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of
             200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the
             trial. Patients who are currently receiving less than 400 mg/kg are eligible for this
             trial and will be at the time of study enrollment be treated at 400 mg/kg

        Exclusion Criteria:

          -  History or suspicion of significant allergic reaction to intravenous immune globulin,
             and/or blood products

          -  Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and known
             antibodies to IgA

          -  Isolated IgG subclass deficiency with a normal total serum IgG level

          -  Other conditions which may interfere with the trial, include the patients demeanor or
             mental ability to follow instruction.

          -  Pretreatment with anti-pyretics or anti-histamines

          -  Congestive heart failure (New York Heart Association stage greater than Class II)

          -  Renal insufficiency (creatinine >2.5 mg/dL)

          -  Conditions whose symptoms and effects could alter protein catabolism and/or IgG
             utilization (e.g. protein-losing enteropathies, nephrotic syndrome)

          -  Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse
             events (AEs)

          -  Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain
             adequate trough levels

          -  Women of child bearing potential who do not practice adequate contraception (i.e.
             chemical or mechanical methods) and pregnant or lactating females
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Erwin Gelfand, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00220766

Organization ID

100348



Study Sponsor

Grifols Therapeutics LLC


Study Sponsor

Erwin Gelfand, MD, Principal Investigator, National Jewish Medical and Research Center, Denver, CO


Verification Date

September 2009