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NCT00547365 · FLOW

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Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction · Source last updated 2013-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was \~1 yr.
    id
    FG000
    title
    Human Immune Globulin Intravenous (IGIV)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      death (not related to study)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with primary light-chain (AL)-associated amyloidosis that caused heart dysfunction were on study.
recruitment Details
Overall study length - 2007-2011; Location - medical clinic
Complete source fields
groups
  1. description
    The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was \~1 yr.
    id
    FG000
    title
    Human Immune Globulin Intravenous (IGIV)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      death (not related to study)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with primary light-chain (AL)-associated amyloidosis that caused heart dysfunction were on study.
recruitment Details
Overall study length - 2007-2011; Location - medical clinic

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Preserved source evidence · Not medical advice