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CompletedNCT00162006Updated May 3, 2021

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

A Phase 2 interventional study of Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution in Immune Thrombocytopenic Purpura (ITP), sponsored by Baxalta now part of Shire. Completed at 11 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-03.

Sponsored by Baxalta now part of Shire · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jan 2003, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.

02

Conditions studied

  • Immune Thrombocytopenic Purpura (ITP)

Keywords

  • Chronic idiopathic thrombocytopenic purpura
03

In context

Purpura

263 studies on the registry are indexed under Purpura; 27 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 171 interventional studies indexed under Purpura.

Browse Purpura studies →

Lead sponsor

Baxalta now part of Shire is the lead sponsor of 110 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >= 18 and \<= 65 years
  • ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
  • Baseline platelet count of \<= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
  • No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
  • For females of child bearing potential, use of adequate birth control measures during study participation
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
  • Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
  • Underlying other autoimmune or lymphoproliferative disorder
  • Uncontrolled hypertension
  • Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
  • Malignancy or history of malignancy
  • Documented selective IgA deficiency (\<= 10 mg/dL)
  • Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
  • History of severe adverse reactions to blood and/or blood products
  • Pregnancy or lactation
  • Positivity for HIV, or HCV antibodies, or HBsAg
  • History of unresponsiveness to IVIG defined as a peak increment in platelet count \<= 20,000/µL coincident with the last IVIG treatment course prior to study entry
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Interventions

  • DrugImmune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
06

What researchers measure

Primary outcomes

  1. Subjects Who Qualify As Treatment Responders

    Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.

    Time frame: Baseline thru Day 15 post treatment

Secondary outcomes

  1. Time to achieve a platelet count > 50 x 109/L

    Time frame: Screening visit

  2. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 1 (initiation of treatment)

  3. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 2

  4. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 5

  5. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 8

  6. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 11

  7. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 22

  8. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 15

  9. Time to achieve a platelet count > 50 x 109/L

    Time frame: Day 29 (study termination visit)

  10. Duration of platelet response

    Time frame: Screening visit

  11. Duration of platelet response

    Time frame: Day 1 (initiation visit)

  12. Duration of platelet response

    Time frame: Day 2

  13. Duration of platelet response

    Time frame: Day 5

  14. Duration of platelet response

    Time frame: Day 8

  15. Duration of platelet response

    Time frame: Day 11

  16. Duration of platelet response

    Time frame: Day 15

  17. Duration of platelet response

    Time frame: Day 22

  18. Duration of platelet response

    Time frame: Day 29 (study termination visit)

  19. Maximum Platelet Count

    Time frame: Screening visit

  20. Maximum Platelet Count

    Time frame: Day 1 (initiation visit)

  21. Maximum Platelet Count

    Time frame: Day 2

  22. Maximum Platelet Count

    Time frame: Day 5

  23. Maximum Platelet Count

    Time frame: Day 8

  24. Maximum Platelet Count

    Time frame: Day 11

  25. Maximum Platelet Count

    Time frame: Day 15

  26. Maximum Platelet Count

    Time frame: Day 22

  27. Maximum Platelet Count

    Time frame: Day 29 (study termination visit)

  28. Number of Adverse Experiences

    Time frame: Throughout the study period of approximately 11 months

07

Study locations

11 sites
  • Brno, Czechia
  • Hradec Králové, Czechia
  • Olomouc, Czechia
  • Prague, Czechia
  • Giessen, Germany
  • Halle/Saale, Germany
  • Debrecen, Hungary
  • Györ, Hungary
  • Szeged, Hungary
  • Szombathely, Hungary
  • Lodz, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00162006
Lead sponsor
Baxalta now part of Shire
Responsible party
Sponsor
First posted
Sep 13, 2005
Start date
Jan 13, 2003
Primary completion
Dec 3, 2003
Completion
Dec 3, 2003
Last update
May 3, 2021

Study contacts

Study Director
study director · Takeda
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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