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Immune Thrombocytopenic Purpura (ITP)Phase 2NCT00162006

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 study testing Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution in people with Immune Thrombocytopenic Purpura (ITP), run by Baxalta now part of Shire at 11 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Immune Thrombocytopenic Purpura (ITP)
What is being tested?
Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Type of treatment
Injection or infusion
How many people
28 participants
Where
11 sitesin 4 countries
Study dates
13 Jan 2003to 3 Dec 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

Czechia4 sites

  • Study site

    Brno

  • Study site

    Hradec Králové

  • Study site

    Olomouc

  • Study site

    Prague

Other trials in Czechia

Hungary4 sites

  • Study site

    Debrecen

  • Study site

    Győr

  • Study site

    Szeged

  • Study site

    Szombathely

Other trials in Hungary

Germany2 sites

  • Study site

    Giessen

  • Study site

    Halle

Other trials in Germany

Poland1 site

  • Study site

    Lodz

Other trials in Poland

About this study

Official title: Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

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.

Being tested
Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Keywords
Chronic idiopathic thrombocytopenic purpura
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immune Globulin Intravenous (Human), 10% Triple Virally Reduced SolutionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline thru Day 15 post treatment

Secondary outcomes (28)

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

    Measured: Screening visit

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

    Measured: Day 1 (initiation of treatment)

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

    Measured: Day 2

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

    Measured: Day 5

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

    Measured: Day 8

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

    Measured: Day 11

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

    Measured: Day 22

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

    Measured: Day 15

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

    Measured: Day 29 (study termination visit)

  10. Duration of platelet response

    Measured: Screening visit

  11. Duration of platelet response

    Measured: Day 1 (initiation visit)

  12. Duration of platelet response

    Measured: Day 2

  13. Duration of platelet response

    Measured: Day 5

  14. Duration of platelet response

    Measured: Day 8

  15. Duration of platelet response

    Measured: Day 11

  16. Duration of platelet response

    Measured: Day 15

  17. Duration of platelet response

    Measured: Day 22

  18. Duration of platelet response

    Measured: Day 29 (study termination visit)

  19. Maximum Platelet Count

    Measured: Screening visit

  20. Maximum Platelet Count

    Measured: Day 1 (initiation visit)

  21. Maximum Platelet Count

    Measured: Day 2

  22. Maximum Platelet Count

    Measured: Day 5

  23. Maximum Platelet Count

    Measured: Day 8

  24. Maximum Platelet Count

    Measured: Day 11

  25. Maximum Platelet Count

    Measured: Day 15

  26. Maximum Platelet Count

    Measured: Day 22

  27. Maximum Platelet Count

    Measured: Day 29 (study termination visit)

  28. Number of Adverse Experiences

    Measured: Throughout the study period of approximately 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2005 (estimated)
  2. Study start13 Jan 2003
  3. Primary completion3 Dec 2003
  4. Study completion3 Dec 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00162006
Sponsor's protocol ID
160002
Status last verified
Apr 2021
First submitted
8 Sep 2005
Last updated
3 May 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution in people with Immune Thrombocytopenic Purpura (ITP), run by Baxalta now part of Shire at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Czechia, Hungary, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects Who Qualify As Treatment Responders (time frame: Baseline thru Day 15 post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00162006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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