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Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D

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ClinicalTrials.gov Identifier: NCT00128882
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : February 3, 2009
Sponsor:
Collaborator:
Kjaersgaard, Mimi, M.D.
Information provided by:
University of Aarhus

Brief Summary:
The purpose of this study is to describe the effect of anti-D on symptoms and platelet count in children suffering from unexplainable low platelet counts, when anti-D is administered as an injection under the skin. The hypothesis is that the injection with anti-D under the skin is as effective as anti-D given in a vein.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Drug: Anti-D Phase 2

Detailed Description:

Background:

Idiopathic thrombocytopenic purpura (ITP) in children is considered a benign hematological disease. The incidence is approximately 50 cases a year in Denmark. Approximately 25 % will experience chronic disease. Follow up and treatment of these patients is not centralized.

The drug of choice is intravenous IgG (IVIG) for treatment of ITP. The side effects are flu-like symptoms, and in rare cases aseptic meningitis. Another option is intravenous anti-D, if the child is rhesus positive. Anti-D is primarily used in North America. The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50,000/μL. Anti-D also causes flu-like symptoms. Establishing an i.v. access is a disadvantage to both IVIG and anti-D. For both treatments mechanism of action is not finally described.

Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia. It is therefore known, that immunoglobulin uptake is possible after subcutaneous administration. Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results.

IVIG treatment is expensive compared to anti-D. Treatment of a 20 kg child costs approximately 17,000 Dkr for IVIG and 2,500 Dkr. for anti-D.

Hypothesis:

  • Subcutaneous administered anti-D is as effective as IVIG/i.v. anti-D;
  • Subcutaneous administered anti-D has fewer less severe side effects than IVIG/i.v. anti-D.

Purpose:

  • To document the effect of subcutaneous anti-D;
  • Describe complications;
  • Describe aspects of the mechanism of action.

Material and Methods:

Children are eligible if admitted to a pediatric department in Denmark for diagnosis, observation or treatment of acute or chronic ITP. Examination and diagnostic work up is similar throughout the country, but not identical. No specific tests are required for diagnosis. If treatment is indicated rhesus positive children are treated with subcutaneous anti-D. Rhesus negative children are treated according to local guidelines. Specified follow-up on all children is mandatory. For research purposes one blood sample form all children is collected, and from children, who receive medical treatment, several blood samples are collected. Analysis for changes in immunological signaling peptides will be performed with special attention to the mechanism of action of anti-D.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D
Study Start Date : November 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : December 2008



Intervention Details:
  • Drug: Anti-D
    Subcutaneous injection


Primary Outcome Measures :
  1. Clinical effect evaluated on clinical score scale before and after treatment at specified intervals [ Time Frame: day 0,1,3,6,14,30, 180,360 ]

Secondary Outcome Measures :
  1. Platelet count [ Time Frame: day 0, 1, 3, 6, 14, 30, 180, 360 ]


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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic thrombocytopenic purpura (ITP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128882


Locations
Show Show 17 study locations
Sponsors and Collaborators
University of Aarhus
Kjaersgaard, Mimi, M.D.
Investigators
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Study Director: Mimi Kjaersgaard, MD University of Aarhus, Clinical Institute, Department of Pediatrics
Principal Investigator: Henrik Hasle, MD PhD Skejby Hospital, University of Aarhus, Department of Pediatrics
Additional Information:
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Responsible Party: Mimi Kjaersgaard, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT00128882    
Other Study ID Numbers: MK-2005-1
2003179
2612-2447
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009
Keywords provided by University of Aarhus:
Idiopathic Thrombocytopenic Purpura
Treatment
Anti-D
Subcutaneous
Clinical evaluation
Platelet count
IVIG
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases