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

NCT00128882 | Completed Phase 2 DMC

• 3 other identifiers: MK-2005-120031792612-2447
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 17

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.

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

Idiopathic Thrombocytopenic Purpura; Treatment; Anti-D; Subcutaneous; Clinical evaluation; Platelet count; IVIG

Outcome Measures

Primary Outcomes (1)

• Clinical effect evaluated on clinical score scale before and after treatment at specified intervals

  day 0,1,3,6,14,30, 180,360

Secondary Outcomes (1)

• Platelet count

  day 0, 1, 3, 6, 14, 30, 180, 360

Interventions

Anti-D DRUG

Subcutaneous injection

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Idiopathic thrombocytopenic purpura (ITP)

Sponsors & Collaborators

• University of Aarhus: lead
• Kjaersgaard, Mimi, M.D.: collaborator

Study Sites (17)

Aalborg University Hospital, Department of Pediatrics

Aalborg, 9100, Denmark

Location

Skejby Hospital, Aarhus University Hospital, Department of Pediatrics

Aarhus N, 8200, Denmark

Location

Amager Hospital, Department of Pediatrics

Copenhagen S, 2300, Denmark

Location

Rigshospitalet, Copenhagen University Hospital, Pediatric Clinic II

Copenhagen Ø, 2100, Denmark

Location

Esbjerg Hospital, Department of Pediatrics

Esbjerg, 6700, Denmark

Location

Gentofte Hospital, Department of Pediatrics

Gentofte Municipality, 2900, Denmark

Location

Herning Hospital, Department of Pediatrics

Herning, 7400, Denmark

Location

Hjoerring Hospital, Department of Pediatrics

Hjørring, 9800, Denmark

Location

Holbæk Hospital, Department of Pediatrics

Holbæk, 4300, Denmark

Location

Hvidovre Hospital, Department of Pediatrics

Hvidovre, 2650, Denmark

Location

Kolding Hospital Department of Pediatrics

Kolding, 6000, Denmark

Location

Nykøbing F, Department of Pediatrics

Nykøbing Falster, 4800, Denmark

Location

Næstved Hospital, Department of Pediatrics

Næstved, 4700, Denmark

Location

Odense University Hospital

Odense C, 5000, Denmark

Location

Randers Hospital, Department of Pediatrics

Randers, 8900, Denmark

Location

Sønderborg Hospital, Department of Pediatrics

Sønderborg, 6400, Denmark

Location

Viborg Hospital, Department of Pediatrics

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

RHO(D) antibody

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Mimi Kjaersgaard, MD

  University of Aarhus, Clinical Institute, Department of Pediatrics

  STUDY DIRECTOR

• Henrik Hasle, MD PhD

  Skejby Hospital, University of Aarhus, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 10, 2005
• Study Start: November 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 3, 2009

Record last verified: 2009-02

Locations

DK (17)