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IGIV Study for Chronic ITP Patients Ages 3-70

NCT00511147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-06-12

Study results available
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Summary

Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count \< 150 x 10\^9/L). IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary goal of treatment is to maintain the platelet count at a hemostatic level. This study will test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic ITP.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

BIOLOGICAL

IGIV3I Grifols 10%

IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    collaborator INDUSTRY

  • Grifols Biologicals, LLC

    lead INDUSTRY

Principal Investigators

  • Ali Khojasteh, MD · Capitol Comprehensive Cancer Care Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-04-30
Completion
2014-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • India
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00511147 on ClinicalTrials.gov