Efficacy and Safety of IVIG-L in ITP Patients

January 30, 2006 updated by: Prothya Biosolutions

Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients

The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients with ITP will be assessed and compared with data obtained from literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies infusion, eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage.

In addition to donor selection and screening, several procedures have been included in the production process to improve viral safety.

In this clinical trial, the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature. IVIG-L will also be studied in patients with hypogammaglobulinemia.The results from both studies will be used for an application for marketing authorisation of IVIG-L in Finland and the Netherlands.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-276
        • Hematology Clinic, Medical University of Bialystok
      • Gdansk, Poland, 80-952
        • Haematology Clinic, Medical University of Gdansk
      • Lodz, Poland, 93-509
        • Clinic of Haematology, Medical University of Lodz
      • Warsaw, Poland, 00-909
        • Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy
      • Warsaw, Poland, 00-957
        • Institute of Haematology and Transfusiology
      • Warsaw, Poland, 02-097
        • Haematology Clinic, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with chronic ITP with a platelet count of about 20x109/L and at high risk of bleeding
  • Patients with chronic ITP with a platelet count of about 20x109/L, who have to undergo surgery
  • A stable clinical situation (no activity of any other disease)
  • Age at least 18 yrs
  • The patient/legally acceptable representative has signed the consent form

Exclusion Criteria:

  • The presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (SLE), rheumatoid arthritis (RA) or nephritis
  • Patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, Hepatitis, Epstein-Barr virus, Toxoplasma, HIV)
  • Massive splenomegaly
  • Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
  • Having an ongoing progressive terminal disease, including HIV infection
  • Known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin
  • Presence of conditions predisposing for bleeding: anaemia (hemoglobin < 5.5 mmol/L), renal or urogenital disease, malignant disease (with the exception of basalioma, cervix carcinoma in situ), history of intracranial or aortic aneurysm, stroke, oeso-gastro-intestinal disorders with a bleeding potential, severe hypertension (diastole > 110 mm Hg).
  • Use of corticosteroids for an acute situation within 7 days before study entry. Patients using corticosteroids prophylactically can be included
  • Splenectomy in the previous two weeks
  • Renal insufficiency (plasma creatinine > 115µmol/L)
  • Pregnancy or lactation
  • Known with insufficiency of coronary or cerebral circulation
  • IgA deficiency and anti-IgA antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The efficacy of IVIG-L
The safety of IVIG-L

Secondary Outcome Measures

Outcome Measure
To compare data on efficacy and safety of IVIG-L with data obtained from literature

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prothya Biosolutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

March 1, 2002

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

January 31, 2006

Last Update Submitted That Met QC Criteria

January 30, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB98001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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