Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura (ITP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Grifols Biologicals Inc.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00699140
First received: June 16, 2008
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether IGIV3I 10% Grifols is effective in the treatment of immune thrombocytopenic purpura.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Biological: IGIV3I Grifols
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I 10% Grifols (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura

Resource links provided by NLM:


Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Increase of platelet count >/= 50,000/µl and regression of bleeding episodes. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Nature, severity and frequency of adverse reactions during and after infusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Frequency of responders (platelet count >/= 50,000/µl [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Time to reach platelet count >/= 50,000/µl [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Length of time platelet count remains ./= 50,000/µl. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]
  • Regression of hemorrhages. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Open label, non-randomized
Biological: IGIV3I Grifols
Immune Globulin Intravenous (Human)
Other Name: IGIV

Detailed Description:

To determine if IGIV3I 10% Grifols is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:

  1. Increase of platelet count > 50,000/µl (primary objective).
  2. Time taken for the platelet count to reach > 50,000/µl.
  3. The length of time the platelet count remains > 50,000/µl.
  4. The maximum platelet level.
  5. Regression of bleeding episodes during the first 10 or 14 days.

To determine if IGIV3I Grifols is safe with respect to:

  1. Nature, severity and frequency of adverse reactions during and after infusions.
  2. Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels).
  3. Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function.
  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be aged between 18 and 82 at the time of written consent.
  2. Have confirmed diagnosis of chronic ITP and fulfil all the following criteria:

    • irrelevant history except for the symptoms of bleeding,
    • pattern of bleedings associated with platelet disorders,
    • physical examination irrelevant for the ITP, except for the signs of bleeding,
    • isolated thrombocytopenia in the blood count; apart from thrombocytopenia, the blood count is normal for the patient's age, or if abnormal, readily explained,
    • peripheral blood smear consistent with ITP: thrombocytopenia with platelets of normal size or slightly larger than normal, with absence of platelet clumps and giant platelets; normal red blood cell and white blood cell morphology,
    • confirmed diagnosis of immune thrombocytopenic purpura or, when any abnormal finding is present, additional diagnostic evaluation excludes other causes of thrombocytopenia.
    • Previous known diagnosis of ITP for at least 3 months.
  3. To show a platelet count platelet count < 30,000/µl at the moment of the first infusion with the study product.
  4. Have read the patient information and consent sheet, agreed to participate in the trial, and signed the consent sheet.
  5. Be expected to receive treatment over 5 days and follow-up for 3 months.
  6. For women of childbearing age, use adequate contraceptive method such as oral contraceptives, intrauterine device (IUD) or tubal ligation during one-month period after the first infusion in the study.

Exclusion Criteria:

  1. Have immune thrombocytopenia secondary to other pathologies or drug mediated thrombocytopenia.
  2. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  3. Present important active bleeding due to other reasons apart from the ITP.
  4. Exhibit an identifiable alternative cause of their thrombocytopenia, such as splenomegaly, family thrombocytopenia, bacteraemia, sepsis or active infection requiring or not therapy.
  5. Are presenting renal dysfunction.
  6. Have non-controlled arterial hypertension.
  7. Have documented liver cirrhosis or any hepatic disorder with ALT levels 2.5 times or more than the normal upper limit or bilirubin greater than 2 mg/dl.
  8. Are presenting a cardiac disease including a history of coronary artery disease, angina pectoris or congestive heart failure.
  9. Present known infection due to HIV or HCV.
  10. Have been previously treated with IVIG or anti-D immunoglobulin being unresponsive.
  11. Have a history of serious adverse reactions or non-serious but frequent adverse reactions to IVIG preparations or other products derived from blood.
  12. Have known allergies to any IGIV3I Grifols components, such as D-sorbitol.
  13. Are simultaneously participating in other clinical studies or have received an investigational drug in the 3 months prior to the start of the study.
  14. Have been involved in the present study and being treated with the formulation at 5% (IGIV3I Grifols 5%).
  15. Have conditions that might affect patient compliance.
  16. Are unable to provide a storage serum sample just before the first dose of IGIV3I Grifols.
  17. Are pregnant or nursing an infant child or unwilling to practice adequate birth control in 1-month period after the first infusion in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699140

Locations
Russian Federation
Haematology Research Centre of Russian Academy of Medical Science Completed
Moscow, Russian Federation
Botkin City Clinical Hospital Completed
Moscow, Russian Federation
Spain
Hospital de Bellvitge Completed
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau Completed
Barcelona, Spain
Hospital General Vall d´Hebron Completed
Barcelona, Spain
. Hospital de León Completed
Leon, Spain
Hospital General Universitario La Paz Completed
Madrid, Spain
Hospital Universitario de Salamanca Completed
Salamanca, Spain
Hospital Universitario La Fe Completed
Valencia, Spain
United Kingdom
University College of London Recruiting
London, United Kingdom, NW1 2PG
Contact: S Machin, MD    0845 155 5000 ext 9884      
Principal Investigator: M Machin, MD         
Hillingdon Hospital Recruiting
Middlesex, United Kingdom, UB8 3NN
Contact: Richard Kaczmarkski, MD       r.kaczmarski@imperial.ac.uk   
Principal Investigator: Richard Kaczmarski, MD         
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: T Nokes, MD       Tim.Nokes@phnt.swest.nhs.uk   
Principal Investigator: T Nokes, MD         
Sponsors and Collaborators
Grifols Biologicals Inc.
Investigators
Study Chair: Antonio Julia, MD Hospital General Vall Hebron
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc.
ClinicalTrials.gov Identifier: NCT00699140     History of Changes
Other Study ID Numbers: IG-202
Study First Received: June 16, 2008
Last Updated: March 18, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on October 30, 2014