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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699140
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Tracking Information
First Submitted Date  ICMJE June 16, 2008
First Posted Date  ICMJE June 17, 2008
Results First Submitted Date  ICMJE June 16, 2015
Results First Posted Date  ICMJE February 8, 2016
Last Update Posted Date February 8, 2016
Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2016)
Responder Patients [ Time Frame: At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90). ]
The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Increase of platelet count >/= 50,000/µl [ Time Frame: 5 days ]
  • Time taken for the platelet count to reach >/= 50,000/µl [ Time Frame: 21 days ]
  • The length of time the platelet count remains >/= 50,000/µl [ Time Frame: 21 days ]
  • The maximum platelet level [ Time Frame: 21 days ]
  • Regression of bleeding episodes during the first 10 or 14 days [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2016)
  • Maximum Platelet Level Reached During the Follow-up Period [ Time Frame: During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]) ]
    Platelet count was measured at various time points in the follow-up period after infusion.
  • Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days) [ Time Frame: At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]) ]
    The time taken for the platelet count to reach ≥ 50x10^9/L from first dose
  • Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days) [ Time Frame: At any time during the study period (up to 3 months [90 days]) ]
    Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)
  • Regression of Hemorrhages. [ Time Frame: First 10 to14 days since the first infusion day (Day 1) ]
    Percentage of subjects with regression of hemorrhages of Types 1 to 3:
    • Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding
    • Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses
    • Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased
    • Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)
  • Frequency of Adverse Reactions During and After Infusions by Percentage of Patients [ Time Frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) ]
    All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.
  • Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions [ Time Frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) ]
    All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.
  • Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels) [ Time Frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) ]
    Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator's judgment) was listed.
  • Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA [ Time Frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) ]
    The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels) [ Time Frame: 3 months ]
  • 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 ]
  • Nature, severity and frequency of adverse reactions during and after infusions [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
Official Title  ICMJE Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I Grifols 10% (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura
Brief Summary The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.
Detailed Description

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

  1. Increase of platelet count ≥ 50x10^9/L (primary objective).
  2. Time taken for the platelet count to reach ≥ 50x10^9/L.
  3. The length of time the platelet count remains ≥ 50x10^9/L.
  4. The maximum platelet level.
  5. Regression of bleeding episodes during the first 10 or 14 days.

To determine if IGIV3I Grifols 10% is safe with respect to:

Nature, severity and frequency of adverse reactions during and after infusions by percentage of subjects and percentage of infusions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune (Idiopathic) Thrombocytopenic Purpura
Intervention  ICMJE Biological: IGIV3I Grifols
Immune Globulin Intravenous (Human)
Other Name: IGIV
Study Arms  ICMJE Experimental: 1 treatment group with IGIV3I Grifols

Open label, non-randomized treatment group with IGIV3I Grifols

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Intervention: Biological: IGIV3I Grifols
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2016)
18
Original Actual Enrollment  ICMJE
 (submitted: June 16, 2008)
15
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≤ 20x10^9/L 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 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 alanine aminotransferase (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 hepatitis C virus (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 intravenous immune globulin (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699140
Other Study ID Numbers  ICMJE IG202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grifols Biologicals, LLC ( Instituto Grifols, S.A. )
Study Sponsor  ICMJE Instituto Grifols, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: María Teresa Álvarez, MD Hospital General Universitario La Paz
PRS Account Grifols Biologicals, LLC
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP