Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I Grifols 10% (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura

Instituto Grifols, S.A.7 sites in 3 countries18 target enrollmentFebruary 2008

ConditionsImmune (Idiopathic) Thrombocytopenic Purpura

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Immune (Idiopathic) Thrombocytopenic Purpura
Sponsor: Instituto Grifols, S.A.
Enrollment: 18
Locations: 7
Primary Endpoint: Responder Patients
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

December 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Instituto Grifols, S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be aged between 18 and 82 at the time of written consent.
•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.
•To show a platelet count platelet count ≤ 20x10\^9/L at the moment of the first infusion with the study product.

Exclusion Criteria

•Have immune thrombocytopenia secondary to other pathologies or drug mediated thrombocytopenia.
•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.
•Present important active bleeding due to other reasons apart from the ITP.
•Exhibit an identifiable alternative cause of their thrombocytopenia, such as splenomegaly, family thrombocytopenia, bacteraemia, sepsis or active infection requiring or not therapy.
•Are presenting renal dysfunction.
•Have non-controlled arterial hypertension.
•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.
•Are presenting a cardiac disease including a history of coronary artery disease, angina pectoris or congestive heart failure.
•Present known infection due to HIV or hepatitis C virus (HCV).
•Have been previously treated with IVIG or anti-D immunoglobulin being unresponsive.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)(At any time during the study period (up to 3 months [90 days]))
Maximum Platelet Level Reached During the Follow-up Period(During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]))
Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)(At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]))
Regression of Hemorrhages.(First 10 to14 days since the first infusion day (Day 1))
Frequency of Adverse Reactions During and After Infusions by Percentage of Patients(At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up))
Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions(At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up))
Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)(At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up))
Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA(At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up))