ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 100000004851
Conditions
Interventions
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Current
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both genders 2. Age between 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the active substance or to any of the excipients. 2. Patient with IgA deficiency except if the absence of anti IgA antibodies is documented. 3. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, or severe hypertension (systolic blood pressure > or = to160 mmHg and diastolic blood pressure > or = to 100 mmHg). 4. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months in patients aged 2 x upper limit of normal range, alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 3 x upper limit of normal range. 14. Prior episode of renal insufficiency or creatinine clearance values < 80 ml/min/1.73 m2 before inclusion (Modified Diet in Renal Disease calculation). 15. Medical history of haemolysis or haemolytic anaemia during prior IVIg therapy or any other concomitant disease of clotting system (i.e. haemophilia). 16. Administration of another investigational medicinal product within the last month. 17. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient to comply with the protocol requirements. 18. Pregnant with positive results pregnancy urinary test or breastfeeding woman, or woman of childbearing potential without effective contraception (effective contraception are: injectable, patch or combined oral estro-progestative or progestative contraceptives, intra-uterine devices of type 'copper T' and levonorgest releasing IU systems, depot intramuscular medroxyprogesteron, s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of I10E in increasing platelet count and controlling bleedings in patients suffering from primary Immune ThrombocytoPenia (ITP).;Secondary Objective: To assess the biological and clinical safety profile of I10E.;Primary end point(s): The primary endpoint is the number and percentage of patients with responses (including complete responses) during the investigational period. Patients with response (R): - Platelet counts > or = to 30 x 10 exp9/l and at least 2-fold increase of baseline platelet count confirmed on at least 2 separate visits at least 7 days apart. - And absence of new bleeding. · Patients with complete response (CR): - Platelet count > or = to 100 x 10 exp9/l, confirmed on at least 2 separate visits at least 7 days apart. - And absence of new bleeding.;Timepoint(s) of evaluation of this end point: confirmed on at least 2 separate visits at least 7 days apart during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy criteria: - Number and % of patients with complete response (CR) during the investigational period. - Time to response i.e. time from starting treatment to time of platelet response achievement (platelet count > or = to 30 x 10 exp9/l) in the responder population. - Maximum platelet counts and time to reach the maximum platelet count. - Number and % of non-responders patients (NR) during the investigational period. - Number and % of patients with a loss of R and CR during the investigational period. - Duration of response defined as the number of days from the first day of the response (CR or R) to the first day of the loss of response (CR or R). - Number and % of patients with platelet count > or = to 50 x 10 exp9/l at Day 5, Day 6 and Day 7. - Evaluation of pre-existing bleedings (Khellaf score and WHO score assessed at baseline, Day 2, Day 14 and Day 30);Timepoint(s) of evaluation of this end point: see details provided in section E 5.2. | — |
Countries
France, Germany, Hungary, Italy, Poland, Russian Federation, Spain, Ukraine
Contacts
Public ContactClinical trial information desk
LFB BIOTECHNOLOGIES
Outcome results
None listed