This is a clinical study to evaluate efficacy and safety of human normal immunoglobulin for intravenous administration in adult patients with chronic primary immune thrombocytopenia.
- Conditions
- Health Condition 1: D696- Thrombocytopenia, unspecified
- Registration Number
- CTRI/2023/07/055259
- Lead Sponsor
- Intas Pharmaceuticals Limited, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply.
(1) Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study as described in this protocol and is willing to participate in the study.
(2) Male or female participant must be greater than18 years of age at the time of signing the informed consent.
(3) Participant who are medically stable on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participants source documents and initialed by the investigator.
(4) Participant who are medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology and urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participants source documents and initialed by the investigator.
(5) Participant with documented diagnosis of chronic primary immune thrombocytopenia (ITP) (lasting greater than 12 months since diagnosis) based on the American Society of Hematology Criteria. In addition, following is required, Documented medical history of a peripheral blood smear examination that supports the diagnosis of ITP with no evidence of other causes of thrombocytopenia (e.g. pseudothrombocytopenia, myelofibrosis), Participant should have isolated thrombocytopenia in the blood count apart from thrombocytopenia, the blood count is normal for the participants age, or if abnormal, readily explained. • The physical examination should not suggest any disease which may cause thrombocytopenia other than ITP.,• Participant in the need of treatment(s) with IVIg either with bleeding manifestations or without bleeding manifestations to minimize the risk of bleeding considered as clinically significant by the investigator based on current practice guideline at the time of screening.
(6) Participant has a platelet count measurement during screening (two separate counts at least 1 day apart during the screening period) and at baseline (Day 1) with an average of the three platelet counts less than 30×10 to the power 9 per L and no single count must be greater than 35×10 to the power 9 per L (using local laboratory). (Note,
If a participant is rescreened, all screening laboratory tests must be repeated.)
(7) Participant with or without splenectomy (splenectomy will count as one type of previous treatment) and both Rh(D) plus and Rh(D) minus participants can be included.
(8) If participant is currently being treated with corticosteroids, the treatment regimen or dose must stable for a minimum of 2 weeks before Day 1. Participant must remain on a stable treatment regimen throughout the study period. If there is any intent to increase the corticosteroid dose before end of study visit, participant will be excluded in the study.
(9) Participant is currently being treated with cyclosporin, mycophenolate mofetil, azathioprine or attenuated androgens like danazol, the treatment regimen and dose must have bee
Any potential participant who meets any of the following criteria will be excluded from participating in the study.
(1) Participant with history of aseptic meningitis syndrome, myeloproliferative disorder or bone marrow stem cell disorder, severe renal impairment defined as dependence on the dialysis or has a history of acute renal failure or does not meet screening serum creatinine values defined for the study, any other clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
(2) Participants with secondary immune thrombocytopenia due to any cause including but not
limited to, hematological malignancy like leukemia, lymphoma, lymphoproliferative disorders, multiple myeloma, common variable immune deficiency, drugs (e.g., quinine, heparin), thyroid disease, cirrhosis, HIV infection, hepatitis C, systemic lupus erythematosus and antiphospholipid antibody syndrome, etc. Note, Participant with a positive test for anti-nuclear antibodies (ANA) and antiphospholipid antibodies (APLA) including anticardiolipin and lupus anticoagulant at screening can be included in the clinical studies providing they do not have any clinical manifestation of SLE or antiphospholipid syndrome according to investigator.
(3) Presence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia including but not limited to, • Multi-lineage immune cytopenia, such as Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis), autoimmune pancytopenia. • Myelodysplastic syndrome, autoimmune hemolytic anemia, acquired immunodeficiency syndrome, etc. • Participant exhibit an identifiable alternative cause of their thrombocytopenia, such as splenomegaly, family thrombocytopenia, bacteremia, sepsis or active infection requiring therapy or not will also be excluded.
(4) An abnormal (positive) direct Coombs test in participants who have not received IVIg or
IV anti-D immunoglobulin within 30 days.
(5) Participant having contraindication for intravenous immunoglobulin or has been diagnosed
previously with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated Immunoglobulin A (IgA) deficiency with known anti-IgA antibodies. Serum Ig (IgG, IgA,
IgM) at screening will be assessed.
(6) Participant with known allergies, hypersensitivity, or intolerance to corn or its excipients.
(7) Participant with a history of severe hypersensitivity or anaphylactic reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to blood or any blood-derived product, or any severe reaction to IVIg or any other IgG preparation.
(8) • Administration of intravenous immunoglobulin (IVIg), anti-D immunoglobulin within
3 weeks prior to Day 1. • Has received recombinant human thrombopoietin (rhTPO), thrombopoietin receptor agonists like romiplostim, splenic tyrosine kinase inhibitors like fostamatinib within 4 weeks prior to Day 1. • Alkylating agents like cyclophosphamide within 8 weeks prior to Day 1 or anticipated use during the time of the proposed study. • Splenectomy within 4 weeks prior to Day 1 or planned splenectomy throughout the study period. • Participant has received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to Day 1. • Participant has received any blood, blood product, or blood derivative within
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of human normal immunoglobulin in adult <br/ ><br>participants with chronic primary immune thrombocytopenia (ITP).Timepoint: Day -14 to -1 1,2,3,4,5,6,7,8, 15, 22, 29
- Secondary Outcome Measures
Name Time Method Safety of human normal <br/ ><br>immunoglobulin in adult participants with chronic primary ITP.Timepoint: During treatment.;To characterize the effects of <br/ ><br>human normal immunoglobulin in adult participants with chronic primary immune thrombocytopenia (ITP).Timepoint: two separate occasions, at least <br/ ><br>7 days