The study is to check the safety and effectiveness of romiplostim in patients suffering from severe purple discoloration of skin due to low platelets.
- Conditions
- Health Condition 1: D693- Immune thrombocytopenic purpura
- Registration Number
- CTRI/2023/05/053181
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1) Male and Female subject in between 18 to 65 years of age.
2) Patients with chronic immune (idiopathic) thrombocytopenic purpura. per the American Society of Hematology guidelines.
3) If subject is > 60 years of age, subject had a written bone marrow biopsy report consistent with a diagnosis of ITP.
4) Subject had received at least 1 prior therapy for ITP.
5)Subject with a single platelet count less than equal to 30 x 10 raise to 9/L at any time during the screening period.
6) Subject (or legally - acceptable representative) was willing and able to
provide written informed consent.
1) Known hypersensitivity to romiplostim or any of its excipients.
2) Subject had a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell
disorder.
3) Subjects with known history of congenital thrombocytopenia, systemic lupus erythematosus, Evans syndrome, autoimmune neutropenia,
antiphospholipid antibody syndrome, positive for lupus anticoagulant, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
4) Subjects with known history of infection with H. pylori.
5) Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any
platelet producing agent.
6) Subject has a known hypersensitivity to any recombinant E coli-derived product.
7) Subjects suffering from chronic liver disease (Child-Pugh score more than or equal to 7).
8) Subjects with history of any thromboembolic disease.
9) Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator.
10) Subject is pregnant or breast feeding.
11) Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method