A Study to Evaluate the Efficacy and Safety of Inj. Romiplostim of Intas Pharmaceuticals Ltd. in Adult Indian Patients with Idiopathic Thrombocytopenic Purpura.
- Conditions
- Immune thrombocytopenic purpura,
- Registration Number
- CTRI/2015/09/006197
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Romiplostim is a novel thrombopoiesis-stimulatingprotein that has been developed as a treatment for adults with thrombocytopeniaassociated with ITP. Romiplostim provides an effective approach for thetreatment of ITP. As demonstrated in two multicentre, placebo-controlled, PhaseIII studies, Romiplostim robustly maintains platelet counts at clinicallymeaningful levels in both splenectomised and non-splenectomised patients, ascompared to patients receiving only standard of care ITP medications, withresponse rates generally better than those medications. Romiplostimhas been approved globally including US, EU, Canada, Australia etc since 2008.Romiplostim has not yet approved in India. Also, India was not the part ofInnovator’s Global clinical trial programme. Hence, safety and efficacy ofRomiplostim is unproven in Indian Population. Intas Pharmaceuticals hasdeveloped biosimilar Romiplostim, which is similar to Innovator’s product interms for chemical and preclinical characteristics. Aim of the current study isto evaluate the efficacy and safety of Intas Romiplostim in Indian population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
- Male and Female patients aged between 18 to 65 years (both inclusive) 2.
- Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 12months before enrolment4 3.
- Have completed at least 1 prior treatment for ITP 4.
- Value of platelet count must be: (i) less than 30000/μL for those patients not receiving any ITP therapy (ii) less than 50000/μL for those patients receiving a constant dose schedule of corticosteroids 5.
- Written informed and signed consent 6.
- Patient must be able to adhere to the study visit schedule, understand, and comply with all protocol requirements.
- History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder 2.
- Positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus 3.
- Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit 4.
- Received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (e.g., immunosuppressants etc) within 1 week before the screening visit 5.
- Received hematopoietic growth factors (e.g., granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the screening visit 6.
- Received any monoclonal antibody (e.g., rituximab) within 8 weeks before the screening visit or anticipated use during the time of the proposed study 7.
- Less than 2 months since major surgery 8.
- Any other condition that in the opinion of investigator could hamper participation in the study 9.
- Previous participation in any clinical trial within 1 month before the entry of the study 10.
- Pregnant or breast feeding 11.
- Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving platelet response (Platelet response is defined as a platelet count at a scheduled weekly visit of 50000/μL or more and double the platelet count from baseline in the absence of rescue medication within the 8 weeks.) Baseline to week 8
- Secondary Outcome Measures
Name Time Method •Dose required to achieve targeted platelet count (50000/μL) •Proportion of patients with at least one dose increment
Trial Locations
- Locations (8)
Apollo Speciality Hospital
🇮🇳Chennai, TAMIL NADU, India
Artemis Hospitals
🇮🇳Gurgaon, HARYANA, India
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Institute of Hematology and Transfusion Medicine
🇮🇳Kolkata, WEST BENGAL, India
N.R.S. Medical College & Hospital
🇮🇳Kolkata, WEST BENGAL, India
Rajiv Gandhi Cancer Institute & Research Centre
🇮🇳West, DELHI, India
Sahyadri Speciality Hospital
🇮🇳Pune, MAHARASHTRA, India
St. Johns Medical College& Hospital
🇮🇳Bangalore, KARNATAKA, India
Apollo Speciality Hospital🇮🇳Chennai, TAMIL NADU, IndiaDr Jose M EasowPrincipal investigator09841700827joseeasow@yahoo.com