CTRI/2021/08/035609
Not yet recruiting
Phase 4
A prospective, single-arm, multicentre study to assess safety and efficacy of Romy�® (Romiplostim Powder for Injection) (Intas Pharmaceuticals Ltd., India) in patients with chronic refractory immune (idiopathic) thrombocytopenic purpura (ITP)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Intas Pharmaceuticals Limited
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with confirmed chronic immune thrombocytopenia (lasting more than 6 months since diagnosis) as diagnosed by the investigator who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
- •Note:\- Patients with ongoing ITP medications (corticosteroids, immunoglobulin, danazol, and azathioprine) at a constant dose and schedule at the time of screening will be eligible.
- •2\.Patients aged more than or equal to 1 year
- •3\.Value of platelet counts taken during screening must be,
- •Ã¢â?¬Â¢Less than 30 in to 10 raised to 9 per L for those patients not receiving ITP therapy.
- •Ã¢â?¬Â¢Less than 50 in to 10 raised to 9 per L for those patients receiving stable dose of ongoing ITP medication.
- •4\.Patients in good health as determined by past medical history, physical examination, vital signs (heart rate, blood pressure, respiratory rate and body temperature), ECG and laboratory tests at screening.
- •5\.Written informed consent/assent from participants or legally acceptable representative (as applicable) must be obtained before any assessment is performed.
- •6\.Adequate hematologic, renal, and liver function during screening:
- •Ã¢â?¬Â¢Hemoglobin greater than 10\.0 g/dL
Exclusion Criteria
- •1\.Patients who does not have increased risk of bleeding though having thrombocytopenia
- •2\.Patients having thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP.
- •3\.History of immunodeficiency diseases, including a positive HIV test result.
- •4\.Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •5\.Patients with any clinical condition (other than chronic immune thrombocytopenia) or drug intake that increases the risk for bleeding.
- •6\.History of hypersensitivity to the study drug or any recombinant Escherichia coli derived product.
- •7\.Less than 8 weeks since major surgery (including laparoscopic splenectomy)
- •8\.Any condition that in the opinion of investigator could affect the safety of patient participating in the study.
- •9\.Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half\-lives of enrolment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •10\.Pregnant or lactating mother.
Outcomes
Primary Outcomes
Not specified
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