Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Romy�® (Romiplostim Powder for Injection): Strength- 250 microgram lyophilized powder vial or 500 microgram lyophilized powder vial
Dose- 1 microgram/kg
Frequency- once weekly
Duration- 24 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion 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, � Less than 30 in to 10 raised to 9 per L for those patients not receiving ITP therapy. � 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: � Hemoglobin greater than 10.0 g/dL � Serum creatinine less than or equal to 1.5 in to the upper limit of normal (ULN) � Total serum bilirubin less than or equal to 1.5 in to the ULN � Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 in to the UL 7. Subjects legally acceptable representative or subject (if applicable) is able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion criteria
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. 11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using acceptable methods of contraception during the study and for at least 3 months following last study drug administration. 1. Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural amenorrhea with an appropriate clinical profile or six months of amenorrhea with serum FSH level more than 40 mIU/ml; or have had surgical bilateral oophorectomy at least 6 months ago. 12. Fertile males, defined as all males physiologically capable of conceiving offspring, unless the subjects agree to comply with effective contraceptive methods for the entire duration and refrain from fathering a child during the study and for at least 3 months following last study drug administration. 13. Significant illness within two weeks prior to initial dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety of Intas Romiplostim Powder for Injection in the patients with chronic ITPTimepoint: Incidence of adverse events during 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Intas Romiplostim Powder for Injection in the patients with chronic ITPTimepoint: ââ?¬Â¢ A durable platelet response is the achievement of a weekly platelet count more than or equal to 50 in to 109/L for any 6 of the last 8 weeks of the 24-week treatment period in the absence of rescue medication at any time. ââ?¬Â¢ A transient platelet response was the achievement of any weekly platelet counts more than or equal to 50 in to 109/L for any 4 weeks during the treatment period without a durable platelet response. | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd.
Outcome results
None listed