Study of ianalumab with eltrombopag in immune thrombocytopenia (ITP) patients who did not respond to steroid treatment
- Conditions
- Health Condition 1: D694- Other primary thrombocytopenia
- Registration Number
- CTRI/2023/05/052406
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1a.Male or female patients aged 18 years and older on the day of signing the informed consent.
2a.A signed informed consent must be obtained prior to participation in the study.
3a.A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
4. Platelet count <30 G/L and assessed need for treatment (per physician’s discretion).
1.ITP patients who received second-line ITP treatments (other than corticosteroid therapy ± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max. one week) before screening are eligible.
2.Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia
3.Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
4.Patients with current or history of life-threatening bleeding
5.Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive
6.Patients with known active or uncontrolled infection requiring systemic treatment during screening period
7.Patients with hepatic impairment
8.Patients with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication
9.Female patients who are pregnant or nursing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Treatment Failure (TTF)Timepoint: Time to Treatment Failure (TTF)
- Secondary Outcome Measures
Name Time Method