Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is the evaluation of sustained response rate after discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or chronic pITP patients who failed one or more therapy lines, splenectomy included.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Criteria

Inclusion Criteria:

• Signed written informed consent according to ICH/EU/GCP and national local laws;

• Persistent or chronic pITP adult patients who have been treated with TPO-RAs therapy after failure of one or more therapy lines, splenectomy included;

• Age > 18 years.

Exclusion Criteria:

• Active malignancy;

• Active malignancy;

• HCVAb, HIVAb, HBsAg, HBcAb seropositive status;

• Chronic liver disease;

• Treatment with Rituximab less than 8 weeks before TPO-RAs start;

• Recent splenectomy (less than 8 weeks) before TPO-RAs start. Active malignancy;

• HCVAb, HIVAb, HBsAg, HBcAb seropositive status;

• Chronic liver disease;

• Treatment with Rituximab less than 8 weeks before TPO-RAs start;

• Recent splenectomy (less than 8 weeks) before TPO-RAs start. HCVAb, HIVAb, HBsAg, HBcAb seropositive status;

• Chronic liver disease;

• Treatment with Rituximab less than 8 weeks before TPO-RAs start;

• Recent splenectomy (less than 8 weeks) before TPO-RAs start.