EUCTR2018-000452-18-AT
Active, not recruiting
Phase 1
A phase II, open-label, prospective, single-arm, study to assess ability of eltrombopag to induce sustained remission in subjects with ITP who are refractory or relapsed after first-line steroids (TAPER)
Conditionsimmune thrombocytopeniaMedDRA version: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851MedDRA version: 22.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsREVOLADE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- immune thrombocytopenia
- Sponsor
- ovartis Pharma AG
- Enrollment
- 101
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent must be obtained prior to participation in the study
- •2\. Subjects \= 18 years old
- •3\. Subjects with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
- •4\. Platelet count \< 30×109/L and assessed as needing treatment (per physician’s discretion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 66
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 35
Exclusion Criteria
- •1\. ITP patients previously treated with any ITP second\-line therapies,
- •thrombopoietin receptor (TPO\-R) agonists for ITP, except steroids /
- •2\. Patients who relapsed more than one year after the end of first\-line
- •full course of steroid therapy
- •3\. Patients with a diagnosis of secondary thrombocytopenia
- •4\. Patients who are unable to participate in assessments/biological
- •5\. Patients who have life threatening bleeding complications per
- •investigator discretion
- •6\. Patients who had a deep vein thrombosis or arterial thrombosis in the
- •6 months preceding enrollment
Outcomes
Primary Outcomes
Not specified
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