Trials / Not Yet Recruiting
Not Yet RecruitingNCT07051915
The Holistic Study
Comprehensive Evaluation of Two Second-Line Therapeutic Approaches for Immune Thrombocytopenia (ITP) - a Pragmatic Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- Sponsor
- Ostfold Hospital Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a phase 3 study where eligible patients will be randomized 1:1 to one of two treatment strategies: receiving a thrombopoietin receptor agonist (Avatrombopag), or anti-CD20 (Rituximab).
Detailed description
This is a multi-center, international, open label randomized, controlled pragmatic trial consisting of 3 phases: 1. First phase extends from randomization to week 28 2. Second phase extends from week 28 to 78 3. Third phase extends from week 78 to the end of the trial (i.e. the last patient completing week 78)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avatrombopag | Daily tablets |
| DRUG | Rituximab (Arm B) | I.V. |
Timeline
- Start date
- 2025-09-15
- Primary completion
- 2028-01-31
- Completion
- 2029-12-31
- First posted
- 2025-07-04
- Last updated
- 2025-09-09
Source: ClinicalTrials.gov record NCT07051915. Inclusion in this directory is not an endorsement.