The Holistic Study
NCT07051915 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2025-09-09
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).
Conditions
- Thrombocytopenia Purpura
Interventions
- DRUG
-
Avatrombopag
Daily tablets
- DRUG
-
Rituximab (Arm B)
I.V.
Sponsors & Collaborators
-
Oslo University Hospital
collaborator OTHER -
University Hospital, Akershus
collaborator OTHER -
Sykehuset i Vestfold HF
collaborator OTHER -
St. Olavs Hospital
collaborator OTHER -
Helse Stavanger HF
collaborator OTHER_GOV -
Sorlandet Hospital HF
collaborator OTHER_GOV -
University Hospital of North Norway
collaborator OTHER -
Haukeland University Hospital
collaborator OTHER -
Helse Nord-Trøndelag HF
collaborator OTHER -
Helse Fonna
collaborator OTHER -
Nordlandssykehuset HF
collaborator OTHER -
Ostfold Hospital Trust
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-15
- Primary Completion
- 2028-01-31
- Completion
- 2029-12-31
More Related Trials
-
Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With ITP of ≤6 Months
NCT05046327 ·Status: WITHDRAWN ·Phase: PHASE3
-
An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP
NCT04943042 ·Status: COMPLETED
-
Safety and Efficacy of Eltrombopag at Escalated Doses
NCT01880047 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
NCT00828750 ·Status: COMPLETED ·Phase: PHASE3
-
Rituximab as Second Line Treatment for ITP
NCT00344149 ·Status: COMPLETED ·Phase: PHASE3
-
A Rollover Study to Provide Continued Treatment With Eltrombopag
NCT01957176 ·Status: COMPLETED ·Phase: PHASE4
-
Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)
NCT01506414 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
NCT04638829 ·Status: COMPLETED ·Phase: PHASE4
-
An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers
NCT00005570 ·Status: COMPLETED
-
Immunomodulation With Eltrombopag in ITP
NCT04812483 ·Status: COMPLETED ·Phase: PHASE2
-
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
NCT01520909 ·Status: COMPLETED ·Phase: PHASE3
-
Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP)
NCT04949009 ·Status: UNKNOWN
-
Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
NCT02614846 ·Status: UNKNOWN ·Phase: PHASE1
-
Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe
NCT06408324 ·Status: COMPLETED
-
Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)
NCT00424177 ·Status: COMPLETED ·Phase: PHASE2
-
Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
NCT04516967 ·Status: COMPLETED ·Phase: PHASE3
-
Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
NCT06281327 ·Status: RECRUITING ·Phase: PHASE2
-
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
NCT04518475 ·Status: RECRUITING ·Phase: PHASE4
-
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
NCT04737850 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
NCT04323748 ·Status: RECRUITING ·Phase: PHASE1
-
Immunomodulation With Romiplostim in Young Adults With ITP
NCT02760251 ·Status: COMPLETED ·Phase: PHASE4
-
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
NCT00102739 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)
NCT01438840 ·Status: COMPLETED ·Phase: PHASE3
-
Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia
NCT02298075 ·Status: COMPLETED
-
Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
NCT07133659 ·Status: RECRUITING ·Phase: PHASE4