The Holistic Study
ConditionThrombocytopenia Purpura
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOstfold Hospital Trust
About this trial
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).
Eligibility criteria
Qualifiers
Male or female aged ≥18 years.
Diagnosis of primary ITP of less than one-year duration and having a platelet count of < 30 x109/L measured within two weeks prior to inclusion with failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects.
Clinical need for subsequent platelet elevating therapy assessed by the physician in charge.
Signed and dated written informed consent.
Disqualifiers
Previous treatment for ITP with: Rituximab, other immune suppressants (including mycophenolate mofetil, azathioprine, cyclosporine), dapsone, danazol, chemotherapy (apart from vincristine as rescue therapy) or splenectomy. Short treatment with any thrombopoietic agent is allowed if given for a limited duration of a maximum of 2 weeks as rescue therapy for quick elevation of platelet count in emergency situations e.g. bleeding.
Pregnancy or lactation.
Females of child-bearing potential refusing to follow effective contraceptive methods for at least 12 months following the last administration of Rituximab or during treatment with Avatrombopag.
Secondary ITP: ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders: Systemic Lupus Erythematosus, Antiphospholipid Syndrome, or Common Variable Immune Deficiency; ITP secondary the following viral infections: Human Immunodeficiency Virus or Hepatitis C Virus.
Trial design
Treatments tested in this trial
- Avatrombopag
- Rituximab (Arm B)
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Ostfold Hospital Trust
Lead sponsor
Oslo University Hospital
Collaborator
University Hospital, Akershus
Collaborator
Sykehuset i Vestfold HF
Collaborator
St. Olavs Hospital
Collaborator
Helse Stavanger HF
Collaborator
Sorlandet Hospital HF
Collaborator
University Hospital of North Norway
Collaborator
Haukeland University Hospital
Collaborator
Helse Nord-Trøndelag HF
Collaborator
Helse Fonna
Collaborator
Nordlandssykehuset HF
Collaborator
Source ClinicalTrials.gov