Thrombocytopenia PurpuraPhase 3NCT07051915
The Holistic Study
A Phase 3 study testing Avatrombopag and Rituximab (Arm B) in people with Thrombocytopenia Purpura, run by Ostfold Hospital Trust.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia Purpura
- What is being tested?
- Avatrombopag and Rituximab (Arm B)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Concomitant autoimmune hemolytic anemia.
- Active hepatitis B virus (positive HBsAg). Patients with HBsAg negative and HBV core antigen antibody positive (HBcAb) should accept to receive entecavir (Baraclude) for 12 months if they will be allocated to Rituximab. Monthly HBV DNA monitoring will be required while on treatment and for the 6 months after the last dose of the study drug.
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- Presence of any serious comorbidity where the condition may worsen by and of the study drugs.
- Known allergy, sensitivity or contraindication to Rituximab or Avatrombopag.
- Patients in a severely immune compromised state.
- Presence of active malignancy unless deemed cured by adequate treatment. Participants with the following neoplastic conditions can be included:
- Monoclonal gammopathy of undetermined significance (MGUS) or monoclonal B lymphocytosis of undetermined significance (MBUS).
- Basal/squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (TNM stage T1a or T1b).
- Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
About this study
Official title: Comprehensive Evaluation of Two Second-Line Therapeutic Approaches for Immune Thrombocytopenia (ITP) - a Pragmatic Randomized Controlled 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).
Read the detailed description
This is a multi-center, international, open label randomized, controlled pragmatic trial consisting of 3 phases:
- First phase extends from randomization to week 28
- Second phase extends from week 28 to 78
- Third phase extends from week 78 to the end of the trial (i.e. the last patient completing week 78)
- Conditions
- Thrombocytopenia Purpura
- Being tested
- Avatrombopag, Rituximab (Arm B)
- Keywords
- Avatrombopag, Rituximab, Thrombocytopenia, Immune thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Daily tablets
Rituximab (Arm B)Drug
I.V.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag | Experimental | Open label, oral Avatrombopag 20 mg tablets taken daily during the first week. Dose tapering period commencing from week 28 for up to 8 weeks. Receives: Drug: Avatrombopag; Drug: Rituximab (Arm B) |
| Rituximab | Active comparator | Open label, intravenous infusions of 1000mg Rituximab 2 weeks apart Receives: Drug: Avatrombopag; Drug: Rituximab (Arm B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the oral TPO-RA, Avatrombopag, to Rituximab
To compare the efficacy of the oral TPO-RA, Avatrombopag to Rituximab by measuring the rates of durable responses defined as achieving platelet counts ≥ 50 X109/L in ≥3 of the bi-weekly measurements between weeks 20 and 28 including the last count without having received any other platelet elevating agents after randomization apart from rescue therapy received before end of week 10.
Measured: Assessed at week 28
Secondary outcomes (3)
The changes in the disease specific HRQoL
The changes in the disease specific HRQoL from baseline to weeks 28 and 78 measured by ITP-PAQ (Overall Quality of Life Scale) score.
Measured: Baseline to weeks 28 and weeks 78
Changes in the level of fatigue
The changes in the level of fatigue from baseline to weeks 28 and 78 measured by FACIT-Fatigue score
Measured: Baseline to weeks 28 and weeks 78
Rates of Sustained Response Off-Treatment (SROT)
The rates of Sustained Response Off-Treatment (SROT) at 78 weeks where the occurrence of SROT defined as
- A platelet count > 50 X109/L in at least 3 of the 4 planned visits between weeks 36 and 78 including week 78
- No administration of platelet elevating agent between weeks 36 and 78.
Measured: At 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus, Sykehuset i Vestfold HF, St. Olavs Hospital, Helse Stavanger HF, Sorlandet Hospital HF, University Hospital of North Norway, Haukeland University Hospital, Helse Nord-Trøndelag HF, Helse Fonna, Nordlandssykehuset HF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051915
- Sponsor's protocol ID
- RGCH006
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Two Second-Line Therapeutic Approaches for Immune Thrombocytopenia (ITP) - a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07051915
- Acronym / sponsor ID
- RGCH006
- Conditions
- Thrombocytopenia Purpura
- Keywords
- Avatrombopag, Rituximab, Thrombocytopenia, Immune thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus, Sykehuset i Vestfold HF, St. Olavs Hospital, Helse Stavanger HF, Sorlandet Hospital HF, University Hospital of North Norway, Haukeland University Hospital, Helse Nord-Trøndelag HF, Helse Fonna, Nordlandssykehuset HF
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- First phase extends from randomization to week 28
- Second phase extends from week 28 to 78
- Third phase extends from week 78 to the end of the trial (i.e. the last patient completing week 78)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag | Experimental | Drug: Avatrombopag, Drug: Rituximab (Arm B)Open label, oral Avatrombopag 20 mg tablets taken daily during the first week. Dose tapering period commencing from week 28 for up to 8 weeks. |
| Rituximab | Active comparator | Drug: Avatrombopag, Drug: Rituximab (Arm B)Open label, intravenous infusions of 1000mg Rituximab 2 weeks apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
- Concomitant autoimmune hemolytic anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvatrombopagDaily tablets | Drug | Avatrombopag, Rituximab |
| Rituximab (Arm B)I.V. | Drug | Avatrombopag, Rituximab |
Primary outcome
Efficacy of the oral TPO-RA, Avatrombopag, to Rituximab
Time frame: Assessed at week 28
To compare the efficacy of the oral TPO-RA, Avatrombopag to Rituximab by measuring the rates of durable responses defined as achieving platelet counts ≥ 50 X109/L in ≥3 of the bi-weekly measurements between weeks 20 and 28 including the last count without having received any other platelet elevating agents after randomization apart from rescue therapy received before end of week 10.
3 secondary outcomes
The changes in the disease specific HRQoL
Time frame: Baseline to weeks 28 and weeks 78
Changes in the level of fatigue
Time frame: Baseline to weeks 28 and weeks 78
Rates of Sustained Response Off-Treatment (SROT)
Time frame: At 78 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Avatrombopag and Rituximab (Arm B) in people with Thrombocytopenia Purpura, run by Ostfold Hospital Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the oral TPO-RA, Avatrombopag, to Rituximab (time frame: Assessed at week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.