ITP - Immune ThrombocytopeniaRPE-ITPNCT06790888
Ripertamab Plus Eltrombopag vs. Eltrombopag in ITP Patients Post-Steroid Failure
A study testing Ripertamab/Eltrombopag and Eltrombopag in people with ITP - Immune Thrombocytopenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This study aims to evaluate the efficacy and safety of Ripertamab in combination with Eltrombopag compared to Eltrombopag alone for patients with Primary Immune Thrombocytopenia (ITP) who have not responded to or have relapsed after first-line steroid therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ITP - Immune Thrombocytopenia
- What is being tested?
- Ripertamab/Eltrombopag and Eltrombopag
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Dec 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Confirmed Primary Immune Thrombocytopenia (ITP) with an age range of 18 to 80 years, inclusive, and no gender restrictions.
- Bone Marrow Cytology: Diagnosis via bone marrow cytology excluding secondary thrombocytopenia caused by other diseases, with primary ITP patients who are unresponsive to or have relapsed after first-line steroid therapy (platelet count drops below 30×10^9/L).
- Coagulation Status: Laboratory tests show prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) not exceeding 20% above the upper limit of normal values, with no history of coagulation disorders other than ITP.
- Bone Marrow Function: Normal bone marrow function indicated by an absolute neutrophil count (ANC) ≥1.5×10^9/L and hemoglobin (Hb) ≥90 g/L.
- Liver and Kidney Function: Normal liver and kidney function with serum direct bilirubin and indirect bilirubin ≤1.5 times the upper limit of normal (ULN); 5.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); serum creatinine ≤1.5 times the upper limit of normal (ULN).
- 6.Psychiatric History: No history of psychiatric disorders. 7.Informed Consent: Voluntary signing of an informed consent form.
Who cannot join
- Life-Threatening Bleeding: Presence of bleeding that poses an immediate threat to life, such as severe anemia or central nervous system bleeding.
- Recent Treatment: Use of intravenous immunoglobulin, thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), immunosuppressants, anti-CD20 monoclonal antibodies, or systemic corticosteroids within 28 days prior to enrollment.
- Malignancy History: History of malignancy.
- Cardiac Conditions: Presence of severe heart failure or other diseases significantly impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, arrhythmias, or prolonged QTc interval within the last 3 months).
- Coagulation Disorders: History of coagulation disorders other than ITP, such as disseminated intravascular coagulation (DIC), hemolytic uremic syndrome (HUS), or thrombotic thrombocytopenic purpura (TTPP).
- Viral Markers: Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test ≥10^4 copies/mL; or Hepatitis B virus (HBV) markers positive for HBsAg and/or HBcAb with HBV DNA positivity.
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- Immunocompromised: History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, autoimmune diseases, or a history of organ transplantation.
- Tuberculosis: Suspected active or latent tuberculosis.
- Active Infections: Presence of active infections at enrollment, or any significant infectious events within 4 weeks prior to enrollment or major surgery within 4 weeks.
- Pregnancy and Lactation: Pregnant or nursing women, or women of childbearing potential or considering pregnancy during the study period.
- Other Conditions: Any other conditions deemed by the investigator as contraindications for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized Controlled, Open-Label Study of Ripertamab Combined With Eltrombopag Versus Eltrombopag for ITP Patients After First-Line Steroid Therapy
This study aims to evaluate the efficacy and safety of Ripertamab in combination with Eltrombopag compared to Eltrombopag alone for patients with Primary Immune Thrombocytopenia (ITP) who have not responded to or have relapsed after first-line steroid therapy. Participants will be randomly assigned to one of two treatment groups and followed for 52 weeks to assess response rates and safety.
Read the detailed description
This is a multicenter, open-label, randomized controlled clinical trial designed to compare the effects of Ripertamab plus Eltrombopag versus Eltrombopag monotherapy in adults with ITP. The study will enroll approximately 78 participants, aged 18 to 80 years, who have had an inadequate response to or relapsed after first-line steroid therapy. The primary outcome measure is the sustained response rate at 12 weeks post-treatment initiation. Secondary outcomes include overall response rate, complete response rate, median time to response, median sustained response time, and safety. Participants will undergo regular blood tests and clinical assessments throughout the study period.
- Conditions
- ITP - Immune Thrombocytopenia
- Being tested
- Ripertamab/Eltrombopag, Eltrombopag
- Keywords
- Ripertamab
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripertamab/EltrombopagCombination product
Also called Anti-CD20/TPO-RA
Ripertamab, a novel anti-CD20 monoclonal antibody, in combination with Eltrombopag . Ripertamab is administered intravenously at a dose of 375 mg/m² BSA on Day 1 . If the participant remains in remission at the 3-month mark, an additional intravenous dose of 375 mg/m² Ripertamab is administered. Eltrombopag are given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28.
EltrombopagDrug
Also called TPO-RA
Eltrombopag as a single therapy. Eltrombopag is a thrombopoietin receptor agonist given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28.
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag/Ripertamab | Experimental | Eltrombopag (starting at 2.5mg once daily, 28 days, adjusted based on platelet count),Ripertamab (375 mg/m² BSA on Day 1)，If the participant remains in remission at the 3-month, an additional intravenous dose of 375 mg/m² BSA Ripertamab is administered Receives: Combination Product: Ripertamab/Eltrombopag |
| Eltrombopag | Active comparator | Eltrombopag (starting at 2.5mg once daily, 28 days, adjusted based on platelet count) Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Response Rate at 12 Weeks
The primary outcome measure is the proportion of patients who achieve a sustained response at 12 weeks after the initiation of treatment. A sustained response is defined as a platelet count of ≥30×10^9/L without bleeding and without the need for rescue therapy.
Measured: up to 12weeks
Secondary outcomes (6)
Overall Response Rate (ORR)
The percentage of patients who achieve any response (complete or partial) to the treatment as measured by an increase in platelet count from baseline.
Measured: through study completion, an average of 1 year
Complete Response Rate (CR%)
The proportion of patients who achieve a complete response, defined as a platelet count of ≥100×10^9/L without bleeding and without the need for rescue therapy.
Measured: through study completion, an average of 1 year
Median Time to Response (mTTR)
The time at which 50% of the patients achieve a response, measured from the start of treatment until the first evidence of therapeutic effect.
Measured: 1 year
Median Sustained Response Time (mSRT)
The time at which 50% of the patients maintain a response without relapse, measured from the start of treatment until the response is no longer sustained.
Measured: 1 year
24-week Sustained Response Rate (24-week SR)
The proportion of patients who maintain a sustained response at 24 weeks post-treatment initiation, defined by a platelet count of ≥100×10^9/L without bleeding and without rescue therapy.
Measured: up to 24 weeks
52-week Sustained Response Rate (52-week SR)
The percentage of patients who continue to show a sustained response at 52 weeks after starting treatment, with platelet counts meeting predefined criteria.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITP - Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sinocelltech Ltd.
- Responsible party
- Sponsor
- Investigators
- Heng MEI, Ph.D&M.D, Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790888
- Sponsor's protocol ID
- UHCT240527
- Acronym
- RPE-ITP
- Status last verified
- Nov 2024
- First submitted
- 15 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled, Open-Label Study of Ripertamab Combined With Eltrombopag Versus Eltrombopag for ITP Patients After First-Line Steroid Therapy
- ClinicalTrials.gov ID
- NCT06790888
- Acronym / sponsor ID
- RPE-ITP / UHCT240527
- Conditions
- ITP - Immune Thrombocytopenia
- Keywords
- Ripertamab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sinocelltech Ltd.
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jan 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 aims to evaluate the efficacy and safety of Ripertamab in combination with Eltrombopag compared to Eltrombopag alone for patients with Primary Immune Thrombocytopenia (ITP) who have not responded to or have relapsed after first-line steroid therapy. Participants will be randomly assigned to one of two treatment groups and followed for 52 weeks to assess response rates and safety.
Detailed description
This is a multicenter, open-label, randomized controlled clinical trial designed to compare the effects of Ripertamab plus Eltrombopag versus Eltrombopag monotherapy in adults with ITP. The study will enroll approximately 78 participants, aged 18 to 80 years, who have had an inadequate response to or relapsed after first-line steroid therapy. The primary outcome measure is the sustained response rate at 12 weeks post-treatment initiation. Secondary outcomes include overall response rate, complete response rate, median time to response, median sustained response time, and safety. Participants will undergo regular blood tests and clinical assessments throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag/Ripertamab | Experimental | Combination Product: Ripertamab/EltrombopagEltrombopag (starting at 2.5mg once daily, 28 days, adjusted based on platelet count),Ripertamab (375 mg/m² BSA on Day 1)，If the participant remains in remission at the 3-month, an additional intravenous dose of 375 mg/m² BSA Ripertamab is administered |
| Eltrombopag | Active comparator | Drug: EltrombopagEltrombopag (starting at 2.5mg once daily, 28 days, adjusted based on platelet count) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis: Confirmed Primary Immune Thrombocytopenia (ITP) with an age range of 18 to 80 years, inclusive, and no gender restrictions.
- Bone Marrow Cytology: Diagnosis via bone marrow cytology excluding secondary thrombocytopenia caused by other diseases, with primary ITP patients who are unresponsive to or have relapsed after first-line steroid therapy (platelet count drops below 30×10^9/L).
- Coagulation Status: Laboratory tests show prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) not exceeding 20% above the upper limit of normal values, with no history of coagulation disorders other than ITP.
- Bone Marrow Function: Normal bone marrow function indicated by an absolute neutrophil count (ANC) ≥1.5×10^9/L and hemoglobin (Hb) ≥90 g/L.
- Liver and Kidney Function: Normal liver and kidney function with serum direct bilirubin and indirect bilirubin ≤1.5 times the upper limit of normal (ULN); 5.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); serum creatinine ≤1.5 times the upper limit of normal (ULN).
Key exclusion criteria (11 listed)
- Life-Threatening Bleeding: Presence of bleeding that poses an immediate threat to life, such as severe anemia or central nervous system bleeding.
- Recent Treatment: Use of intravenous immunoglobulin, thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), immunosuppressants, anti-CD20 monoclonal antibodies, or systemic corticosteroids within 28 days prior to enrollment.
- Malignancy History: History of malignancy.
- Cardiac Conditions: Presence of severe heart failure or other diseases significantly impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, arrhythmias, or prolonged QTc interval within the last 3 months).
- Coagulation Disorders: History of coagulation disorders other than ITP, such as disseminated intravascular coagulation (DIC), hemolytic uremic syndrome (HUS), or thrombotic thrombocytopenic purpura (TTPP).
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 |
|---|---|---|
| Ripertamab/EltrombopagAlso: Anti-CD20/TPO-RARipertamab, a novel anti-CD20 monoclonal antibody, in combination with Eltrombopag . Ripertamab is administered intravenously at a dose of 375 mg/m² BSA on Day 1 . If the participant remains in remission at the 3-month mark, an additional intravenous dose of 375 mg/m² Ripertamab is administered. Eltrombopag are given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28. | Combination product | Eltrombopag/Ripertamab |
| EltrombopagAlso: TPO-RAEltrombopag as a single therapy. Eltrombopag is a thrombopoietin receptor agonist given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28. | Drug | Eltrombopag |
Primary outcome
Sustained Response Rate at 12 Weeks
Time frame: up to 12weeks
The primary outcome measure is the proportion of patients who achieve a sustained response at 12 weeks after the initiation of treatment. A sustained response is defined as a platelet count of ≥30×10^9/L without bleeding and without the need for rescue therapy.
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: through study completion, an average of 1 year
Complete Response Rate (CR%)
Time frame: through study completion, an average of 1 year
Median Time to Response (mTTR)
Time frame: 1 year
Median Sustained Response Time (mSRT)
Time frame: 1 year
24-week Sustained Response Rate (24-week SR)
Time frame: up to 24 weeks
52-week Sustained Response Rate (52-week SR)
Time frame: up to 52 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 24 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Heng MEI, Ph.D&M.D study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Ripertamab/Eltrombopag and Eltrombopag in people with ITP - Immune Thrombocytopenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 6 inclusion and 11 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 24 Jan 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.
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?
Contact Heng Mei, Ph.D&M.D (027-8572600 ext. 027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Response Rate at 12 Weeks (time frame: up to 12weeks). 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 24 Jan 2025.