Immune ThrombocytopeniaPhase 2NCT07687134
Eltrombopag Plus Telitacicept vs. Eltrombopag Alone for Steroid-refractory/Relapsed ITP
A Phase 2 study testing Eltrombopag in people with Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Background: Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. Corticosteroids are first-line therapy, but about one-third of patients relapse or are refractory. Eltrombopag (a TPO-RA) promotes platelet production, yet some patients show no response or relapse upon discontinuation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 31 Dec 2027
- Phase
- Phase 2
- 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
- Age ≥18 years, regardless of sex.
- Clinically diagnosed with immune thrombocytopenia for at least 3 months prior to enrollment. Platelet count <30×10⁹/L within 48 hours before the first dose of study drug.
- Previous failure (ineffective, unable to maintain response, or relapse) to first-line standard corticosteroid therapy for ITP as recommended by guidelines.
- Any prior emergency treatment for ITP (e.g., corticosteroids, platelet transfusion, intravenous immunoglobulin) must have been completed at least 2 weeks before the first dose.
- Patients receiving maintenance corticosteroid therapy must be on a stable dose for at least 2 weeks prior to the first dose; patients receiving immunosuppressants (e.g., azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc.) must be on a stable dose for at least 4 weeks prior to the first dose; anti-CD20 antibody therapy must have been completed >3 months prior.
- Understand the study procedures and voluntarily provide written informed consent.
Who cannot join
- Received anti-CD20 antibody therapy within 3 months.
- Uncontrolled primary disease of vital organs, such as malignant tumors, liver failure, heart failure, renal failure, etc.
- Positive for HIV.
- Uncontrolled active viral or bacterial infections, including positive for hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus, or syphilis.
- Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.
- Currently have cardiac disease requiring treatment, arrhythmia, or hypertension poorly controlled as judged by the investigator.
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- Patients with thrombotic diseases such as pulmonary embolism, thrombosis, atherosclerosis, etc.
- Patients with mental disorders who are unable to give informed consent or undergo study procedures and follow-up normally.
- Patients whose toxic symptoms from prior treatment before enrollment have not yet resolved.
- Other serious diseases that may limit the patient's participation in this study (e.g., poorly controlled diabetes; severe cardiac insufficiency; myocardial infarction, unstable arrhythmia, or unstable angina within the past 6 months; gastric ulcer; active autoimmune disease, etc.).
- Pregnant women, suspected pregnancy (positive urinary human chorionic gonadotropin pregnancy test at screening), or lactating patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
shuo chen, Master, 02223608030, chenshuo@ihcams.ac.cn
About this study
Official title: Eltrombopag Combined With Telitacicept Versus Eltrombopag Monotherapy for the Treatment of Immune Thrombocytopenia Refractory or Relapsed to Corticosteroid Therapy: A Randomized Exploratory, Controlled, Open-label, Phase II Clinical Study
Background: Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. Corticosteroids are first-line therapy, but about one-third of patients relapse or are refractory. Eltrombopag (a TPO-RA) promotes platelet production, yet some patients show no response or relapse upon discontinuation. Telitacicept, a TACI-Fc fusion protein, dual-targets BAFF and APRIL, inhibiting B cell and plasma cell function and reducing autoantibody production, potentially providing synergistic immunomodulatory benefit.
Objective: To evaluate the sustained response rate of eltrombopag plus telitacicept vs. eltrombopag alone in patients with steroid-refractory/relapsed ITP.
Read more
Design: Randomized, open-label, controlled, exploratory Phase II study. 40 patients planned (20 combination, 20 monotherapy). Combination group: eltrombopag + telitacicept . Monotherapy group: eltrombopag alone for 12 weeks. Monotherapy patients with no response after 4 weeks may cross over to the combination group. After 12 weeks, treatment is stopped and patients are followed until Week 24.
Primary endpoint: Proportion of patients maintaining platelet count ≥30×10⁹/L with no bleeding at 24 weeks post-treatment. Secondary endpoints include platelet response rates during 12 weeks, safety, bleeding events, etc.
Expected results: The combination group is expected to have a significantly higher proportion of patients achieving the primary endpoint without increased adverse events.
Population: Age ≥18, diagnosed ITP ≥3 months, baseline platelets <30×10⁹/L, prior corticosteroid failure.
Safety: Monitoring for bleeding, infection, thrombosis, cytopenia, etc., with dose adjustment/cessation as per protocol.
Conclusion: This study explores whether dual-targeting (platelet production + autoimmune suppression) with eltrombopag and telitacicept can provide more durable remission for steroid-refractory/relapsed ITP patients.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Eltrombopag
- 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.
EltrombopagDrug
Also called Eltrombopagplus telitacicept
eltrombopag plus telitacicept vs. eltrombopag alone
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy group | Active comparator | Not described Receives: Drug: Eltrombopag |
| Combination group | Experimental | Not described Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Response Comparison
To compare the sustained response rate of eltrombopag combined with telitacicept versus eltrombopag monotherapy in patients with immune thrombocytopenia who are refractory or relapsed to prior corticosteroid therapy.
Measured: Within 24weeks of first dose
Secondary outcomes (9)
Platelet Response Within 12 Weeks
Percentage of subjects achieving at least one platelet count ≥30×10⁹/L with an increase of ≥2-fold from baseline within 12 weeks of first dose, without receiving rescue therapy.
Measured: Within 12 weeks of first dose
Platelet ≥50×10⁹/L at Week 12
Proportion of patients with platelet count ≥50×10⁹/L at Week 12 of treatment.
Measured: Within 12 weeks of first dose
Platelet ≥100×10⁹/L at Week 12
Proportion of patients with platelet count ≥100×10⁹/L at Week 12 of treatment.
Measured: Within 12 weeks of first dose
Time to First Platelet Response
Time to first platelet count ≥30×10⁹/L with an increase of ≥2-fold from baseline.
Measured: Within 12 weeks of first dose
Proportion of Days with Platelet ≥30×10⁹/L
Proportion of days with platelet count ≥30×10⁹/L within the 12-week period.
Measured: Within 12 weeks of first dose
Platelet Response After Crossover (Monotherapy Group)
Percentage of subjects in the monotherapy group achieving platelet count ≥30×10⁹/L with an increase of ≥2-fold from baseline within 12 weeks after crossover.
Measured: With in 24 weeks of first dose
Safety and Tolerability
Safety and tolerability endpoints: incidence and severity of adverse events and serious adverse events
Measured: Within 24 weeks of first dose
Time to Rescue Therapy or Platelet Decline
Time from treatment discontinuation to first need for rescue therapy or platelet count <30×10⁹/L.
Measured: Within 24 weeks of first dose
Proportion Requiring Rescue Therapy
Proportion of patients requiring rescue therapy during the follow-up period.
Measured: Within 24 weeks of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687134
- Sponsor's protocol ID
- TACI-ITP-2026
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eltrombopag Combined With Telitacicept Versus Eltrombopag Monotherapy for the Treatment of Immune Thrombocytopenia Refractory or Relapsed to Corticosteroid Therapy: A Randomized Exploratory, Controlled, Open-label, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07687134
- Acronym / sponsor ID
- TACI-ITP-2026
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
Background: Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. Corticosteroids are first-line therapy, but about one-third of patients relapse or are refractory. Eltrombopag (a TPO-RA) promotes platelet production, yet some patients show no response or relapse upon discontinuation. Telitacicept, a TACI-Fc fusion protein, dual-targets BAFF and APRIL, inhibiting B cell and plasma cell function and reducing autoantibody production, potentially providing synergistic immunomodulatory benefit.
Objective: To evaluate the sustained response rate of eltrombopag plus telitacicept vs. eltrombopag alone in patients with steroid-refractory/relapsed ITP.
Design: Randomized, open-label, controlled, exploratory Phase II study. 40 patients planned (20 combination, 20 monotherapy). Combination group: eltrombopag + telitacicept . Monotherapy group: eltrombopag alone for 12 weeks. Monotherapy patients with no response after 4 weeks may cross over to the combination group. After 12 weeks, treatment is stopped and patients are followed until Week 24.
Primary endpoint: Proportion of patients maintaining platelet count ≥30×10⁹/L with no bleeding at 24 weeks post-treatment. Secondary endpoints include platelet response rates during 12 weeks, safety, bleeding events, etc.
Expected results: The combination group is expected to have a significantly higher proportion of patients achieving the primary endpoint without increased adverse events.
Population: Age ≥18, diagnosed ITP ≥3 months, baseline platelets <30×10⁹/L, prior corticosteroid failure.
Safety: Monitoring for bleeding, infection, thrombosis, cytopenia, etc., with dose adjustment/cessation as per protocol.
Conclusion: This study explores whether dual-targeting (platelet production + autoimmune suppression) with eltrombopag and telitacicept can provide more durable remission for steroid-refractory/relapsed ITP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy group | Active comparator | Drug: Eltrombopag |
| Combination group | Experimental | Drug: Eltrombopag |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years, regardless of sex.
- Clinically diagnosed with immune thrombocytopenia for at least 3 months prior to enrollment. Platelet count <30×10⁹/L within 48 hours before the first dose of study drug.
- Previous failure (ineffective, unable to maintain response, or relapse) to first-line standard corticosteroid therapy for ITP as recommended by guidelines.
- Any prior emergency treatment for ITP (e.g., corticosteroids, platelet transfusion, intravenous immunoglobulin) must have been completed at least 2 weeks before the first dose.
- Patients receiving maintenance corticosteroid therapy must be on a stable dose for at least 2 weeks prior to the first dose; patients receiving immunosuppressants (e.g., azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc.) must be on a stable dose for at least 4 weeks prior to the first dose; anti-CD20 antibody therapy must have been completed >3 months prior.
Key exclusion criteria (11 listed)
- Received anti-CD20 antibody therapy within 3 months.
- Uncontrolled primary disease of vital organs, such as malignant tumors, liver failure, heart failure, renal failure, etc.
- Positive for HIV.
- Uncontrolled active viral or bacterial infections, including positive for hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus, or syphilis.
- Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.
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 |
|---|---|---|
| EltrombopagAlso: Eltrombopagplus telitacicepteltrombopag plus telitacicept vs. eltrombopag alone | Drug | Combination group, Monotherapy group |
Primary outcome
Sustained Response Comparison
Time frame: Within 24weeks of first dose
To compare the sustained response rate of eltrombopag combined with telitacicept versus eltrombopag monotherapy in patients with immune thrombocytopenia who are refractory or relapsed to prior corticosteroid therapy.
9 secondary outcomes
Platelet Response Within 12 Weeks
Time frame: Within 12 weeks of first dose
Platelet ≥50×10⁹/L at Week 12
Time frame: Within 12 weeks of first dose
Platelet ≥100×10⁹/L at Week 12
Time frame: Within 12 weeks of first dose
Time to First Platelet Response
Time frame: Within 12 weeks of first dose
Proportion of Days with Platelet ≥30×10⁹/L
Time frame: Within 12 weeks of first dose
Platelet Response After Crossover (Monotherapy Group)
Time frame: With in 24 weeks of first dose
Safety and Tolerability
Time frame: Within 24 weeks of first dose
Time to Rescue Therapy or Platelet Decline
Time frame: Within 24 weeks of first dose
Proportion Requiring Rescue Therapy
Time frame: Within 24 weeks of first dose
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 7 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag in people with Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact shuo chen (02223608030, chenshuo@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Response Comparison (time frame: Within 24weeks of first dose). 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 7 Jul 2026.