Idiopathic Thrombocytopenic PurpuraPhase 2NCT06287567
Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)
A Phase 2 study testing Lusutrombopag Oral Tablet in people with Idiopathic Thrombocytopenic Purpura and Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia
- What is being tested?
- Lusutrombopag Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 6 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Males and females ≥18 years of age
- Subjects>60 years must have had a diagnostic bone marrow aspiration in the last 3 years or responded to treatment (platelet count ≥50 x 10^9/L)
- Participants diagnosed with primary persistent/chronic ITP (greater than or equal to 3 months duration) and an average of two platelet count less than 30 x 10^9/L. Conditions which may cause thrombocytopenia other than ITP should be ruled out, including but not limited to systemic lupus erythematosus (SLE)，aplastic anemia (AA), and myelodysplastic syndromes (MDS)
- Relapsed persistent or chronic ITP status, with or without prior splenectomy. Participants who previously received one or more ITP therapies
- Subjects receiving rescue therapy (including but not limited to corticosteroids, immunoglobulins and immunosuppressant) must have completed these therapies for at least 1 week or failed within 1 week prior to dosing on the first day (Visit 1)
- Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed, but must be receiving a dose that has been stable for at least 4 weeks prior to dosing on the first day (Visit 1)
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- Subjects receiving Chinese herbal medicine must be stopped 1 weeks prior to dosing on the first day (Visit 1), and Chinese herbal medicine is not allowed during the study
- Subjects receiving steroid therapy must be on a stable dose for at least 2 weeks prior to screening (same milligram amount ± 10%； and ≤20 mg of equivalent dose of prednisone)
- Two consecutive mean platelet count < 30×10^9/(a single platelet count of< 35×10^9/L is allowed） during screening if subjects were not receiving steroids, or two consecutive mean platelet count < 50×10^9/ if they were receiving steroids. Two Platelet counts must be measured at an interval of greater than 2 days and less than 14 days，and the second platelet count must be measured within 96 hours of day1（Visit 1）
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) within 20% of the upper limit of normal (ULN) at Screening or PT did not exceed normal value by ±3s and APTT by ±10s. No other history of coagulation state except ITP.
- A complete blood count within the reference range ，including count of white blood cell (WBC) differential not indicative of a disorder other than ITP, with the following exceptions: a) Hemoglobin: participants with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal (LLN) are eligible for inclusion; participants with anemia(hemoglobin levels <10g/dl ) clearly attributable to ITP (excessive blood loss) are also eligible for inclusion; b) Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L (elevated WBC/ANC due to corticosteroid treatment is acceptable).
- All subjects must agree to take progestin or barrier contraception: patients with potential fertility (excluding hysterectomy, bilateral salpingectomy, bilateral tubal ligation or postmenopausal women for more than one year; Men with bilateral vasectomy) must take effective contraceptive measures at least 2 weeks before taking the study drug for the first time, throughout the study and within 28 days after the end of the study (or early termination of the study); Women with potential fertility must have a negative pregnancy test during the screening period and on the 0th day of the trial.
- A signed and dated written consent obtained prior to the performance of Screening procedures
Who cannot join
- History of inherited or acquired, clinically important hemorrhagic clotting disorder
- Females who were pregnant or lactating, or receiving other hormone/chemical contraceptives
- Patients with potential fertility refused to take contraceptive methods
- Laboratory abnormalities
- Hemoglobin <10.0 g/dL for men or women, not clearly related to ITP
- Absolute neutrophil count < 1000/mm3
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- Abnormal peripheral blood smear with evidence of fibrosis confirmed by bone marrow biopsy
- Total bilirubin > 1.5 x ULN
- Alanine aminotransferase (ALT) > 1.5 x ULN
- Aspartate aminotransferase (AST) > 1.5 x ULN
- Creatinine > 1.5 x ULN
- Human immunodeficiency virus positive
- Hepatitis A Immunoglobulin M（IgM) antibody positive, hepatitis B surface antigen positive and HBV DNA ≥1000IU/ml or hepatitis C antibody positive，with a history of acute hepatitis, cirrhosis, portal hypertension or chronic active hepatitis.
- Thyroid stimulating hormone (TSH) > 1.5 x ULN; or
- Free thyroxine (T4) > 1.5 x ULN
- Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g. romiplostim, recombinant human thrombopoietin (rhTPO), avatrombopag, eltrombopag and herombopag) within 4 weeks prior to initial screening.In addition, participants are allowed to be enrolled at the discretion of the investigator when platelet counts are below 30 x 10^9/L within the 4 weeks after withdrawal of thrombopoietin (TPO) mimetics/agonists
- Subjects unresponsive to previous TPO mimetics/agonists
- Exposure to an investigative medication within 4 weeks prior to the initial Screening Visit or Use of the following drugs or treatment prior to Visit 1 (Day 1):
- Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy
- Within 12weeks - rituximab
- History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Initial screening
- Splenectomy within 4 weeks prior to Initial Screening
- Other abnormalities except ITP or situations that investigators deem inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Lusutrombopag in Chinese Adults With Persistent or Chronic Immune Thrombocytopenia
This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy
Read the detailed description
This is an open-label, single-arm study of lusutrombopag initiated at a dose of 3mg daily titrated to a maximum dose of 6mg daily in the treatment of Chinese adults with persistent or chronic Immune thrombocytopenia (ITP) with or without prior splenectomy after failing first line therapy such corticosteroids and IV immunoglobulin. The study consists of three phases: Screening, Core Study（participants are treated with lusutrombopag 3mg daily for up to 4 weeks), and Titration study (participants are treated with lusutrombopag titrated to a maximum dose of 6mg daily according to their platelet counts）
- Being tested
- Lusutrombopag Oral Tablet
- Keywords
- Lusutrombopag, Immune thrombocytopenia, Thrombopoietin receptor agonists
- 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.
Lusutrombopag Oral TabletDrug
Also called MULPLETA®, S-888711
Participants receive lusutrombopag 3 mg administered orally once a day for up to 4 weeks and doses are adjusted based on platelet counts during week 5-12. If a subject's platelet count remains < 50x10^9 /L, the dose could have been increased up to a maximum dose of 6 mg（2 tablets).If a subject's platelet count reaches ≥ 250x10^9 /L during the first 4 weeks, treatment is stopped and participants are allowed to enter into Titration Study in advance when platelet count drops to ≥100x10^9 /L.
| Study group | Role | What they receive |
|---|---|---|
| Lusutrombopag | Experimental | Participants receive lusutrombopag 3 mg administered orally once a day for up to 4 weeks and titrated to a maximum dose of 6 mg during week 5 and week12 based on the platelet count (PLT) Receives: Drug: Lusutrombopag Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Platelet Response after 4 Weeks
Platelet responses to lusutrombopag was evaluated using the platelet count defined as ≥50x10^9 /L on study drug treatment after 4 weeks of dosing（on Day 29) or prematurely ≥250x10^9 /L prior to Day 29.
Measured: on Day 29 of Treatment
Secondary outcomes (17)
Percentage of Participants with a Platelet Response after 12 Weeks (Day 85)
Platelet responses to lusutrombopag was evaluated using the platelet count defined as ≥50x10^9 /L on study drug treatment after 12 weeks of dosing（on Day 85).
Measured: on Day 85 of treatment
Percentage of Participants Who Achieved a Platelet Count of ≥50×10^9/L After 6 Weeks of Dosing
Platelet responses to lusutrombopag was evaluated using the platelet count defined as ≥50x10^9 /L after week 6
Measured: on Day 43 of treatment
Percentage of Participants Who at least once Achieved a Platelet Count of ≥50x10^9/L in Week 1 ,2,3,4 in the Core Study
Platelet responses to lusutrombopag was evaluated using the platelet count defined as ≥50x10^9 /L from baseline to Week 4.
Measured: Baseline, Week 4
Change in Platelet Count
Change from baseline in platelet count was assessed at every visit from Baseline to Week 12
Measured: Baseline, 12 Weeks
Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment
Platelet responses to lusutrombopag was evaluated using the platelet count defined as ≥50x10^9 /L. Participants who at least once achieved a platelet count of ≥50x10^9 /L during the Core Study and Titration Study respectively were assessed.
Measured: Baseline, up to 12 Weeks
Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment
Platelet's complete responses to lusutrombopag was evaluated using the platelet count defined as a platelet count ≥100x10^9 /L. Participants who at least once achieved a platelet count of ≥100x10^9 /L during the Core Study and Titration Study respectively were assessed.
Measured: Baseline, up to 12 Weeks
Time to first Achieve a Platelet Count of ≥ 50x10^9/L
The time to first achieve a response was defined as the Day when participants first reached a platelet count of ≥ 50×10^9/L from baseline.
Measured: Baseline, up to 12 Weeks
Time to first Achieve a Platelet Count of ≥100x10^9 /L
Defined as the Day when participants first reached a platelet count of ≥ 100×10^9/L from baseline.
Measured: Baseline, up to 12 Weeks
Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively.
The percentage of partial response were defined as a platelet count of ≥30×10^9/L, a≥2-fold increase from baseline
Measured: Baseline, up to 12 Weeks
Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate
Durable platelet response rate was defined as platelet count ≥50×10^9/L in ≥75% of assessments(weeks)
Measured: Baseline, up to 12 Weeks
Cumulated Number of Weeks of Response（≥50x10^9/L）
Cumulative number of weeks of platelet response was defined as the total number of weeks in which platelet count is ≥50x10^9/L during the Core Study and Titration Study
Measured: Baseline, up to 12 Weeks
Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline
Lusutrombopag dose titration and downward titration of concomitant ITP medications was allowed at Week ,when Titration Study begins.
Measured: Day 29，Week 12
The Incidence and Rating of Bleeding Events During the Study
Bleeding assessments were performed by the Investigator according to the World Health Organization (WHO) criteria bleeding scale:
Grade 0: no bleeding; Grade 1: petechial bleeding; Grade 2: mild blood loss (clinically significant); Grade 3: gross blood loss, requires transfusion (severe); Grade 4: debilitating blood loss, retinal or cerebral associated with fatality.
Measured: Baseline，Week12
Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study
Participants who received rescue therapy for bleeding events during the study. steroids, intravenous immunoglobulin and platelet transfusion were considered as rescue therapy for bleeding events.
Measured: Baseline , Week16
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product during the course of a clinical investigation, including any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not thought to be related to the IP. AEs reported after initial study drug administration were considered treatment-emergent.
A serious adverse event is defined as any AE that resulted in death, was life-threatening, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or an important medical event that, based upon medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.
A treatment-related AE is any AE determined by the investigator to be possibly related, probably related, or definitely related to study drug.
Measured: Baseline through Week 12 while receiving treatment and at Week 16 after discontinuation of treatment.
Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16
The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F) assesses the severity of patient's fatigue. The Full version of FACIT-F contains 40 items. Total score is computed by summing 5 subscales: ranging from 0-160.This study assessed the subscale Fatigue (range 0-52), which contains 13 items, The higher the score, the milder the patients' fatigue.
Measured: Baseline，Week16
Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16
The Immune Thrombocytopenic Purpura (ITP)-Patient Assessment Questionnaire (ITP-PAG) assesses the overall quality of life (Qol) of patients. Possible scores range from 0 to 100. Higher total score indicates better QoL
Measured: Baseline，Week16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start17 Apr 2024
- Primary completion13 Nov 2024
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Lei, MD, Principal investigator, Chinese Academy of Medical Science and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287567
- Sponsor's protocol ID
- IIT2023078
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Lusutrombopag in Chinese Adults With Persistent or Chronic Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06287567
- Acronym / sponsor ID
- IIT2023078
- Keywords
- Lusutrombopag, Immune thrombocytopenia, Thrombopoietin receptor agonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 1 Mar 2024 (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 exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy
Detailed description
This is an open-label, single-arm study of lusutrombopag initiated at a dose of 3mg daily titrated to a maximum dose of 6mg daily in the treatment of Chinese adults with persistent or chronic Immune thrombocytopenia (ITP) with or without prior splenectomy after failing first line therapy such corticosteroids and IV immunoglobulin. The study consists of three phases: Screening, Core Study（participants are treated with lusutrombopag 3mg daily for up to 4 weeks), and Titration study (participants are treated with lusutrombopag titrated to a maximum dose of 6mg daily according to their platelet counts）
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lusutrombopag | Experimental | Drug: Lusutrombopag Oral TabletParticipants receive lusutrombopag 3 mg administered orally once a day for up to 4 weeks and titrated to a maximum dose of 6 mg during week 5 and week12 based on the platelet count (PLT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females ≥18 years of age
- Subjects>60 years must have had a diagnostic bone marrow aspiration in the last 3 years or responded to treatment (platelet count ≥50 x 10^9/L)
- Participants diagnosed with primary persistent/chronic ITP (greater than or equal to 3 months duration) and an average of two platelet count less than 30 x 10^9/L. Conditions which may cause thrombocytopenia other than ITP should be ruled out, including but not limited to systemic lupus erythematosus (SLE)，aplastic anemia (AA), and myelodysplastic syndromes (MDS)
- Relapsed persistent or chronic ITP status, with or without prior splenectomy. Participants who previously received one or more ITP therapies
- Subjects receiving rescue therapy (including but not limited to corticosteroids, immunoglobulins and immunosuppressant) must have completed these therapies for at least 1 week or failed within 1 week prior to dosing on the first day (Visit 1)
Key exclusion criteria (23 listed)
- History of inherited or acquired, clinically important hemorrhagic clotting disorder
- Females who were pregnant or lactating, or receiving other hormone/chemical contraceptives
- Patients with potential fertility refused to take contraceptive methods
- Laboratory abnormalities
- Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g. romiplostim, recombinant human thrombopoietin (rhTPO), avatrombopag, eltrombopag and herombopag) within 4 weeks prior to initial screening.In addition, participants are allowed to be enrolled at the discretion of the investigator when platelet counts are below 30 x 10^9/L within the 4 weeks after withdrawal of thrombopoietin (TPO) mimetics/agonists
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 |
|---|---|---|
| Lusutrombopag Oral TabletAlso: MULPLETA®, S-888711Participants receive lusutrombopag 3 mg administered orally once a day for up to 4 weeks and doses are adjusted based on platelet counts during week 5-12. If a subject's platelet count remains < 50x10^9 /L, the dose could have been increased up to a maximum dose of 6 mg（2 tablets).If a subject's platelet count reaches ≥ 250x10^9 /L during the first 4 weeks, treatment is stopped and participants are allowed to enter into Titration Study in advance when platelet count drops to ≥100x10^9 /L. | Drug | Lusutrombopag |
Primary outcome
Percentage of Participants with a Platelet Response after 4 Weeks
Time frame: on Day 29 of Treatment
Platelet responses to lusutrombopag was evaluated using the platelet count defined as ≥50x10^9 /L on study drug treatment after 4 weeks of dosing（on Day 29) or prematurely ≥250x10^9 /L prior to Day 29.
17 secondary outcomes
Percentage of Participants with a Platelet Response after 12 Weeks (Day 85)
Time frame: on Day 85 of treatment
Percentage of Participants Who Achieved a Platelet Count of ≥50×10^9/L After 6 Weeks of Dosing
Time frame: on Day 43 of treatment
Percentage of Participants Who at least once Achieved a Platelet Count of ≥50x10^9/L in Week 1 ,2,3,4 in the Core Study
Time frame: Baseline, Week 4
Change in Platelet Count
Time frame: Baseline, 12 Weeks
Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment
Time frame: Baseline, up to 12 Weeks
Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment
Time frame: Baseline, up to 12 Weeks
Time to first Achieve a Platelet Count of ≥ 50x10^9/L
Time frame: Baseline, up to 12 Weeks
Time to first Achieve a Platelet Count of ≥100x10^9 /L
Time frame: Baseline, up to 12 Weeks
Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively.
Time frame: Baseline, up to 12 Weeks
Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate
Time frame: Baseline, up to 12 Weeks
Cumulated Number of Weeks of Response（≥50x10^9/L）
Time frame: Baseline, up to 12 Weeks
Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline
Time frame: Day 29，Week 12
The Incidence and Rating of Bleeding Events During the Study
Time frame: Baseline，Week12
Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study
Time frame: Baseline , Week16
Number of Participants With Adverse Events (AEs)
Time frame: Baseline through Week 12 while receiving treatment and at Week 16 after discontinuation of treatment.
Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16
Time frame: Baseline，Week16
Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16
Time frame: Baseline，Week16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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. This study is not recruiting at the moment.
Zhang Lei, MD principal investigator
Chinese Academy of Medical Science and Blood Disease Hospital
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 Lusutrombopag Oral Tablet in people with Idiopathic Thrombocytopenic Purpura and 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 13 inclusion and 23 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants with a Platelet Response after 4 Weeks (time frame: on Day 29 of Treatment). 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 19 Dec 2025.