Primary Immune Thrombocytopenia (ITP)Phase 3NCT07233213
An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia
A Phase 3 study testing Human immunoglobulin (pH4) for intravenous injection in people with Primary Immune Thrombocytopenia (ITP), run by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. at 9 sites in Turkey (Türkiye).
Trial summary
It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- Human immunoglobulin (pH4) for intravenous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 9 sitesTurkey (Türkiye)
- Study dates
- 24 Nov 2025to Dec 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;
- Patients with clinically confirmed chronic ITP (i.e., the course of disease > 12 months from diagnosis to signing the informed consent form);
- Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2 weeks before the first dose, and did not plan to increase the dosage of glucocorticoids or add other platelet-elevating drugs within 4 weeks after the first dose;
- Platelet count < 30 × 109/L;
- Patients who understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict accordance with the clinical study protocol.
Who cannot join
- Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and/or blood products, as well as excipients of the investigational drug, including those with a history of steroid hormone allergy;
- BMI ≥ 30 kg/m2;
- Secondary thrombocytopenia;
- Patients with the following clinical manifestations or disease history at screening:
- Hemoglobin <90 g/L or combined with immune hemolytic anemia;
- Chronic or recurrent neutropenia (defined as absolute neutrophil count < 1.5 × 109/L);
Show all 28Show fewer
- Patients with abnormal liver function: defined as ALT and/or AST > 3 times of the upper limit of normal; and/or total bilirubin ≥ 1.5 times of the upper limit of normal;
- Patients with related diseases of renal impairment, or serum creatinine ≥ 1.5 times the upper limit of normal value or creatinine clearance < 60 mL/min; ⑤. Patients with dysglycemia, including: Confirmed diagnosis of type 1/2 diabetes mellitus with HbA1c ≥7.0%, Fasting glucose ≥7.0 mmol/L (126 mg/dL), or Random glucose ≥11.1 mmol/L (200 mg/dL);
- ⑥. Blood diseases with coagulation factor defects;
- ⑦. Selective IgA deficiency patients with anti-IgA antibodies;
- ⑧. Patients with uncontrollable hypertension (SBP>160 mmHg or DBP>100 mmHg) or hypotension (SBP<90 mmHg or DBP<60 mmHg);
- ⑨. Patients with hyperviscosity, severe cardiovascular and cerebrovascular diseases (such as TIA, stroke, thrombotic disease, congestive heart failure of NYHA classification III/IV, arrhythmia requiring drug therapy (unstable angina pectoris) or myocardial infarction, etc.) and other serious systemic diseases before signing the informed consent form, who are not suitable for enrollment as judged by the investigator;
- ⑩. Suffering from mental illness, obvious mental disorder or epilepsy; incapacitated or cognitively impaired;
- Patients who failed to respond to previous treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin;
- Patients who had received treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin within 4 weeks prior to the first dose, or any other treatment with blood, blood products or blood derivatives within 4 weeks before signing the informed consent form;
- Patients who have received recombinant human thrombopoietin or eltrombopag and other receptor agonists within 2 weeks prior to the first dose (except for those who are ineffective after stable treatment > 2 weeks), or other drugs with clear indications of increasing platelet count;
- Patients who have received immunosuppressive or other immunomodulatory drugs within 3 weeks prior to the first dose (except for the following cases: glucocorticoids with stable dose and no dose change for > 2 weeks, and patients who failed to respond to stable treatment with azathioprine, cyclophosphamide or danazol for > 12 weeks);
- Patients who received rituximab within 8 weeks prior to the first dose;
- Patients who have been vaccinated with live attenuated vaccines within 8 weeks prior to the first dose or are planned to be vaccinated during the trial treatment, such as poliomyelitis vaccine, measles vaccine, rubella vaccine, mumps vaccine and varicella virus vaccine; patients who are planned to be vaccinated with measles vaccine within 1 year after the administration of the investigational drug;
- Patients scheduled for surgery during the trial and requiring transfusion of blood or blood products;
- Those who planned to continue taking non-steroidal anti-inflammatory drugs, warfarin and other drugs that affect platelet aggregation or coagulation function due to medical history during the trial;
- Patients who tested positive for any of HBs antigen (or nucleic acid test), HCV antibody (or nucleic acid test), Treponema pallidum antibody and HIV antibody (or nucleic acid test) at screening;
- Acute bacterial or acute viral infections that still require antibiotic treatment after enrollment;
- Pregnant and lactating women who have aborted for less than 30 days before signing the informed consent form (currently breastfeeding or currently not artificially breastfeeding but less than one year after delivery); female patients or spouses of male patients who plan to get pregnant or donate eggs or male patients who donate sperm during the trial and within 90 days after the last dose, and effective contraception cannot be guaranteed;
- Patients with a history of drug abuse or drug addiction;
- Patients who have participated (already included) in clinical trials of other drugs or medical devices within 3 months before signing the informed consent form;
- The survival time is expected to be less than 3 months, or the patients with other concomitant diseases are severely ill and may be dying during the treatment period and follow-up period. In the investigator's opinion, the efficacy cannot be evaluated or it is unlikely to complete the expected course of treatment and follow-up;
- Patients with poor compliance or who are not suitable to participate in this trial for other reasons as judged by the investigator.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Turkey (Türkiye)9 sites, 9 recruiting
- Recruiting
Adana City Education and Research Hospital, Hematology Department
Adana, Yüreğir, 01230
Assoc. Prof. Dr. Didar Yanardağ Açık, +90 532 157 76 56, didaryanardag@gmail.com
Assoc. Prof. Dr. Didar Yanardağ Açık
- Recruiting
Hacettepe University Faculty of Medicine
Ankara, Altındağ, 06230
Prof. Dr. Salih Aksu, +90 532 666 37 22, saksu@hacettepe.edu.tr
Prof. Dr. Salih Aksu
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara, Yenimahalle, 06200
Prof. Dr. Mehmet Sinan Dal, +90 532 524 56 94, Dr.sinandal@gmail.com
Prof. Dr. Mehmet Sinan Dal
- Recruiting
Antalya Training and Research Hospital
Antalya, Muratpaşa, 07100
Assoc. Prof. Dr. Volkan Karakuş, +90 505 765 67 78, dr_v_karakus@yahoo.com
Assoc. Prof. Dr. Volkan Karakuş
- Recruiting
Gaziantep University Şahinbey Training and Research Hospital
Gaziantep, Şehitkamil, 27310
Prof. Dr. Vahap Okan, +90 505 501 22 82, vahapokan@yahoo.com
Prof. Dr. Vahap Okan
- Recruiting
İstanbul University, Istanbul Faculty of Medicine
Istanbul, Fatih, 34093
Prof. Dr. Sevgi Beşışık, +90 532 394 47 16, sevgikalayoglu@yahoo.com
Prof. Dr. Sevgi Beşışık
- Recruiting
Erciyes University Hematology Hospital
Kayseri, Melikgazi, 38039
Neslihan Mandaci Sanli, +90 5057007392, ortoforia@hotmail.com
Neslihan Mandaci Sanli
- Recruiting
İnönü University Turgut Ozal Medical Center Training and Research Hospital
Malatya, Battalgazi, 44280
Prof. Dr. Emin Kaya, +90 532 413 64 47, emin.kaya@inonu.edu.tr
Prof. Dr. Emin Kaya
- Recruiting
VM Medical Park Mersin
Mersin, Mezitli, 33200
Prof. Dr. Anıl Tombak, +90 532 346 07 67, aniltombak@hotmail.com
Prof. Dr. Anıl Tombak
About this study
Official title: An Open-label, Single-arm, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Human Immunoglobulin for Intravenous Injection (5%) in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG). This clinical study is conducted to evaluate the efficacy and safety of 5% IVIG in patients with primary Immune Thrombocytopenia (ITP).
The study includes 4 periods and 9 visits (designated as V):
Read more
- Screening period (V1: 14 days before the first administration, preliminary examination);
- Baseline Period (V2: within 24 h before the first dose, Day 0);
- Treatment Period (V3: Day 1 to Day 5, administration of the drug in a hospital setting);
- Follow-up Period (V4-V9: visits to Study Site on Day 6, Day 7, Day 14 + 2, Day 21 + 3, Day 28 + 4, and Day 90 (+ 14) after the first dose).
In this study, the investigational product 5% IVIG will be administered at a dose of 0.4 g/kg/day (direct intravenous drip) for 5 consecutive days. The total duration of your participation in the study will be approximately 104 days. The investigational product will only be provided during the study period. It will not be supplied after the study ends.
The study will be conducted at clinical centers in Turkey. It is planned to obtain data from 36 patients included in the study (no more than 48 screened patients).
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Being tested
- Human immunoglobulin (pH4) for intravenous injection
- Keywords
- autoimmune hemorrhagic disease, hemorrhage
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human immunoglobulin (pH4) for intravenous injectionDrug
Administration: Direct intravenous drip at the initial rate of 1.0 ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, it can be gradually increased. The fastest drip rate should not exceed 3.0 ml/min (about 60 drops/min).
Direct intravenous drip, 0.4 g/kg daily for 5 consecutive days. The body weight value is kept as an integer (rounded off), and the dose calculated by body weight is within the allowable range of the theoretical dose ± 5 ml. For example, if the body weight of a patient is 57 kg and the theoretical dosage is 22.8 g/day based on 0.4 g/kg per day of human immunoglobulin for intravenous injection (5%, 5g/100ml strength), 456 ml of drug will be required, so the actual dose ranging from 451 ml to 461 ml is allowable.
| Study group | Role | What they receive |
|---|---|---|
| Patients who meet all of the following criteria are eligible to be included in this clinical trial. | Experimental | Investigational Product Name: Human immunoglobulin (pH4) for intravenous injection Formulation: Injection Specification: 5 g/vial (5%, 100 mL) Manufacturer: Grand Shuyang Life Sciences (Chengdu) Co., Ltd. Administration: Direct intravenous drip at the initial rate of 1.0 ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, it can be gradually increased. The fastest drip rate should not exceed 3.0 ml/min (about 60 drops/min).
Dosage: Direct intravenous drip, 0.4 g/kg daily for 5 consecutive days. The body weight value is kept as an integer (rounded off), and the dose calculated by body weight is within the allowable range of the theoretical dose ± 5 ml. For example, if the body weight of a patient is 57 kg and the theoretical dosage is 22.8 g/day based on 0.4 g/kg per day of human immunoglobulin for intravenous injection (5%, 5g/100ml strength), 456 ml of drug will be required, so the actual dose ranging from 451 ml to 461 ml is allowable. Receives: Drug: Human immunoglobulin (pH4) for intravenous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved platelet response within 7 days of the first transfusion
The response rate is defined as the proportion of patients whose platelet count > 30 × 109/L and increased to more than 2 times of baseline within 7 days after the first IVIg transfusion and absence of bleeding.
Measured: Within 7 days of the first transfusion
Secondary outcomes (7)
Time to and duration (days) of platelet count > 30 × 109/L
Time to and duration (days) of platelet count > 30 × 109/L and increased to more than 2-fold baseline within 7 days after the first IVIg infusion without bleeding
Measured: Within 7 days after the first IVIg infusion
Peak and time to peak platelet count
Peak and time to peak platelet count after the first infusion of IVIg (days)
Measured: After the first infusion of IVIg
Number and percentage of patients achieving complete response (CR), response (R), non-response (NR) and relapse
Number and percentage of patients achieving complete response (CR), response (R), non-response (NR) and relapse within 28 days after the first infusion
Measured: Within 28 days after the first infusion
Time to arrival of CR or R response and duration of response
Time to arrival of CR or R response and duration of response within 28 days after the first infusion
Measured: Within 28 days after the first infusion
Effective rate
Effective rate on the 14th, 21st and 28th day after the first dose
Measured: On the 14th, 21st and 28th day after the first dose
ITP bleeding scale score of patients
ITP bleeding scale score of patients within 7 days after the first infusion, and on Days 14, 21 and 28
Measured: Within 7 days after the first infusion, and on Days 14, 21 and 28
ITP bleeding scale score
ITP bleeding scale score on Day 7 after the first dose of treatment for all bleeding events during follow-up
Measured: On Day 7 after the first dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start24 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenia (ITP)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, open-label, multicenter phase III clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Shuyang Life Sciences (Chengdu) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233213
- Sponsor's protocol ID
- GLS-IVIG-A01-III
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Human Immunoglobulin for Intravenous Injection (5%) in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT07233213
- Acronym / sponsor ID
- GLS-IVIG-A01-III
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Keywords
- autoimmune hemorrhagic disease, hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Grand Shuyang Life Sciences (Chengdu) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 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.
It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG). This clinical study is conducted to evaluate the efficacy and safety of 5% IVIG in patients with primary Immune Thrombocytopenia (ITP).
The study includes 4 periods and 9 visits (designated as V):
- Screening period (V1: 14 days before the first administration, preliminary examination);
- Baseline Period (V2: within 24 h before the first dose, Day 0);
- Treatment Period (V3: Day 1 to Day 5, administration of the drug in a hospital setting);
- Follow-up Period (V4-V9: visits to Study Site on Day 6, Day 7, Day 14 + 2, Day 21 + 3, Day 28 + 4, and Day 90 (+ 14) after the first dose).
In this study, the investigational product 5% IVIG will be administered at a dose of 0.4 g/kg/day (direct intravenous drip) for 5 consecutive days. The total duration of your participation in the study will be approximately 104 days. The investigational product will only be provided during the study period. It will not be supplied after the study ends.
The study will be conducted at clinical centers in Turkey. It is planned to obtain data from 36 patients included in the study (no more than 48 screened patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, open-label, multicenter phase III clinical trial
| Arm | Type | Receives |
|---|---|---|
| Patients who meet all of the following criteria are eligible to be included in this clinical trial. | Experimental | Drug: Human immunoglobulin (pH4) for intravenous injectionInvestigational Product Name: Human immunoglobulin (pH4) for intravenous injection Formulation: Injection Specification: 5 g/vial (5%, 100 mL) Manufacturer: Grand Shuyang Life Sciences (Chengdu) Co., Ltd. Administration: Direct intravenous drip at the initial rate of 1.0 ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, it can be gradually increased. The fastest drip rate should not exceed 3.0 ml/min (about 60 drops/min). Dosage: Direct intravenous drip, 0.4 g/kg daily for 5 consecutive days. The body weight value is kept as an integer (rounded off), and the dose calculated by body weight is within the allowable range of the theoretical dose ± 5 ml. For example, if the body weight of a patient is 57 kg and the theoretical dosage is 22.8 g/day based on 0.4 g/kg per day of human immunoglobulin for intravenous injection (5%, 5g/100ml strength), 456 ml of drug will be required, so the actual dose ranging from 451 ml to 461 ml is allowable. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;
- Patients with clinically confirmed chronic ITP (i.e., the course of disease > 12 months from diagnosis to signing the informed consent form);
- Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2 weeks before the first dose, and did not plan to increase the dosage of glucocorticoids or add other platelet-elevating drugs within 4 weeks after the first dose;
- Platelet count < 30 × 109/L;
- Patients who understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict accordance with the clinical study protocol.
Key exclusion criteria (28 listed)
- Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and/or blood products, as well as excipients of the investigational drug, including those with a history of steroid hormone allergy;
- BMI ≥ 30 kg/m2;
- Secondary thrombocytopenia;
- Patients with the following clinical manifestations or disease history at screening:
- ⑥. Blood diseases with coagulation factor defects;
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 |
|---|---|---|
| Human immunoglobulin (pH4) for intravenous injectionAdministration: Direct intravenous drip at the initial rate of 1.0 ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, it can be gradually increased. The fastest drip rate should not exceed 3.0 ml/min (about 60 drops/min). Direct intravenous drip, 0.4 g/kg daily for 5 consecutive days. The body weight value is kept as an integer (rounded off), and the dose calculated by body weight is within the allowable range of the theoretical dose ± 5 ml. For example, if the body weight of a patient is 57 kg and the theoretical dosage is 22.8 g/day based on 0.4 g/kg per day of human immunoglobulin for intravenous injection (5%, 5g/100ml strength), 456 ml of drug will be required, so the actual dose ranging from 451 ml to 461 ml is allowable. | Drug | Patients who meet all of the following criteria are eligible to be included in this clinical trial. |
Primary outcome
Improved platelet response within 7 days of the first transfusion
Time frame: Within 7 days of the first transfusion
The response rate is defined as the proportion of patients whose platelet count > 30 × 109/L and increased to more than 2 times of baseline within 7 days after the first IVIg transfusion and absence of bleeding.
7 secondary outcomes
Time to and duration (days) of platelet count > 30 × 109/L
Time frame: Within 7 days after the first IVIg infusion
Peak and time to peak platelet count
Time frame: After the first infusion of IVIg
Number and percentage of patients achieving complete response (CR), response (R), non-response (NR) and relapse
Time frame: Within 28 days after the first infusion
Time to arrival of CR or R response and duration of response
Time frame: Within 28 days after the first infusion
Effective rate
Time frame: On the 14th, 21st and 28th day after the first dose
ITP bleeding scale score of patients
Time frame: Within 7 days after the first infusion, and on Days 14, 21 and 28
ITP bleeding scale score
Time frame: On Day 7 after the first dose of treatment
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 8 Apr 2026.
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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.
Hacettepe University Faculty of Medicine
Ankara, Turkey (Türkiye)
İnönü University Turgut Ozal Medical Center Training and Research Hospital
Malatya, Turkey (Türkiye)
İstanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human immunoglobulin (pH4) for intravenous injection in people with Primary Immune Thrombocytopenia (ITP), run by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. at 9 sites in Turkey (Türkiye).
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 5 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye). 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved platelet response within 7 days of the first transfusion (time frame: Within 7 days of the first transfusion). 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 8 Apr 2026.