Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)Phase 2PROTECTNCT07647029
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
A Phase 2 study testing Continuous Hetrombopag for 2 Cycles and Cyclic 14-day Hetrombopag for 2 Cycles in people with Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT), run by Fudan University.
Trial summary
This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
- What is being tested?
- Continuous Hetrombopag for 2 Cycles and Cyclic 14-day Hetrombopag for 2 Cycles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2026to 31 Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients with histopathologically confirmed breast cancer;
- Receiving or expected to receive chemotherapy-based antitumor therapy with a cycle length of ≥21 days, and anticipated to receive ≥2 cycles of therapy;
- ECOG performance status 0-2;
- Platelet count meeting one of the following criteria:
- Nadir platelet count < 50×10⁹/L in the previous antitumor treatment cycle;
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- Nadir platelet count ≥ 50×10⁹/L but < 75×10⁹/L in the previous antitumor treatment cycle, accompanied by high risk factors for bleeding*;
- Platelet count ≥ 100×10⁹/L at enrollment;
- Patients with breast cancer plus other malignancies are allowed, provided that the treatment plan is primarily for breast cancer;
- Adequate organ function:
- Bone marrow: ANC ≥ 1.5×10⁹/L; hemoglobin ≥ 8 g/dL;
- Hepatic and renal function: total bilirubin ≤ 1.5 × ULN; ALT, AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastasis); serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault formula);
- Coagulation: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN;
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, not be breastfeeding, and agree to use effective contraception during the study and for 7 days after the last dose of study drug.
- Male subjects with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 7 days after the last dose of study drug; sperm donation is prohibited during the study;
- Life expectancy ≥ 3 months;
- Voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to comply with follow-up procedures.
- High risk factors for bleeding History of bleeding; prior treatment with platinum agents, gemcitabine, cytarabine, anthracyclines, PARP inhibitors (e.g., niraparib), etc.; combination of targeted agents and chemotherapeutic agents known to increase the risk of thrombocytopenia; history of radiotherapy or ongoing radiotherapy, especially to long bones and flat bones (e.g., pelvis, sternum).
Who cannot join
- Presence of hematological disorders, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
- Uncontrolled active infection;
- History of arterial or venous thrombosis;
- Patients with bleeding tendency, or evidence of inherited bleeding diathesis or coagulation disorders;
- Pregnant or breastfeeding women, or female patients of childbearing potential not using effective contraception;
- Participation in another clinical trial of thrombopoietic agents within 4 weeks prior to enrollment;
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- Presence of uncontrolled neurological or psychiatric disorders, poor compliance, or inability to cooperate and report treatment-related reactions;
- Bone marrow involvement;
- Administration of rhTPO or rhIL-11 within 7 days prior to enrollment;
- Hypersensitivity to the study drug(s).
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
This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT.
Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (>2 cycles vs. ≤2 cycles).
Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.
- Being tested
- Continuous Hetrombopag for 2 Cycles, Cyclic 14-day Hetrombopag for 2 Cycles
- Keywords
- Breast cancer, Secondary prophylaxis, Hetrombopag, Thrombocytopenia
- Medical subject headings
- Breast Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Hetrombopag for 2 CyclesDrug
Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle
Cyclic 14-day Hetrombopag for 2 CyclesDrug
Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| No prophylactic use of hetrombopag | No intervention | No prophylactic use of hetrombopag |
| Continuous Hetrombopag for 2 Cycles | Experimental | Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Receives: Drug: Continuous Hetrombopag for 2 Cycles |
| Cyclic 14-day Hetrombopag for 2 Cycles | Experimental | Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle Receives: Drug: Cyclic 14-day Hetrombopag for 2 Cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Measured: At the end of Cycle 2 (each cycle ≥21 days)
Secondary outcomes (6)
Duration of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Measured: At the end of Cycle 2 (each cycle ≥21 days)
Incidence and duration of grade ≥3 thrombocytopenia (PLT < 50×10⁹/L)
Measured: At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients who successfully completed two chemotherapy cycles without thrombocytopenia-related modifications to subsequent antineoplastic therapy
Measured: At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients without rescue therapy for thrombocytopenia (e.g., platelet transfusion, interleukin-11, recombinant human thrombopoietin)
Measured: At the end of Cycle 2 (each cycle ≥21 days)
Nadir and peak platelet counts
Measured: At the end of Cycle 2 (each cycle ≥21 days)
Incidence of adverse events
Measured: From enrollment to 21 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start28 May 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647029
- Sponsor's protocol ID
- 2603340-13
- Acronym
- PROTECT
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024.
PubMed 38882443Kuter DJ. Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies. Haematologica. 2022 Jun 1;107(6):1243-1263. doi: 10.3324/haematol.2021.279512.
PubMed 35642485Jin G, Wu Y, She Z, Ma X, Deng S, Wang W, Wu Y, Li Q. Prophylactic Administration of Recombinant Human Thrombopoietin in the Secondary Prevention of Thrombocytopenia Induced by XELOX Adjuvant Chemotherapy in Patients With Stage III Colorectal Cancer. Am J Ther. 2021 Apr 7;28(4):e513-e516. doi: 10.1097/MJT.0000000000001331. No abstract available.
PubMed 33852489Li Q, Jin G, Jiang C, Zhang Z, Hou J, Zhao J, Chen F, Li Z. Prophylactic administration of recombinant human thrombopoietin attenuates XELOX or SOX regimen-induced thrombocytopaenia. Arch Med Sci. 2021 Aug 9;17(5):1440-1446. doi: 10.5114/aoms/141134. eCollection 2021. No abstract available.
PubMed 34522277Xu Y, Song X, Du F, Zhao Q, Liu L, Ma Z, Lu S. A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer. J Cancer. 2018 Nov 25;9(24):4718-4725. doi: 10.7150/jca.26690. eCollection 2018.
PubMed 30588257Chen M, Li L, Xia Q, Chen X, Liao Z, Wang C, Shen B, Zhou M, Zhang Q, Zhang Y, Qian L, Yuan X, Wang Z, Xue C, An X, Liu B, Gu K, Hou M, Wang X, Wang W, Li E, Zhong J, Cheng J, Shu Y, Yang N, Wang H, Yang R, Liu T, Deng T, Ma F, Liao W, Qiu W, Chen Y, Chen X, Zhang M, Xu R, Li X, Feng J, Ba Y, Shi Y. A real-world observation on thrombopoietic agents for patients with cancer treatment-induced thrombocytopenia in China: A multicenter, cross-sectional study. Cancer. 2024 Apr 15;130(S8):1524-1538. doi: 10.1002/cncr.35292. Epub 2024 Mar 22.
PubMed 38515388Bashour FN, Teran JC, Mullen KD. Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease. Am J Gastroenterol. 2000 Oct;95(10):2936-9. doi: 10.1111/j.1572-0241.2000.02325.x.
PubMed 11051371
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
- ClinicalTrials.gov ID
- NCT07647029
- Acronym / sponsor ID
- PROTECT / 2603340-13
- Keywords
- Breast cancer, Secondary prophylaxis, Hetrombopag, Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 May 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Jun 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.
This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT.
Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (>2 cycles vs. ≤2 cycles).
Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No prophylactic use of hetrombopag | No intervention | –No prophylactic use of hetrombopag |
| Continuous Hetrombopag for 2 Cycles | Experimental | Drug: Continuous Hetrombopag for 2 CyclesHetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle |
| Cyclic 14-day Hetrombopag for 2 Cycles | Experimental | Drug: Cyclic 14-day Hetrombopag for 2 CyclesHetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years;
- Patients with histopathologically confirmed breast cancer;
- Receiving or expected to receive chemotherapy-based antitumor therapy with a cycle length of ≥21 days, and anticipated to receive ≥2 cycles of therapy;
- ECOG performance status 0-2;
- Platelet count meeting one of the following criteria:
Key exclusion criteria (10 listed)
- Presence of hematological disorders, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
- Uncontrolled active infection;
- History of arterial or venous thrombosis;
- Patients with bleeding tendency, or evidence of inherited bleeding diathesis or coagulation disorders;
- Pregnant or breastfeeding women, or female patients of childbearing potential not using effective contraception;
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 |
|---|---|---|
| Continuous Hetrombopag for 2 CyclesHetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle | Drug | Continuous Hetrombopag for 2 Cycles |
| Cyclic 14-day Hetrombopag for 2 CyclesHetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle | Drug | Cyclic 14-day Hetrombopag for 2 Cycles |
Primary outcome
Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
6 secondary outcomes
Duration of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Incidence and duration of grade ≥3 thrombocytopenia (PLT < 50×10⁹/L)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients who successfully completed two chemotherapy cycles without thrombocytopenia-related modifications to subsequent antineoplastic therapy
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients without rescue therapy for thrombocytopenia (e.g., platelet transfusion, interleukin-11, recombinant human thrombopoietin)
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Nadir and peak platelet counts
Time frame: At the end of Cycle 2 (each cycle ≥21 days)
Incidence of adverse events
Time frame: From enrollment to 21 days after the last dose of study drug
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 15 Jun 2026.
- Background: PubMed 38882443Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024.
- Background: PubMed 35642485Kuter DJ. Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies. Haematologica. 2022 Jun 1;107(6):1243-1263. doi: 10.3324/haematol.2021.279512.
- Background: PubMed 33852489Jin G, Wu Y, She Z, Ma X, Deng S, Wang W, Wu Y, Li Q. Prophylactic Administration of Recombinant Human Thrombopoietin in the Secondary Prevention of Thrombocytopenia Induced by XELOX Adjuvant Chemotherapy in Patients With Stage III Colorectal Cancer. Am J Ther. 2021 Apr 7;28(4):e513-e516. doi: 10.1097/MJT.0000000000001331. No abstract available.
- Background: PubMed 34522277Li Q, Jin G, Jiang C, Zhang Z, Hou J, Zhao J, Chen F, Li Z. Prophylactic administration of recombinant human thrombopoietin attenuates XELOX or SOX regimen-induced thrombocytopaenia. Arch Med Sci. 2021 Aug 9;17(5):1440-1446. doi: 10.5114/aoms/141134. eCollection 2021. No abstract available.
- Background: PubMed 30588257Xu Y, Song X, Du F, Zhao Q, Liu L, Ma Z, Lu S. A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer. J Cancer. 2018 Nov 25;9(24):4718-4725. doi: 10.7150/jca.26690. eCollection 2018.
- Background: PubMed 38515388Chen M, Li L, Xia Q, Chen X, Liao Z, Wang C, Shen B, Zhou M, Zhang Q, Zhang Y, Qian L, Yuan X, Wang Z, Xue C, An X, Liu B, Gu K, Hou M, Wang X, Wang W, Li E, Zhong J, Cheng J, Shu Y, Yang N, Wang H, Yang R, Liu T, Deng T, Ma F, Liao W, Qiu W, Chen Y, Chen X, Zhang M, Xu R, Li X, Feng J, Ba Y, Shi Y. A real-world observation on thrombopoietic agents for patients with cancer treatment-induced thrombocytopenia in China: A multicenter, cross-sectional study. Cancer. 2024 Apr 15;130(S8):1524-1538. doi: 10.1002/cncr.35292. Epub 2024 Mar 22.
- Background: PubMed 11051371Bashour FN, Teran JC, Mullen KD. Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease. Am J Gastroenterol. 2000 Oct;95(10):2936-9. doi: 10.1111/j.1572-0241.2000.02325.x.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Continuous Hetrombopag for 2 Cycles and Cyclic 14-day Hetrombopag for 2 Cycles in people with Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT), run by Fudan University.
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 18 inclusion and 10 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Jian Zhang (+8618017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L) (time frame: At the end of Cycle 2 (each cycle ≥21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07647029, which also lists 7 linked publications.
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 15 Jun 2026.