Immune Thrombocytopenia With Positive ANA AntibodiesNCT06479317
The Efficacy and Safety of HCQ Plus DEX in ANA Positive ITP
A study testing Hydroxychloroquine Oral Tablet and Dexamethasone oral in people with Immune Thrombocytopenia With Positive ANA Antibodies, run by Yunfeng Cheng at 7 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn if hydroxychloroquine (HCQ) plus dexamethasone (DEX) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus DEX. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Immune Thrombocytopenia With Positive ANA Antibodies
- What is being tested?
- Hydroxychloroquine Oral Tablet and Dexamethasone oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 24 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age is between 15-75 years old, and gender is unlimited.
- Before randomization, the clinical diagnosis is primary immune thrombocytopenia. The platelet count is less than 30×10^9 / L within 1 week before enrollment, or platelet count is less than 50×10^9 / L with bleeding symptoms within 1 week before enrollment.
- The antinuclear antibody is positive.
- Other autoantibodies (mainly including dsDNA antibodies, SSA, SSB, RNP, β 2-GP, ACA, ANCA) are negative.
- Prothrombin time does not exceed ± 3s of the normal value ranget, activated partial thrombin time is not outside normal range ± 10s; no history of coagulopathy except ITP.
- Understand the study procedures and sign the written informed consent form.
Who cannot join
- Secondary thrombocytopenia caused by myelodysplastic syndrome, immune diseases such as systemic lupus erythematosus, early aplastic anemia, atypical reanemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and various other causes.
- The participant has experienced any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history indicate thrombophilia.
- Congestive heart disease, including New York Heart Association (NHYA) Grade III / IV, occurred within 3 months prior to screening, arrhythmia requiring medication or myocardial infarction, or arrhythmia known to increase the risk of thrombotic events (such as atrial fibrillation), or corrected QT interval (QTc) is longer than 450 ms, or QTc> 480 ms in paricipants with bundle branch block.
- With severe hemorrhage (intracranial hemorrhage) or coagulation dysfunction (INR and APTT> 125% upper limit of normal).
- With poorly controlled hypertension and diabetes mellitus.
- With severe digestive tract diseases affecting drug absorption.
Show all 21Show fewer
- With serious mental illness patient.
- With liver cirrhosis or portal hypertension.
- With evidence of malignant tumor activity, or receiving anti-tumor treatment within 5 years prior to the screening.
- Addicted to alcohol or drugs.
- Having participated in other clinical trials within 3 months prior to screening.
- Having received any immunomodulatory medication for other diseases 3 months before screening.
- Having received any medication affecting platelet function ( Including but not limited to aspirin, aspirin-containing complexes, clopidogrel, salicylates, and / or non-steroidal anti-inflammatory drugs NSAIDs ) or anticoagulant therapy for over consecutive 3 days within 2 weeks before screening.
- With Glucose-6-phosphate dehydrogenase deficiency.
- With retinal or visual field changes caused by 4-aminoquinoline compounds.
- Being allergic to 4-aminoquinoline compounds.
- Having evidence of Human Immunodeficiency Virus (HIV)/ hepatitis C virus(HCV)/ hepatitis B virus(HBV) infection (HIV antibody or HCV antibody is positive, HBV surface antigen is positive, or HBV surface antigen is negative but HBV-DNA indicating viral replication.
- With a history of vaccination within 8 weeks before enrollment or scheduled for vaccination during the trial period.
- Moderate to severe anaemia (hemoglobin <90g / L).
- Glutamate transaminotransferase (ALT) or glutamate transaminase (AST) is higher than 1.5 times the upper limit of normal value (ULN), or total bilirubin or blood creatinine is higher than 1.2 times the ULN.
- Participants being pregnant or lactating, or with potential fertility, reluctance to use effective contraception within the entire trial cycle and within 28 days after the end of the trial (or within 28 days after premature withdraw).
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
China4 sites, 4 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Lili Ji, 086-021-64041990, ji.lili@zs-hospital.sh.cn
Yunfeng Cheng
- Recruiting
Zhongshan Wusong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200094
Hongjuan Lu, 13564618950, 13564618950@163.com
- Recruiting
Shanghai Jinshan Hospital
Shanghai, Shanghai Municipality, 201508
Yunfeng Cheng, 15921398238, yfcheng@fudan.edn.cn
- Recruiting
Zhongshan Qingpu Hospital, Fudan University
Shanghai, Shanghai Municipality, 201700
Fanli Hua, 18116017032, hua_fanli@fudan.edu.cn
Macau2 sites, 2 recruiting
- Recruiting
Dr. Stanley Ho Medical Foundation
Macao, 999078
Gregory Cheng, 852-60269018, gregorycheng@um.edu.mo
- Recruiting
University Hospital, Macau University of Science and Technology.
Macao, 999078
Gregory Cheng, 852-60269018, gregorycheng@um.edu.mo
Hong Kong1 site, 1 recruiting
- Recruiting
Health and Humanity Research Centre, Hongkong, China.
Hong Kong, 999077
Gregory Cheng, 852-60269018, gregorycheng@um.edu.mo
About this study
Official title: The Efficacy and Safety of Hydroxychloroquine Plus Dexamethasone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-labled Clinical Trial
The goal of this clinical trial is to learn if hydroxychloroquine (HCQ) plus dexamethasone (DEX) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus DEX. The main questions it aims to answer are:
Does HCQ plus DEX raise the response rate in participants, compared to DEX alone? Does HCQ plus DEX prolong the response duration in participants, compared to DEX alone? What medical problems do participants have when taking HCQ plus DEX? Researchers will compare HCQ plus DEX with DEX alone to see if HCQ plus DEX works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies.
Read more
Participants will:
Take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10^9/L after 2 weeks, take DEX every day for another consecutive 4 days) with or without HCQ twice a day for 1 year , Visit the clinic once every 1 weeks for the first 4 weeks, and once every 2-4 weeks in the following 11 months for checkups and tests, Keep a diary of their symptoms.
Read the detailed description
Primary immune thrombocytopenia (Primary immune thrombocytopenia, ITP) is an acquired autoimmune hemorrhagic disease characterized with decreased peripheral platelet count and increased risk of bleeding. It has been reported that 33.3% -39.2% of ITP patients have positive antinuclear antibodies (ANA) in the course of disease.In the meantime, they do not meet the diagnostic criteria for rheumatic diseases such as lupus erythematosus(SLE). ITP patients with positive ANA are prone to relapse and chronicity. Therefore, it is necessary to explore new clinical treatments to attain longer-term remission in these patients.
Hydroxychloroquine (HCQ) has immune modulating role on a variety of immune cells.A clinical trial enrolled immune thrombocytopenia secondary to SLE, and ITP with positive anti-nuclear antibodiy (ANA) were treated with HCQ combined with glucocorticoids. The results showed an overall response rate of 60% (24 / 40), including 18 continuous complete response (CR) and 6 continuous response (R), and some patients had continued elevated platelet counts 3 months after treatment initiation. The above studies illustrate that HCQ contributes to the treatment of chronic ITP, especially as a long-term therapeutic agent with low economic burden and well-tolerated. In conclusion, it can be seen that HCQ and dexamethasone have complementary mechanism of action and complementary time window, which can be used as a combination for the treatment of ITP select.
- Being tested
- Hydroxychloroquine Oral Tablet, Dexamethasone oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Oral TabletDrug
Also called Hydroxychloroquine
Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.
Dexamethasone oralDrug
Also called Dexamethasone
Dexamethasone is given at 40mg every morning after meals for 4 consecutive days( if platelet count does not recover higher than 30×10^9/L after 2 weeks, dexamethasone is given 40mg every day for another consecutive 4 days).
| Study group | Role | What they receive |
|---|---|---|
| HCQ plus DEX group | Experimental | This group is experiment group. Participants will take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10^9/L after 2 weeks, take DEX every day for another consecutive 4 days) with HCQ twice a day for 1 year Receives: Drug: Hydroxychloroquine Oral Tablet; Drug: Dexamethasone oral |
| DEX group | Placebo comparator | This group is control group.Participants will take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10^9/L after 2 weeks, take DEX every day for another consecutive 4 days) Receives: Drug: Dexamethasone oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The percentage of participants with platelet counts higher than 30×10^9/L and at least twice the baseline platelet count , for at least two consecutive tests (7 days apart).
Measured: 4 weeks
Secondary outcomes (8)
Complete response rate
The percentage of participants with platelet counts higher than 100×10^9/L , for at least two consecutive tests (7 days apart).
Measured: 1 year
Duration of response
Time from response to disease relapse (platelet count ≤ 30×10^9/L on any test or occurance of bleeding symptoms )
Measured: 1 year
Durable response rate
Percentage of patients with complete remission lasting at least 6 months without any additional ITP-specific therapy
Measured: 1 year
Platelet count at each visit
Average platelet count at each visit
Measured: 1 year
Time to response
Time from starting treatment to response
Measured: 4 weeks
Response rate throughout the trial
The percentage of response participants (platelet counts higher than 30×10^9/L and at least twice the baseline platelet count ) at each visit
Measured: 1 year
WHO bleeding score
WHO bleeding score at each visit
Measured: 1 year
Adverse reaction
Adverse reaction at each visit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start24 Apr 2024
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenia With Positive ANA AntibodiesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunfeng Cheng
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai Jinshan Hospital, Zhongshan Qingpu Hospital, Fudan University, Zhongshan Wusong Hospital, Fudan University, Macau University of Science and Technology Hospital, Health and Humanity Research Centre, Hongkong, Dr. Stanley Ho Medical Foundation, Macau
- Responsible party
- Sponsor-investigator, Yunfeng Cheng, Shanghai Zhongshan Hospital
- Investigators
- Yunfeng Cheng, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479317
- Sponsor's protocol ID
- ZSLCYJ202325
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966.
PubMed 31794604Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.
PubMed 24254965Mejdoub S, Hachicha H, Gargouri L, Feki S, Mahfoudh A, Masmoudi H. Antinuclear antibodies in children: clinical signification and diagnosis utility. Tunis Med. 2021 Octobre;99(10):980-984.
PubMed 35288899Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.
PubMed 28416506
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Hydroxychloroquine Plus Dexamethasone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-labled Clinical Trial
- ClinicalTrials.gov ID
- NCT06479317
- Acronym / sponsor ID
- ZSLCYJ202325
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Yunfeng ChengUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai Jinshan Hospital, Zhongshan Qingpu Hospital, Fudan University, Zhongshan Wusong Hospital, Fudan University, Macau University of Science and Technology Hospital, Health and Humanity Research Centre, Hongkong, Dr. Stanley Ho Medical Foundation, Macau
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jun 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.
The goal of this clinical trial is to learn if hydroxychloroquine (HCQ) plus dexamethasone (DEX) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus DEX. The main questions it aims to answer are:
Does HCQ plus DEX raise the response rate in participants, compared to DEX alone? Does HCQ plus DEX prolong the response duration in participants, compared to DEX alone? What medical problems do participants have when taking HCQ plus DEX? Researchers will compare HCQ plus DEX with DEX alone to see if HCQ plus DEX works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies.
Participants will:
Take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10^9/L after 2 weeks, take DEX every day for another consecutive 4 days) with or without HCQ twice a day for 1 year , Visit the clinic once every 1 weeks for the first 4 weeks, and once every 2-4 weeks in the following 11 months for checkups and tests, Keep a diary of their symptoms.
Detailed description
Primary immune thrombocytopenia (Primary immune thrombocytopenia, ITP) is an acquired autoimmune hemorrhagic disease characterized with decreased peripheral platelet count and increased risk of bleeding. It has been reported that 33.3% -39.2% of ITP patients have positive antinuclear antibodies (ANA) in the course of disease.In the meantime, they do not meet the diagnostic criteria for rheumatic diseases such as lupus erythematosus(SLE). ITP patients with positive ANA are prone to relapse and chronicity. Therefore, it is necessary to explore new clinical treatments to attain longer-term remission in these patients.
Hydroxychloroquine (HCQ) has immune modulating role on a variety of immune cells.A clinical trial enrolled immune thrombocytopenia secondary to SLE, and ITP with positive anti-nuclear antibodiy (ANA) were treated with HCQ combined with glucocorticoids. The results showed an overall response rate of 60% (24 / 40), including 18 continuous complete response (CR) and 6 continuous response (R), and some patients had continued elevated platelet counts 3 months after treatment initiation. The above studies illustrate that HCQ contributes to the treatment of chronic ITP, especially as a long-term therapeutic agent with low economic burden and well-tolerated. In conclusion, it can be seen that HCQ and dexamethasone have complementary mechanism of action and complementary time window, which can be used as a combination for the treatment of ITP select.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCQ plus DEX group | Experimental | Drug: Hydroxychloroquine Oral Tablet, Drug: Dexamethasone oralThis group is experiment group. Participants will take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10^9/L after 2 weeks, take DEX every day for another consecutive 4 days) with HCQ twice a day for 1 year |
| DEX group | Placebo comparator | Drug: Dexamethasone oralThis group is control group.Participants will take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10^9/L after 2 weeks, take DEX every day for another consecutive 4 days) |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age is between 15-75 years old, and gender is unlimited.
- Before randomization, the clinical diagnosis is primary immune thrombocytopenia. The platelet count is less than 30×10^9 / L within 1 week before enrollment, or platelet count is less than 50×10^9 / L with bleeding symptoms within 1 week before enrollment.
- The antinuclear antibody is positive.
- Other autoantibodies (mainly including dsDNA antibodies, SSA, SSB, RNP, β 2-GP, ACA, ANCA) are negative.
- Prothrombin time does not exceed ± 3s of the normal value ranget, activated partial thrombin time is not outside normal range ± 10s; no history of coagulopathy except ITP.
Key exclusion criteria (21 listed)
- Secondary thrombocytopenia caused by myelodysplastic syndrome, immune diseases such as systemic lupus erythematosus, early aplastic anemia, atypical reanemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and various other causes.
- The participant has experienced any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history indicate thrombophilia.
- Congestive heart disease, including New York Heart Association (NHYA) Grade III / IV, occurred within 3 months prior to screening, arrhythmia requiring medication or myocardial infarction, or arrhythmia known to increase the risk of thrombotic events (such as atrial fibrillation), or corrected QT interval (QTc) is longer than 450 ms, or QTc> 480 ms in paricipants with bundle branch block.
- With severe hemorrhage (intracranial hemorrhage) or coagulation dysfunction (INR and APTT> 125% upper limit of normal).
- With poorly controlled hypertension and diabetes mellitus.
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 |
|---|---|---|
| Hydroxychloroquine Oral TabletAlso: HydroxychloroquineHydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake. | Drug | HCQ plus DEX group |
| Dexamethasone oralAlso: DexamethasoneDexamethasone is given at 40mg every morning after meals for 4 consecutive days( if platelet count does not recover higher than 30×10^9/L after 2 weeks, dexamethasone is given 40mg every day for another consecutive 4 days). | Drug | DEX group, HCQ plus DEX group |
Primary outcome
Overall response rate
Time frame: 4 weeks
The percentage of participants with platelet counts higher than 30×10^9/L and at least twice the baseline platelet count , for at least two consecutive tests (7 days apart).
8 secondary outcomes
Complete response rate
Time frame: 1 year
Duration of response
Time frame: 1 year
Durable response rate
Time frame: 1 year
Platelet count at each visit
Time frame: 1 year
Time to response
Time frame: 4 weeks
Response rate throughout the trial
Time frame: 1 year
WHO bleeding score
Time frame: 1 year
Adverse reaction
Time frame: 1 year
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 28 Jun 2024.
- Background: PubMed 31794604Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966.
- Results publication: PubMed 24254965Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.
- Results publication: PubMed 35288899Mejdoub S, Hachicha H, Gargouri L, Feki S, Mahfoudh A, Masmoudi H. Antinuclear antibodies in children: clinical signification and diagnosis utility. Tunis Med. 2021 Octobre;99(10):980-984.
- Results publication: PubMed 28416506Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.
- Individual participant dataSharing planned: Yes
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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.
Yunfeng Cheng principal investigator
Shanghai Zhongshan Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine Oral Tablet and Dexamethasone oral in people with Immune Thrombocytopenia With Positive ANA Antibodies, run by Yunfeng Cheng at 7 sites in 3 countries.
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 21 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 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Macau, Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Ji (86-021-64041990, ji.lili@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 4 weeks). 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 NCT06479317, which also lists 4 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 28 Jun 2024.