Connective Tissue DiseasesPhase 2NCT05998759
Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
A Phase 2 study testing Telitacicept in people with Connective Tissue Diseases and Thrombocytopenia, run by Beijing Hospital at 23 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Connective Tissue Diseases, Thrombocytopenia
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 23 sitesChina
- Study dates
- 2 Dec 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have been diagnosed with connective tissue disease (CTD)-associated thrombocytopenia. And CTD includes primary Sjögren syndrome (according to the 2002 American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria), systemic lupus erythematosus (SLE, according to the 1997 or the 2009 ACR classification criteria), and undifferentiated connective tissue disease (according to the 1999 international classification criteria)
- Refractory thrombocytopenia defined as:
- Either: Failure to maintain sustained remission after treatment by glucocorticoid and at least one immunosuppressant (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate, leflunomide and hydroxychloroquine, et al.) Or: Relapse during oral glucocorticoid tapering or after withdrawal
- 50×10^9/L>PLT
- anti-nuclear antibody (ANA) positive (≥1:80, any karyotype) detected in the laboratory of each research center
- Standard therapy should be maintained stable for at least 14 days prior to the first dose of the experimental drug or placebo. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.)
- Signed informed consent form, willing or able to participate in all required study evaluations and procedures
Who cannot join
- Vital organ lethal bleeding (including but not limited to central nervous system bleeding, digestive tract bleeding) at screening, or intracranial bleeding 6 months prior to screening
- Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic syndrome, or thrombocytopenia secondary to other causes (such as sepsis, Epstein-Barr virus infection, cytomegalovirus infection, Corona Virus Disease-19 (COVID-19) infection, drugs, etc.)
- Hematopoietic system disorders, such as myelodysplastic syndrome, paroxysmal sleep hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis and so on
- Severe cardiovascular system disease, including: unstable or uncontrollable disease or condition affecting the function of the heart (such as angina pectoris, congestive heart failure, uncontrolled hypertension or arrhythmia)
- Arteriovenous thromboembolism events
- Receiving antiplatelet or anticoagulant therapy at screening
Show all 25Show fewer
- Clinically significant electrocardiogram changes
- corrected Q-T interval (QTc)>450ms for male, QTc>470ms for female
- Severe pulmonary disease, including: unstable or uncontrollable disease or condition affecting respiratory function [e.g., diffuse alveolar hemorrhage, severe pulmonary hypertension, severe pulmonary interstitial disease (peripheral blood oxygen saturation <92% at rest without oxygen, or forced vital capacity (FVC)<50%, or carbon monoxide diffusing capacity (DLCO)<50%)]
- Severe kidney disease, including: severe lupus nephritis (urinary protein > 6 g/24 hours or endogenous creatinine clearance < 30 ml /min) 8 weeks prior to randomization, active nephritis requiring current protocol disallowed drugs, severe renal insufficiency requiring hemodialysis or prednisone ≥100mg/ day (or equivalent) for ≥14 days
- SLE or non-SLE related central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) 8 weeks prior to randomization
- Active hepatitis, a history of severe liver disease. Subjects positive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus are excluded. As for subjects with antibodies to hepatitis B core antigen (HBcAb), further hepatitis B virus (HBV)-DNA should be tested. If HBV-DNA is negative, subjects could be enrolled; otherwise, subjects should be excluded
- Abnormal laboratory results (including but not limited to: alanine aminotransferase (ALT) or aspertate aminotransferase (AST)≥3×ULN (upper limit of normal), white blood cell count <1.5×10^9/L)
- Subjects with known active infections (e.g., shingles, COVID-19, HIV, active tuberculosis, etc.), and active or recurrent gastrointestinal ulcers
- Pregnant or lactating women, and subjects with a during plan during the trial
- Allergic reaction: history of allergic reactions to human biological products
- Treatment with B cell-targeting agents such as Rituximab or Epratuzumab or Belimumab six months prior to randomization
- Treatment with tumor necrosis factor (TNF) inhibitors or TNF-receptor blockers six months prior to randomization
- Participating in clinical trial 28 days or 5 drug half-lives of the investigational agents prior to randomization
- Received live vaccine 28 days prior to randomization
- Treatment with unstable dosage of thrombopoietin receptor agonists such as Eltrombopag or Romiplostim 14 days prior to randomization
- Subjects with depression or suicidal thoughts
- Previous treatment with telitacicept
- B cell targeting drug therapy is not tolerated or responsive
- Investigator considers candidates not appropriating for the study
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Xuan Zhang, MD.
Yongjing Cheng, MD.
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Jing He, MD.
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Rong Mu
- Recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan
Fen Li, MD.
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Hui Luo, MD.
- Recruiting
West China Hospital
Chengdu, Sichuan
Qibing Xie, MD.
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Niansheng Yang, MD.
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yang Li, MD.
- Recruiting
The First Affiliated Hospital of Anhui Medical College
Hefei, Anhui, 230022
Shengqian Xu, MD.
- Recruiting
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Hefei, Anhui
Zhu Chen, MD.
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Hongbin Li, MD.
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Hongsheng Sun, MD.
- Recruiting
The First People's Hospital of Yunnan
Kunming, Yunnan
Qin Li, MD.
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Dongbao Zhao, MD.
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality
Sheng Chen, MD.
- Recruiting
First Hospital of China Medical University
Shenyang, Liaoning
Pinting Yang, MD.
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Liyun Zhang, MD.
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Lei Zhang, MD.
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Wufang Qi, MD.
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Wei Wei, MD.
- Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region
Lijun Wu, MD.
- Recruiting
Wuhan Union Hospital, China
Wuhan, Hubei
Anbin Huang, MD.
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Guanmin Gao, MD., Guanmingao@zzu.edu.cn
About this study
Official title: A Randomized, Double-blind Placebo-controlled Study of Recombinant Human B Lymphocyte Stimulating Factor Receptor-Fc Fusion Protein for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.
Read the detailed description
In this randomized, double-blind placebo-controlled study, the investigators aim to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia. After screening, eligible participants will be randomized at a 1: 1 ratio to receive either subcutaneous Telitacicept 160 mg or placebo once a week for 24 weeks. The background standard therapy is maintained stable during the whole treatment period.
- Conditions
- Connective Tissue Diseases, Thrombocytopenia
- Being tested
- Telitacicept, Placebo
- Keywords
- Connective Tissue Diseases, Thrombocytopenia, biological agents, B cell, targeted therapy
- Medical subject headings
- Connective Tissue Diseases, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptBiological
Also called recombinant human B lymphocyte stimulating factor receptor-Fc fusion protein, Recombinant Human B Lymphocyte(RC18), Tai'ai®
subcutaneous telitacicept 160 mg weekly for 24 weeks.
PlaceboDrug
Also called Placebo control, control
subcutaneous placebo weekly for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept plus standard therapy | Experimental | Telitacicept (160mg ih qw for 24 weeks) combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.). Receives: Biological: Telitacicept |
| Placebo plus standard therapy | Placebo comparator | Placebo combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response (CR + PR) rate
Response is deemed as complete (CR) if the platelet (PLT) count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.
Measured: at week 24
Secondary outcomes (8)
Overall response (CR + PR) rate
Response is deemed as complete (CR) if the platelet count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.
Measured: at week 12
Rescue treatment rate
Rescue treatment is initiated if the platelet count is <10×10^9/L, or the participant is with active bleeding, or based on the investigator's judgement when the platelet count ranges from 10×10^9/L to 30×10^9/L.
Measured: at week 24
Time to rescue treatment
Time to rescue treatment refers to period duration from the initiation of Telitacicept or placebo (day 1) to rescue treatment.
Measured: at week 24
Relapse rate
No response refers to the platelet count is < 50×10^9/L, or increases for less than 1-fold from baseline, or with active central nervous system or digestive tract bleeding, or rescue treatment is initiated. Relapse is defined as no response recurring after a complete or partial response lasting for at least 7 days with treatment.
Measured: at week 24
Time to relapse
Time to relapse refers to period duration from the initiation of Telitacicept or placebo (day 1) to relapse.
Measured: at week 24
treatment related adverse event
According to the NCI CTCAE 5.0
Measured: at week 24
treatment related severe adverse event
According to the NCI CTCAE 5.0
Measured: at week 24
bleeding scale
According to the ITP bleeding scale (IBLS). The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage.
Measured: at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking University People's Hospital, Peking University Third Hospital, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, The Affiliated Hospital of Inner Mongolia Medical University, First Hospital of China Medical University, Shandong Provincial Hospital, Changhai Hospital, RenJi Hospital, Shanxi Bethune Hospital, West China Hospital, Institute of Hematology & Blood Diseases Hospital, China, Tianjin First Central Hospital, Tianjin Medical University General Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, The First People's Hospital of Yunnan
- Responsible party
- Principal investigator, Yongjing Cheng, Beijing Hospital
- Investigators
- Xuan Zhang, MD., Study chair, Beijing HospitalYongjing Cheng, MD., Study chair, Beijing HospitalShengqian Xu, MD., Principal investigator, The First Affiliated Hospital of Anhui Medical HospitalZhu Chen, MD., Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)Jing He, MD., Principal investigator, Peking University People's HospitalRong Mu, MD., Principal investigator, Peking University Third HospitalNiansheng Yang, MD., Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityYang Li, MD., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998759
- Sponsor's protocol ID
- BJ-2021-235
- Other IDs
- BJ-2021-235, RCTAIIRCTD001
- Status last verified
- May 2025
- First submitted
- 3 Aug 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Study of Recombinant Human B Lymphocyte Stimulating Factor Receptor-Fc Fusion Protein for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05998759
- Acronym / sponsor ID
- BJ-2021-235
- Conditions
- Connective Tissue Diseases, Thrombocytopenia
- Keywords
- Connective Tissue Diseases, Thrombocytopenia, biological agents, B cell, targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking University People's Hospital, Peking University Third Hospital, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, The Affiliated Hospital of Inner Mongolia Medical University, First Hospital of China Medical University, Shandong Provincial Hospital, Changhai Hospital, RenJi Hospital, Shanxi Bethune Hospital, West China Hospital, Institute of Hematology & Blood Diseases Hospital, China, Tianjin First Central Hospital, Tianjin Medical University General Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, The First People's Hospital of Yunnan
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (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 evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.
Detailed description
In this randomized, double-blind placebo-controlled study, the investigators aim to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia. After screening, eligible participants will be randomized at a 1: 1 ratio to receive either subcutaneous Telitacicept 160 mg or placebo once a week for 24 weeks. The background standard therapy is maintained stable during the whole treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept plus standard therapy | Experimental | Biological: TelitaciceptTelitacicept (160mg ih qw for 24 weeks) combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.). |
| Placebo plus standard therapy | Placebo comparator | Drug: PlaceboPlacebo combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who have been diagnosed with connective tissue disease (CTD)-associated thrombocytopenia. And CTD includes primary Sjögren syndrome (according to the 2002 American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria), systemic lupus erythematosus (SLE, according to the 1997 or the 2009 ACR classification criteria), and undifferentiated connective tissue disease (according to the 1999 international classification criteria)
- Refractory thrombocytopenia defined as:
- Either: Failure to maintain sustained remission after treatment by glucocorticoid and at least one immunosuppressant (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate, leflunomide and hydroxychloroquine, et al.) Or: Relapse during oral glucocorticoid tapering or after withdrawal
- 50×10^9/L>PLT
- anti-nuclear antibody (ANA) positive (≥1:80, any karyotype) detected in the laboratory of each research center
Key exclusion criteria (25 listed)
- Vital organ lethal bleeding (including but not limited to central nervous system bleeding, digestive tract bleeding) at screening, or intracranial bleeding 6 months prior to screening
- Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic syndrome, or thrombocytopenia secondary to other causes (such as sepsis, Epstein-Barr virus infection, cytomegalovirus infection, Corona Virus Disease-19 (COVID-19) infection, drugs, etc.)
- Hematopoietic system disorders, such as myelodysplastic syndrome, paroxysmal sleep hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis and so on
- Severe cardiovascular system disease, including: unstable or uncontrollable disease or condition affecting the function of the heart (such as angina pectoris, congestive heart failure, uncontrolled hypertension or arrhythmia)
- Arteriovenous thromboembolism events
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 |
|---|---|---|
| TelitaciceptAlso: recombinant human B lymphocyte stimulating factor receptor-Fc fusion protein, Recombinant Human B Lymphocyte(RC18), Tai'ai®subcutaneous telitacicept 160 mg weekly for 24 weeks. | Biological | Telitacicept plus standard therapy |
| PlaceboAlso: Placebo control, controlsubcutaneous placebo weekly for 24 weeks. | Drug | Placebo plus standard therapy |
Primary outcome
Overall response (CR + PR) rate
Time frame: at week 24
Response is deemed as complete (CR) if the platelet (PLT) count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.
8 secondary outcomes
Overall response (CR + PR) rate
Time frame: at week 12
Rescue treatment rate
Time frame: at week 24
Time to rescue treatment
Time frame: at week 24
Relapse rate
Time frame: at week 24
Time to relapse
Time frame: at week 24
treatment related adverse event
Time frame: at week 24
treatment related severe adverse event
Time frame: at week 24
bleeding scale
Time frame: at week 24
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 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuan Zhang, MD. study chair
Beijing Hospital
Yongjing Cheng, MD. study chair
Beijing Hospital
Shengqian Xu, MD. principal investigator
The First Affiliated Hospital of Anhui Medical Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telitacicept in people with Connective Tissue Diseases and Thrombocytopenia, run by Beijing Hospital at 23 sites 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 7 inclusion and 25 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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. 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.
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 Xuan Zhang, MD. (+86-01085136736, zxpumch2003@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (CR + PR) rate (time frame: at week 24). 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 6 May 2025.