Non-alcoholic SteatohepatitisPhase 2NCT06569524
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
A Phase 2 study of Non-alcoholic Steatohepatitis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 53 sites in China.
Trial summary
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 53 sitesChina
- Study dates
- 14 Sep 2023to Dec 2027
- 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
- Must be willing to participate in the study and provide written informed consent.
- Male or female aged 18 ≤ age < 75 at the time of signing the informed consent.
- Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.
- Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).
- Weight changes≤5% in the 6 weeks prior to randomization.
- No qualitative change in dose for the drugs listed below:
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- Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months
- Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
- Statins: for at least 3 months
- Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 6 month after treatment discontinuation.
Who cannot join
- Documented causes of chronic liver disease other than NASH
- Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening，Fasting blood glucose≥13.9mmol/l
- Uncontrolled hypertension at Screening (values ≥160/100 mm Hg)
- History or presence of cirrhosis
- Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
- Unable or unwilling to undergo liver biopsy according to research requirements.
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- History of weight loss surgery within 5 years (inclusive) prior to screening
- A major surgery was performed 3 months prior to signing the Informed Consent Form (ICF), or planned during the study period.
- Have experienced any bone trauma, fracture, or bone surgery within ≤ 2 months prior to screening.
- When screening, according to the results of dual energy X-ray absorptiometry (DXA) examination, it meets the criteria for osteoporosis: T≤ -2.5
- Recent history of drug abuse (defined as ≤ 2 years).
- Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening.
- Abnormal laboratory test values：ALT or AST >5 × ULN；Serum ALP≥2× ULN；eGFR<60mL/min；INR>1.3× ULN；platelets < LLN.
- Pregnant or breastfeeding women.
- Liver transplantation history or planned liver transplantation
- Contraindications for MRI examination
- Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
Trial locations and contacts
53 sites in 1 country. Contact the study team or a site near you to ask about taking part.
53 sites in 1 country
China53 sites, 53 recruiting
- Not yet recruiting
Baoding First Central Hospital
Baoding, Hebei, 071030
Yingxia Hao, Master, 18617789023, hyxxh2@126.com
- Not yet recruiting
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Jing Zhang, Doctor, 13391859683, drzhangjing@163.com
- Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, 061012
Sichen Wei, Master, 18531707600, ssw1968@126.com
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Zhenjing Jin, Doctor, 13604310429, jinyu0429@sina.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Yongfang Jiang, Doctor, 13875858624, jiangyongfang@csu.edu.cn
- Not yet recruiting
Chifeng Hospital
Chifeng, Inner Mongolia, 024099
Ruimiao Yu, Bachelor, 18047668282, yuruimiao511@qq.com
- Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
Liqing Zheng, Doctor, 15305918043, wom70@163.com
- Not yet recruiting
Ganzhou Fifth People's Hospital
Ganzhou, Jiangxi, 341099
Fei Xu, Doctor, 13307978586, xufei8586@163.com
- Not yet recruiting
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310022
Guoping Sheng, Doctor, 15990006685, Guoping.sheng@shulan.com
- Not yet recruiting
Rui'an People's Hospital
Hangzhou, Zhejiang, 325200
Liang Hong, Bachelor, 13958805550, rahoshongliang@163.com
- Not yet recruiting
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214499
Shuanghai Liu, Doctor, 18921233155, shuanghailiu@126.com
- Not yet recruiting
Leshan People's Hospital
Leshan, Sichuan, 614099
Xianfei Zhong, Master, 13981302161, 3180721434@qq.com
- Not yet recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Sikui Wang, Doctor, 13346258113, Wangsk1966@sina.com
- Not yet recruiting
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 545005
Cunli Nong, Master, 13877286608, 12558755699@qq.com
- Not yet recruiting
Liuzhou Liutie Central Hospital
Liuzhou, Guangxi, 545007
Jingbin Wei, Master, 15877260861, weijingbin@163.com
- Not yet recruiting
Lu'an Traditional Chinese Medicine Hospital
Lu'an, Anhui, 237000
Junfeng Lu, Bachelor, 13605640145, forestar8592980@163.com
- Not yet recruiting
Lu'an People's Hospital
Lu'an, Anhui, 237121
Hongnian Pan, Bachelor, 13965495835, Pzxbb945@sina.com
- Not yet recruiting
Luoyang Central Hospital
Luoyang, Henan, 471000
Guoqiang Zhang, Master, 13592090028, 13592090028@163.com
- Not yet recruiting
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, 646099
Qing Peng, Doctor, 18181873310, pq9712118@163.com
Mingming Deng, Doctor, 18989131797, 793070544@qq.com
- Not yet recruiting
Meishan People's Hospital
Meishan, Sichuan, 620000
Hui Deng, Bachelor, 13778888362, 3431281705@qq.com
- Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621099
Xiaoan Li, Doctor, 13880868858, 435445611@qq.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210003
Li Dong, Bachelor, 13512501015, lilid1973@sina.com
- Not yet recruiting
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, 315040
Lanman Xu, Doctor, 13587646315, 13587646315@163.com
- Not yet recruiting
Puer People's Hospital
Puer, Yunnan, 665099
Bing Zhao, Doctor, 15305045958, 929843941@qq.com
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Aifeng Yang, Bachelor, 13721756703, w95159@163.com
- Not yet recruiting
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
Qingyuan, Guangzhou, 511436
Qiya Huang, Master, 13926665054, 7719738@qq.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030
Duowu Zou, Doctor, 13901607608, zdw_clinpharmacol@163.com
- Not yet recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200050
Qin Zhang, Doctor, 021-52039999-79305, gcpjgb@163.com
- Not yet recruiting
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, 200135
Yihai Shi, Doctor, 18918157268, 732791146@qq.com
- Not yet recruiting
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399
Wujun Xiong, Doctor, 13916617586, xiongwujun@126.com
- Not yet recruiting
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110000
Rui Zhao, Master, 18502460033, 11446555@qq.com
- Not yet recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110022
Yang Ding, Doctor, 13332434847, yding0903@sina.com
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Yaqin Lin, Bachelor, 19977204782, w252984027@163.com
- Not yet recruiting
Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050024
Wenfang Yuan, Master, 13313019790, 413699442@qq.com
- Not yet recruiting
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, 052360
Huanwei Zheng, Doctor, 13323119317, zhwsjzsz@163.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 050081
Shiwei Liu, Doctor, 13191072733, lswspring6@aliyun.com
- Not yet recruiting
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Hui Guo, Bachelor, 15822213611, guohui3105@163.com
- Not yet recruiting
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, Hubei, 448000
Bin Cheng, Doctor, 13986097542, 1737769373@qq.com
- Not yet recruiting
Wuwei Cancer Hospital of Gansu Province
Wuwei, Gansu, 100069
Wenhua Zhang, Bachelor, 18993531188, 925944468@qq.com
- Not yet recruiting
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, 214001
Zheng Wang, Doctor, 13706196992, wangzheng79@sina.com
- Not yet recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710000
Feng Ye, Doctor, 18991232860, Yefeng.jiaotong@163.com
- Not yet recruiting
Xiamen Traditional Chinese Medicine Hospital
Xiamen, Fujian, 361000
Qingfa Ruan, Master, 15305045958, ruanqingfa@aliyun.com
- Not yet recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Fang Ji, Doctor, 13270358629, 3472629746@qq.com
- Not yet recruiting
Yiwu Central Hospital
Yiwu, Zhejiang, 322099
Dong Yan, Doctor, 15906607100, yandonh@163.com
- Not yet recruiting
Yueyang Central Hospital
Yueyang, Hunan, 414020
Mingjuan Yuan, Master, 17347533600, yuan1387598@163.com
- Not yet recruiting
YuLin Red Cross Hospital
Yulin, Guangxi, 537099
Yu Wang, Master, 13197753413, 302827349@qq.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Jia Shang, Bachelor, 13938401888, shangjia666@126.com
- Not yet recruiting
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, 450015
Guangming Li, Master, 13603715881, lgm177@sina.com
- Not yet recruiting
Zhengzhou Third People's Hospital
Zhengzhou, Henan, 450099
Dan Zhao, Master, 13778888362, 3431281705@qq.com
- Not yet recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
Min Xu, Doctor, 15862990603, Peterxu1974@163.com
- Not yet recruiting
Zhoukou Central Hospital
Zhoukou, Zhoukou, 466099
Junying Liu, Doctor, 18539768877, liujunying781025@163.com
- Not yet recruiting
Zhoushan Hospital
Zhoushan, Zhejiang, 316100
Qiujing Wang, Master, 13857224785, qiujing726@163.com
- Not yet recruiting
The First People's Hospital of Zigong City
Zigong, Sichuan, 643000
Chunfang You, Master, 13990095625, youchunfang2011@163.com
Huang Zhong, Master, 13684321320, 89324139@qq.com
About this study
Official title: A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- TQA2225/AP025 or TQA2225/AP025 Placebo 25mg, TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQA2225/AP025 or TQA2225/AP025 Placebo 25mgDrug
To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
TQA2225/AP025 or TQA2225/AP025 Placebo 50mgDrug
To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
| Study group | Role | What they receive |
|---|---|---|
| TQA2225/AP025 or TQA2225/AP025 Placebo 25mg | Experimental | TQA2225/AP025 or TQA2225/AP025 Placebo administered 25mg by subcutaneous (SC) injection weekly for 48 weeks Receives: Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg |
| TQA2225/AP025 or TQA2225/AP025 Placebo 50mg | Experimental | TQA2225/AP025 or TQA2225/AP025 Placebo administered 50mg by subcutaneous (SC) injection weekly for 48 weeks Receives: Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline
- Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR
- Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
Measured: After week 48 of TQA2225/AP025 treatment
Secondary outcomes (1)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and percentage of adverse events and serious adverse events
Measured: Baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start14 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569524
- Sponsor's protocol ID
- TQA2225-II-01
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT06569524
- Acronym / sponsor ID
- TQA2225-II-01
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 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.
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)
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 |
|---|---|---|
| TQA2225/AP025 or TQA2225/AP025 Placebo 25mg | Experimental | Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 25mgTQA2225/AP025 or TQA2225/AP025 Placebo administered 25mg by subcutaneous (SC) injection weekly for 48 weeks |
| TQA2225/AP025 or TQA2225/AP025 Placebo 50mg | Experimental | Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 50mgTQA2225/AP025 or TQA2225/AP025 Placebo administered 50mg by subcutaneous (SC) injection weekly for 48 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be willing to participate in the study and provide written informed consent.
- Male or female aged 18 ≤ age < 75 at the time of signing the informed consent.
- Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.
- Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).
- Weight changes≤5% in the 6 weeks prior to randomization.
Key exclusion criteria (17 listed)
- Documented causes of chronic liver disease other than NASH
- Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening，Fasting blood glucose≥13.9mmol/l
- Uncontrolled hypertension at Screening (values ≥160/100 mm Hg)
- History or presence of cirrhosis
- Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
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 |
|---|---|---|
| TQA2225/AP025 or TQA2225/AP025 Placebo 25mgTo evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH) | Drug | TQA2225/AP025 or TQA2225/AP025 Placebo 25mg |
| TQA2225/AP025 or TQA2225/AP025 Placebo 50mgTo evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH) | Drug | TQA2225/AP025 or TQA2225/AP025 Placebo 50mg |
Primary outcome
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline
Time frame: After week 48 of TQA2225/AP025 treatment
1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR 2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
1 secondary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to week 48
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 26 Aug 2024.
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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.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Non-alcoholic Steatohepatitis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 53 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 10 inclusion and 17 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 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. 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 Junqi Niu, Doctor (13756661205, junqiniu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline (time frame: After week 48 of TQA2225/AP025 treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.