Multidrug Resistant TuberculosisPhase 3INSPIRE-TBNCT05081401
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
A Phase 3 study testing Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z, A1 and A2a in people with Multidrug Resistant Tuberculosis and Rifampicin Resistant Tuberculosis, run by Huashan Hospital at 5 sites in China.
Trial summary
The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis, Pre-XDR-TB
- What is being tested?
- Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z, A1 and A2a
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 5 sitesChina
- Study dates
- 23 May 2022to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;
- Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;
- Signed informed consent form (ICF).
Who cannot join
- Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;
- Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;
- Patients known to be pregnant or breastfeeding at the time of enrollment;
- Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
- Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Guiyang Public Health Treatment Center
Guiyang, Guizhou
Zhongfeng Huang, 1017899870@qq.com
- Recruiting
People's Hospital of Qiandongnan
Kaili, Guizhou
Jing Wang
- Recruiting
The Third People's Hospital of Liupanshui
Liupanshui, Guizhou
Chunlong Zhang
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, PhD, MD, +86 21 52889999 ext. 8123, zhangwenhong@fudan.edu.cn
Feng Sun
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
Jianyong Zhang
About this study
The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones
Read the detailed description
RR-TB patients susceptible to fluoroquinolones are identified with the Xpert MTB/XDR assay (Cepheid; Sunnyvale, CA, USA). Experimental arms are seven oral regimens with a five-drug combination of the following: bedaquiline, linezolid, a fluoroquinolone (moxifloxacin or levofloxacin), cycloserine, clofazimine, and pyrazinamide.To minimize potential toxicity, each regimen includes no more than two major QT-prolonging drugs (bedaquiline, clofazimine, and moxifloxacin). Treatment duration of the experimental regimens is 9 months. A 2-month extension of treatment is allowed with the presence of cavities at month 9 or in case of a positive culture at month 2. Baseline molecular drug susceptibility test (DST) of pyrazinamide will be performed using whole gene sequencing (WGS) technique. The result of molecular DST of pyrazinamide will be interpreted by technical staff at central laboratory of Huashan Hospital, Fudan University. Once a participant is proved resistant to pyrazinamide by WGS results at baseline, pyrazinamide will be discontinued with no need for extra drug replacement. The control regimen for RR-TB patients susceptible to fluoroquinolones is the current SOC oral regimen recommended by the national guidelines.
Pre-XDR TB patients are identified with the Xpert MTB/XDR assay. The experimental arm is a 9-month regimen consisting of bedaquiline, cycloserine, clofazimine, linezolid, and pyrazinamide. Treatment extension to 11 months is allowed with the presence of cavities at month 9 or in case of a positive culture at month 2. Pyrazinamide will be discontinued from the study regimen if baseline molecular DST results reveal pyrazinamide resistance. The comparator is a conventional longer regimen (20 months) consistent with the national guidelines.
- Being tested
- Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z, A1, A2a, A2b, A2c
- Keywords
- multidrug resistant tuberculosis, shorter treatment, all-oral regimen, PZA sensitivity
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+ZCombination product
A-SOC: 4Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z/5Lfx(Mfx)+Cfz(Cs)+E+Z During the intensive phase: Bedaquiline(Linezolid);Levofloxacin(Moxifloxacin) All treatment is taken orally
A1Combination product
9Bdq(6m)+Fq+Lzd+Cs+Cfz
A2aCombination product
9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z
A2bCombination product
9Bdq(6m)+Fq+Lzd(2m)+Cs+Z
A2cCombination product
9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z
A3Combination product
9Bdq(6m)+Fq+Lzd+Cfz+Z
A4Combination product
9Bdq(6m)+Fq+Cfz+Cs+Z
A5Combination product
9Fq+Lzd+Cfz+Cs+Z
B-SOCCombination product
6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs
B1Combination product
9Bdq(6m)+Lzd+Cs+Cfz+Z
| Study group | Role | What they receive |
|---|---|---|
| A-SOC | Active comparator | The control arm for fluroquinolones susceptible participants is the current standard of care oral regimen for RR-TB recommended by Chinese national guidelines. The SOC regimen comprise one or two group A drugs(bedaquiline or linezolid, moxifloxacin or levofloxacin) and one group B drug(clofazimine or cycloserine) along with other companion drugs. Receives: Combination Product: Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z |
| A1 | Experimental | The experimental A1 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, clofazimine. Receives: Combination Product: A1 |
| A2a | Experimental | The experimental A2a arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 9 months. Receives: Combination Product: A2a |
| A2b | Experimental | The experimental A2b arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 2 months. Receives: Combination Product: A2b |
| A2c | Experimental | The experimental A2c arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 2 months and then 300mg daily for 7 months. Receives: Combination Product: A2c |
| A3 | Experimental | The experimental A3 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), clofazimide, pyrazinamide. Receives: Combination Product: A3 |
| A4 | Experimental | The experimental A4 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, fluroquinolones(moxifloxacin or levofloxacin), clofazimide, cycloserine, pyrazinamide. Receives: Combination Product: A4 |
| A5 | Experimental | The experimental A4 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of fluroquinolones(moxifloxacin or levofloxacin), linezolid, clofazimide, cycloserine, pyrazinamide. Receives: Combination Product: A5 |
| B-SOC | Active comparator | In fluroquinolones resistant participants, the comparator is a locally approved standard of care long regimen which is consistent with local guidelines for treatment of RR-TB in China and WHO recommendations. The control arm contain bedaquiline, cycloserine, clofazimine, and linezolid. Treatment duration is 20 months, with a 6-month intensive phase and a 14-month continuation phase. Receives: Combination Product: B-SOC |
| B1 | Experimental | In fluroquinolones resistant participants, the arm B1 is a 9-month treatment regimen with a combination of five drugs: bedaquiline, cycloserine, clofazimine, linezolid, pyrazinamide. Receives: Combination Product: B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
a favorable outcome at the end of study
A favorable outcome is defined by the absence of previous unfavorable, and the last two culture results are negative. These two cultures must be taken from respiratory samples collected on separate visits at least 7 days apart. The latest culture sample should be collected between month 21 and 23.
Measured: at 21 months after randomization
Secondary outcomes (6)
The median time to sputum culture conversion
Time from treatment initiation to the first of two consecutive negative sputum culture conversion without an intervening positive culture.
Measured: at 21 months after randomization
The proportion of participants with grade 3 or higher AEs, SAEs
To compare the proportion of patients who experience grade 3 or greater adverse events (AE graded according to the Common terminology criteria for adverse events, version 5.0), during treatment or follow-up in safety population.
Measured: at 21 months after randomization
All-cause mortality and treatment relevant mortality
To compare the death rate and treatment relevant death rate during treatment or follow-up in safety population.
Measured: at 21 months after randomization
The proportion of participants with treatment relevant SAEs
To compare the proportion of patients treatment relevant SAEs, during treatment or follow-up in safety population.
Measured: at 21 months post-randomization
The proportion of participants with grade 3 or higher QTc prolongation
To compare the proportion of patients treatment relevant SAEs, during treatment or follow-up in safety population.
Measured: at 21 months after randomization
The proportion of participants experiencing permanent drug discontinuation or replacement due to QTc prolongation
To compare the proportion of patients experiencing permanent drug discontinuation or replacement due to QTc prolongation, during treatment or follow-up in safety population.
Measured: at 21 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start23 May 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistant TuberculosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, PHD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081401
- Sponsor's protocol ID
- INSPIRE-TB
- Acronym
- INSPIRE-TB
- Status last verified
- Apr 2025
- First submitted
- 5 Oct 2021
- Last updated
- 6 Apr 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
- ClinicalTrials.gov ID
- NCT05081401
- Acronym / sponsor ID
- INSPIRE-TB / INSPIRE-TB
- Keywords
- multidrug resistant tuberculosis, shorter treatment, all-oral regimen, PZA sensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Oct 2021 (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 INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones
Detailed description
RR-TB patients susceptible to fluoroquinolones are identified with the Xpert MTB/XDR assay (Cepheid; Sunnyvale, CA, USA). Experimental arms are seven oral regimens with a five-drug combination of the following: bedaquiline, linezolid, a fluoroquinolone (moxifloxacin or levofloxacin), cycloserine, clofazimine, and pyrazinamide.To minimize potential toxicity, each regimen includes no more than two major QT-prolonging drugs (bedaquiline, clofazimine, and moxifloxacin). Treatment duration of the experimental regimens is 9 months. A 2-month extension of treatment is allowed with the presence of cavities at month 9 or in case of a positive culture at month 2. Baseline molecular drug susceptibility test (DST) of pyrazinamide will be performed using whole gene sequencing (WGS) technique. The result of molecular DST of pyrazinamide will be interpreted by technical staff at central laboratory of Huashan Hospital, Fudan University. Once a participant is proved resistant to pyrazinamide by WGS results at baseline, pyrazinamide will be discontinued with no need for extra drug replacement. The control regimen for RR-TB patients susceptible to fluoroquinolones is the current SOC oral regimen recommended by the national guidelines.
Pre-XDR TB patients are identified with the Xpert MTB/XDR assay. The experimental arm is a 9-month regimen consisting of bedaquiline, cycloserine, clofazimine, linezolid, and pyrazinamide. Treatment extension to 11 months is allowed with the presence of cavities at month 9 or in case of a positive culture at month 2. Pyrazinamide will be discontinued from the study regimen if baseline molecular DST results reveal pyrazinamide resistance. The comparator is a conventional longer regimen (20 months) consistent with the national guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A-SOC | Active comparator | Combination Product: Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+ZThe control arm for fluroquinolones susceptible participants is the current standard of care oral regimen for RR-TB recommended by Chinese national guidelines. The SOC regimen comprise one or two group A drugs(bedaquiline or linezolid, moxifloxacin or levofloxacin) and one group B drug(clofazimine or cycloserine) along with other companion drugs. |
| A1 | Experimental | Combination Product: A1The experimental A1 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, clofazimine. |
| A2a | Experimental | Combination Product: A2aThe experimental A2a arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 9 months. |
| A2b | Experimental | Combination Product: A2bThe experimental A2b arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 2 months. |
| A2c | Experimental | Combination Product: A2cThe experimental A2c arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 2 months and then 300mg daily for 7 months. |
| A3 | Experimental | Combination Product: A3The experimental A3 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), clofazimide, pyrazinamide. |
| A4 | Experimental | Combination Product: A4The experimental A4 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, fluroquinolones(moxifloxacin or levofloxacin), clofazimide, cycloserine, pyrazinamide. |
| A5 | Experimental | Combination Product: A5The experimental A4 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of fluroquinolones(moxifloxacin or levofloxacin), linezolid, clofazimide, cycloserine, pyrazinamide. |
| B-SOC | Active comparator | Combination Product: B-SOCIn fluroquinolones resistant participants, the comparator is a locally approved standard of care long regimen which is consistent with local guidelines for treatment of RR-TB in China and WHO recommendations. The control arm contain bedaquiline, cycloserine, clofazimine, and linezolid. Treatment duration is 20 months, with a 6-month intensive phase and a 14-month continuation phase. |
| B1 | Experimental | Combination Product: B1In fluroquinolones resistant participants, the arm B1 is a 9-month treatment regimen with a combination of five drugs: bedaquiline, cycloserine, clofazimine, linezolid, pyrazinamide. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;
- Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;
- Signed informed consent form (ICF).
Key exclusion criteria (5 listed)
- Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;
- Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;
- Patients known to be pregnant or breastfeeding at the time of enrollment;
- Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
- Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.
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 |
|---|---|---|
| Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+ZA-SOC: 4Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z/5Lfx(Mfx)+Cfz(Cs)+E+Z During the intensive phase: Bedaquiline(Linezolid);Levofloxacin(Moxifloxacin) All treatment is taken orally | Combination product | A-SOC |
| A19Bdq(6m)+Fq+Lzd+Cs+Cfz | Combination product | A1 |
| A2a9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z | Combination product | A2a |
| A2b9Bdq(6m)+Fq+Lzd(2m)+Cs+Z | Combination product | A2b |
| A2c9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z | Combination product | A2c |
| A39Bdq(6m)+Fq+Lzd+Cfz+Z | Combination product | A3 |
| A49Bdq(6m)+Fq+Cfz+Cs+Z | Combination product | A4 |
| A59Fq+Lzd+Cfz+Cs+Z | Combination product | A5 |
| B-SOC6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs | Combination product | B-SOC |
| B19Bdq(6m)+Lzd+Cs+Cfz+Z | Combination product | B1 |
Primary outcome
a favorable outcome at the end of study
Time frame: at 21 months after randomization
A favorable outcome is defined by the absence of previous unfavorable, and the last two culture results are negative. These two cultures must be taken from respiratory samples collected on separate visits at least 7 days apart. The latest culture sample should be collected between month 21 and 23.
6 secondary outcomes
The median time to sputum culture conversion
Time frame: at 21 months after randomization
The proportion of participants with grade 3 or higher AEs, SAEs
Time frame: at 21 months after randomization
All-cause mortality and treatment relevant mortality
Time frame: at 21 months after randomization
The proportion of participants with treatment relevant SAEs
Time frame: at 21 months post-randomization
The proportion of participants with grade 3 or higher QTc prolongation
Time frame: at 21 months after randomization
The proportion of participants experiencing permanent drug discontinuation or replacement due to QTc prolongation
Time frame: at 21 months after randomization
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 Apr 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.
Wenhong Zhang, PHD principal investigator
Huashan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z, A1 and A2a in people with Multidrug Resistant Tuberculosis and Rifampicin Resistant Tuberculosis, run by Huashan Hospital at 5 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 3 inclusion and 5 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 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Sun, Dr. ((086)15921403893, feng.sun@nmcid.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a favorable outcome at the end of study (time frame: at 21 months after randomization). 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 Apr 2025.