Tuberculosis, PulmonaryPhase 4NCT04766307
A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2
A Phase 4 study testing Interleukin-2 in people with Tuberculosis, Pulmonary, run by Beijing Chest Hospital at 16 sites in China.
Trial summary
The purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2HRZE/4HR plus IL-2 and standard regimen 2HRZE/4HR for newly diagnosed smear positive pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 16 sitesChina
- Study dates
- 20 Jul 2016to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
- Is aged 18-65 years.
- Chest X-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum X-pert positive.
- Newly diagnosed cases receiving anti-TB treatment for less than one month.
- No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months.
- the urine analysis of Women of childbearing age are negative and agree to use the efficient contraception during the study period.
Who cannot join
- Has a known allergy to any drug of treatment regimens.
- There are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (ALT or AST levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. Platelets less than 50x109/L.
- Complication with Diabetic.
- The screening diagnosis was isoniazid resistance or rifampin resistance
- There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state.
- Is known to be pregnant or breast-feeding.
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- Karnofsky score is less than 50%.
- Is taking any clinical trial in the past 3 months.
- Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
- HIV is positive or AIDS patients.
- Has Non tuberculous mycobacterial lung disease.
- Merge with extra pulmonary tuberculosis.
Trial locations and contacts
16 sites in 1 country.
Naihui Chu, PhD contact
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
the central hospital of Changsha
Changsha, Hunan, 410000
chunxiang Li, 13055161267
- Recruiting
Dalian Tuberculosis Hospital
Dalian, Liaoning, 110000
Qing Ji, 13009482267
- Recruiting
the Second hospital of Fuyang
Fuyang, Anhui, 230000
haiqing Liu, 13855894607
- Recruiting
Fuzhou Chest Hospital
Fuzhou, Fujian, 350000
xiaohong Chen, 13275013012
- Recruiting
Guiyang Public Health Treatment Center
Guiyang, Guizhou, 550000
jing Chen, 13985410691
- Recruiting
The Infectious Hospital of Handan
Handan, Hebei, 056000
chunyan Zhang, 15803200615
- Recruiting
Jiamusi Insititute For Tuberculosis Control
Jiamusi, Heilongjiang, 154000
chao Qiu, 13039651567
- Recruiting
The Infectious Hospital of mudanjiang
Mudanjiang, Heilongjiang, 150000
lixiang Chu, 18645753107
- Recruiting
Jiangxi Chest Hospital
Nanchang, Jiangxi, 330000
aihua Deng, 13307096301
- Recruiting
the people's hospital of Jiangsu province
Nanjing, Jiangsu, 210000
hong Wang
- Recruiting
Qingdao Chest Hospital
Qingdao, Shandong, 266000
yufeng Liu
13863985511
- Recruiting
Shenzhen third people's Hospital
Shenzhen, Guangzhou, 518000
qunyi Deng, 13823145706
- Recruiting
Hebei Chest Hospital
Shijiazhuang, Hebei, 050000
zhihui Li, 13833465658, lzhihui2011@126.com
- Recruiting
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, 030000
quanhong Wang, 13934242762
- Recruiting
Xian Chest Hospital
Xi’an, Shanxi, 710000
liyun Dang, 18091888085
- Recruiting
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, 450000
yu Chen, 13823145706
About this study
Official title: A Randomized Multicenter Clinical Trial of a New Treatment for Primary Smear- Positive Pulmonary Tuberculosis With Interleukin-2
The purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2HRZE/4HR plus IL-2 and standard regimen 2HRZE/4HR for newly diagnosed smear positive pulmonary tuberculosis.
Read the detailed description
- Design:The study is a multi-center, randomized, controlled, open clinical trial.
- Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria.
- Investigational regimens: Experimental group regimen:2HRZE/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） The control group regimen: 2HRZE/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
- Primary and Secondary outcome measures: primary efficacy outcome measures:(a)Negative conversion rate of sputum bacteria. (b)Sputum smear conversion proportion at the treatment completion . secondary efficacy outcome measure:Recurrence rate after treatment.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Interleukin-2
- Keywords
- pulmonary tuberculosis, interleukin-2, clinical trial
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2Drug
Also called IL-2
Interleukin 2 (IL-2) is a pleiotropic cytokine that is produced after antigen activation and plays crucial roles in the immune response. IL-2 secreted by activated T cells is central to the development of an immune response to infection, promoting the differentiation and proliferation of lymphoid cells. This hydrophobic molecule and the various cytokines that it elicits regulates the behavior of T and B lymphocytes, monocytes/macrophages, natural killer (NK) cells, and neutrophils. IL-2 therapy regimens are expected to limit mycobacterial replication. Early clinical trials with IL-2 demonstrated that IL-2 immunotherapy may be useful in controlling infectious disease.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Experimental group regimen:2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month）
Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). Receives: Drug: Interleukin-2 |
| Control regimen group | Active comparator | The control group regimen: 2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR
Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). Receives: Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment.
Measured: two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start20 Jul 2016
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chu naihu, Beijing Chest Hospital
- Investigators
- Naihui Chu, PhD, Principal investigator, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766307
- Sponsor's protocol ID
- 2015ZX10003001-002
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Clinical Trial of a New Treatment for Primary Smear- Positive Pulmonary Tuberculosis With Interleukin-2
- ClinicalTrials.gov ID
- NCT04766307
- Acronym / sponsor ID
- 2015ZX10003001-002
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- pulmonary tuberculosis, interleukin-2, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Feb 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 purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2HRZE/4HR plus IL-2 and standard regimen 2HRZE/4HR for newly diagnosed smear positive pulmonary tuberculosis.
Detailed description
- Design:The study is a multi-center, randomized, controlled, open clinical trial.
- Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria.
- Investigational regimens: Experimental group regimen:2HRZE/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） The control group regimen: 2HRZE/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
- Primary and Secondary outcome measures: primary efficacy outcome measures:(a)Negative conversion rate of sputum bacteria. (b)Sputum smear conversion proportion at the treatment completion . secondary efficacy outcome measure:Recurrence rate after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Interleukin-2Experimental group regimen:2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). |
| Control regimen group | Active comparator | Drug: Interleukin-2The control group regimen: 2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
- Is aged 18-65 years.
- Chest X-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum X-pert positive.
- Newly diagnosed cases receiving anti-TB treatment for less than one month.
- No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months.
Key exclusion criteria (12 listed)
- Has a known allergy to any drug of treatment regimens.
- There are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (ALT or AST levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. Platelets less than 50x109/L.
- Complication with Diabetic.
- The screening diagnosis was isoniazid resistance or rifampin resistance
- There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state.
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 |
|---|---|---|
| Interleukin-2Also: IL-2Interleukin 2 (IL-2) is a pleiotropic cytokine that is produced after antigen activation and plays crucial roles in the immune response. IL-2 secreted by activated T cells is central to the development of an immune response to infection, promoting the differentiation and proliferation of lymphoid cells. This hydrophobic molecule and the various cytokines that it elicits regulates the behavior of T and B lymphocytes, monocytes/macrophages, natural killer (NK) cells, and neutrophils. IL-2 therapy regimens are expected to limit mycobacterial replication. Early clinical trials with IL-2 demonstrated that IL-2 immunotherapy may be useful in controlling infectious disease. | Drug | Control regimen group, experimental group |
Primary outcome
The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
Time frame: two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase).
A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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. This study is not recruiting at the moment.
Naihui Chu, PhD contact
Naihui Chu, PhD principal investigator
Beijing Chest Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interleukin-2 in people with Tuberculosis, Pulmonary, run by Beijing Chest Hospital at 16 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naihui Chu, PhD (dongchu1994@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment. (time frame: two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase).). 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 23 Feb 2021.