Silicosis TuberculosisTBNCT03900858
Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
A study testing Isoniazid；Rifapentine in people with Silicosis Tuberculosis, run by Huashan Hospital at 1 site in China.
Trial summary
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Silicosis Tuberculosis
- What is being tested?
- Isoniazid；Rifapentine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Jun 2022
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with Silica exposure or diagnosed with silicosis;
- Age between 18 to 65 years;
- Willing to provide signed informed consent, or parental consent and participant assent.
Who cannot join
- Clinical or culture confirmed active TB;
- A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years;
- A documented history of a completing an adequate course of treatment for active TB or latent TB infection;
- Allergy to Isoniazid, Rifampin, or Rifapentine;
- Human immunodeficiency virus (HIV) infection;
- History of hepatitis B/C infection or liver cirrhosis;
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- Serum Aspartic transaminase (AST) or alanine transaminase (ALT) > 2x upper limit of normal or total bilirubin >2.5 mg/dL;
- Receiving immunosuppressants or biological agents;
- Life expectancy <3 years;
- Mental disorder;
- Participated in other clinical trials in recent three months;
- Other conditions that investigates consider not suitable for participate.
Trial locations and contacts
1 site in 1 country.
Wenhong Zhang, MD，PhD contact
China1 site, 1 recruiting
- Recruiting
Wenling No.1 People's Hospital, Zhejiang
Taizhou, Zhejiang, 317500
Miaoyao Ling, MD, +86576-89668099, lmy120904@sina.com
Xitian Huang, MD
About this study
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
Read the detailed description
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. For preventive therapy, alternative shortened courses such as 1-month daily rifapentine and isoniazid have been evaluated in HIV-infected individuals for its non-inferiority, safety and convenience compared with traditional monotherapy. And the treatment completion rate is higher. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
- Conditions
- Silicosis Tuberculosis
- Being tested
- Isoniazid；Rifapentine
- Keywords
- rifapentine, isoniazid, preventive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoniazid；RifapentineDrug
Also called Isoniazid I INH, Rifapentine RPT, 1RPT/INH 1HP
1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation
| Study group | Role | What they receive |
|---|---|---|
| Isoniazid/ Rifapentine 3 times a week | Experimental | Intervention：Isoniazid/ Rifapentine 3 times a week given by DOT oral Rifapentine (450mg) plus Isoniazid (400mg) for 12 doses Receives: Drug: Isoniazid；Rifapentine |
| No Intervention | No intervention | No preventive treatment Follow up without intervention. Have already done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
Measured: 3 years
Secondary outcomes (3)
Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH
Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH
Measured: up to 30 days after the last dose of study drug
Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH
Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH
Measured: up to 30 days after the last dose of study drug
Percentage of participants who complete the treatment regimen
Percentage of participants who complete the treatment regimen
Measured: Enrollment up to Month 1 (1RPT/INH)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Silicosis 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, MD，PhD, Principal investigator, Huashan Hospital of Fudan University，Shanghai，China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900858
- Sponsor's protocol ID
- 2017ZX10201302-004
- Acronym
- TB
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruan QL, Yang QL, Ma CL, Lin MY, Huang XT, Mao YP, Gao JM, Li JJ, Zhang XN, You ZX, Zheng QQ, Ren YF, Liu XF, Shao LY, Zhang WH. Efficacy and safety of a novel short course rifapentine and isoniazid regimen for the preventive treatment of tuberculosis in Chinese silicosis patients: a pilot study (SCRIPT-TB). Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16.
PubMed 40326358
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
- ClinicalTrials.gov ID
- NCT03900858
- Acronym / sponsor ID
- TB / 2017ZX10201302-004
- Conditions
- Silicosis Tuberculosis
- Keywords
- rifapentine, isoniazid, preventive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 3 Apr 2019 (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.
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
Detailed description
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. For preventive therapy, alternative shortened courses such as 1-month daily rifapentine and isoniazid have been evaluated in HIV-infected individuals for its non-inferiority, safety and convenience compared with traditional monotherapy. And the treatment completion rate is higher. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoniazid/ Rifapentine 3 times a week | Experimental | Drug: Isoniazid；RifapentineIntervention：Isoniazid/ Rifapentine 3 times a week given by DOT oral Rifapentine (450mg) plus Isoniazid (400mg) for 12 doses |
| No Intervention | No intervention | –No preventive treatment Follow up without intervention. Have already done. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with Silica exposure or diagnosed with silicosis;
- Age between 18 to 65 years;
- Willing to provide signed informed consent, or parental consent and participant assent.
Key exclusion criteria (12 listed)
- Clinical or culture confirmed active TB;
- A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years;
- A documented history of a completing an adequate course of treatment for active TB or latent TB infection;
- Allergy to Isoniazid, Rifampin, or Rifapentine;
- Human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| Isoniazid；RifapentineAlso: Isoniazid I INH, Rifapentine RPT, 1RPT/INH 1HP1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation | Drug | Isoniazid/ Rifapentine 3 times a week |
Primary outcome
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
Time frame: 3 years
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
3 secondary outcomes
Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH
Time frame: up to 30 days after the last dose of study drug
Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH
Time frame: up to 30 days after the last dose of study drug
Percentage of participants who complete the treatment regimen
Time frame: Enrollment up to Month 1 (1RPT/INH)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 40326358Ruan QL, Yang QL, Ma CL, Lin MY, Huang XT, Mao YP, Gao JM, Li JJ, Zhang XN, You ZX, Zheng QQ, Ren YF, Liu XF, Shao LY, Zhang WH. Efficacy and safety of a novel short course rifapentine and isoniazid regimen for the preventive treatment of tuberculosis in Chinese silicosis patients: a pilot study (SCRIPT-TB). Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16.
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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.
Wenhong Zhang, MD，PhD contact
Wenhong Zhang, MD，PhD principal investigator
Huashan Hospital of Fudan University，Shanghai，China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoniazid；Rifapentine in people with Silicosis Tuberculosis, run by Huashan Hospital at 1 site 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 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Qiaoling Ruan, MD ((8621)52889999 ext. 8123, 10301010198@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900858, which also lists 1 linked publication.
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 5 Apr 2019.