Tuberculosis (TB)Phase 4NCT06484530
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
A Phase 4 study testing N acetyl cysteine in people with Tuberculosis (TB) and Isoniazid Toxicity, run by Mahidol University at 1 site in Thailand.
Trial summary
Tuberculosis (TB) remains a significant public health concern in Thailand and globally, especially in tropical regions, with pulmonary TB being predominant. Besides affecting the lungs, TB can also impact extrapulmonary organs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tuberculosis (TB), Isoniazid Toxicity, Rifampicin Toxicity
- What is being tested?
- N acetyl cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteThailand
- Study dates
- 12 Mar 2024to 18 Sep 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 - 80 years old.
- Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary).
- Received standard anti-tuberculosis medication according to standard regimens (2HRZE/4HR, 2HRE/7HR).
- Willing to participate in the research
Who cannot join
- Infected with HIV.
- Severe liver dysfunction classified as Child-Pugh B or C.
- Chronic untreated liver diseases such as hepatitis B or C, alcoholic liver disease.
- Abnormal liver function tests including AST > 1.5 times the upper limit of normal (48 U/L), ALT > 1.5 times the upper limit of normal (55 U/L), ALP > upper limit of normal (110 U/L), Total bilirubin > upper limit of normal (1.2 mg/dL).
- Diagnosed with cancer.
- History of allergy to N-acetylcysteine (NAC).
- Pregnant or breastfeeding.
- Severe comorbidities such as CKD stage 4-5, chronic heart failure, severe pulmonary diseases (COPD, bronchiectasis).
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Pongpot Namasae, MD, +66954408520, shy.pongpot@gmail.com
Supot Nimanong, MD, +66819134336, supotgi@gmail.com
About this study
Official title: Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis: A Randomized Controlled Trial
Tuberculosis (TB) remains a significant public health concern in Thailand and globally, especially in tropical regions, with pulmonary TB being predominant. Besides affecting the lungs, TB can also impact extrapulmonary organs. Standard TB treatment involves a combination of drugs administered for at least 6 months, but it can cause adverse effects such as hepatitis. Hepatotoxicity, occurring in 20-60% of patients, is commonly linked to isoniazid, rifampicin, and pyrazinamide. Slow acetylators of the NAT2 gene are particularly susceptible. Previous research suggests N-acetylcysteine (NAC) may mitigate hepatotoxicity, especially among slow acetylators. A recent study by Kittichai Samaithongcharoen and team showed that NAC reduced hepatotoxicity incidence significantly among slow acetylators. This underscores the potential of NAC in preventing drug-induced hepatotoxicity in TB treatment, warranting further investigation against standard treatment protocols.
Read the detailed description
Tuberculosis (TB) is a significant public health problem in Thailand and globally, especially in hot climates. TB infection is commonly found in the lungs, but it can also affect other important organs such as lymph nodes, pleura, abdomen, musculoskeletal system, urinary tract, and nervous system. The current standard treatment regimen for TB consists of a combination of drugs (isoniazid, rifampicin, pyrazinamide, and ethambutol), used for new TB patients who have not been treated before or have received less than 1 month of treatment. A major challenge in TB treatment is that patients must take multiple drugs continuously for at least 6 months, with common side effects including skin rash, dizziness, hepatitis, nausea, vomiting, and abdominal pain, often occurring within the first 2 months of treatment. Hepatotoxicity from anti-TB drugs is a common side effect, occurring in 20-60% of patients, mostly within the first 2 weeks to 2 months of starting treatment. Isoniazid, rifampicin, and pyrazinamide are the drugs most commonly associated with hepatotoxicity, typically causing hepatocellular injury of varying severity. NAT2 slow acetylator phenotype individuals are at higher risk. Studies in Thailand have found a high prevalence (25-30%) of NAT2 slow acetylators among Thai people. Preventing hepatotoxicity from anti-TB drugs is crucial, especially for high-risk patients, although clear guidelines are lacking. Previous studies have shown that administering N-acetylcysteine (NAC), an antioxidant, can reduce hepatotoxicity, particularly in slow acetylators. A recent controlled study by Kittichai Samaithongcharoen and colleagues demonstrated the significant efficacy of NAC in preventing hepatotoxicity in slow acetylators receiving standard TB treatment, with no cases of hepatotoxicity compared to a 50% incidence in the control group. Further research is needed to explore the effectiveness of NAC administration for preventing hepatotoxicity from anti-TB drugs, based on NAT2 genotype testing, compared to current standard TB treatment protocols.
- Conditions
- Tuberculosis (TB), Isoniazid Toxicity, Rifampicin Toxicity, Pyrazinamide Adverse Reaction, Ethambutol Toxicity, NAT2 Slow Acetylator Status
- Being tested
- N acetyl cysteine
- Keywords
- Tuberculosis (TB), Isoniazid Toxicity, Rifampicin Toxicity, Pyrazinamide Adverse Reaction, Ethambutol Toxicity, NAT2 Slow Acetylator Status, NAT2 Rapid Acetylator Status, NAT2 Polymorphism, N-Acetylcysteine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N acetyl cysteineDrug
Also called Standard anti TB drug regimen
1,200 mg/day for 8 weeks in NAT2 gene testing group and NAT2 gene phenotype is identified as slow acetylator.
| Study group | Role | What they receive |
|---|---|---|
| NAT2 gene testing group | Experimental | Tuberculosis patients will undergo NAT2 gene testing before starting anti-tuberculosis medication. If the NAT2 gene phenotype is identified as slow acetylator, the patient will receive NAC medication at a dose of 600 mg twice daily for 8 weeks in addition to anti-tuberculosis medication. If the NAT2 gene phenotype is identified as rapid or intermediate acetylator, the patient will receive only anti-tuberculosis medication. Receives: Drug: N acetyl cysteine |
| Non NAT2 gene testing | No intervention | Tuberculosis patients will receive standard anti-tuberculosis medication without NAT2 gene testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hepatitis at 8 weeks
To study the efficacy of administering N-acetylcysteine (NAC) to prevent drug-induced hepatitis at 8 weeks from anti-tuberculosis medication using gene-guided therapy compared to conventional therapy.
Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels or Total bilirubin(TB) more than 2.5 milligrams per decilitre (mg/dL)
Measured: 8 weeks
Secondary outcomes (1)
Prevalence of hepatitis at 2 weeks
To study the efficacy of administering N-acetylcysteine (NAC) to prevent drug-induced hepatitis at 2 weeks from anti-tuberculosis medication using gene-guided therapy compared to conventional therapy.
Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels or Total bilirubin(TB) more than 2.5 milligrams per decilitre (mg/dL)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start12 Mar 2024
- Primary completion18 Sep 2024 (estimated)
- Study completion18 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with tuberculosis who meet the research criteria will be randomly assigned into 2 groups using a block of four method with a 1:1 ratio. Patients in group 1 will undergo NAT2 gene testing before starting anti-tuberculosis medication. If the NAT2 gene phenotype is identified as slow acetylator, the patient will receive NAC medication at a dose of 600 mg twice daily for 8 weeks in addition to anti-tuberculosis medication. If the NAT2 gene phenotype is identified as rapid or intermediate acetylator, the patient will receive only anti-tuberculosis medication. Patients in group 2 will receive standard anti-tuberculosis medication without NAT2 gene testing.All patients will undergo blood tests to monitor liver function, kidney function, and blood count at 2, 8 weeks, and 6 months after starting medication.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Watcharasak Chotiyaputta, Mahidol University
- Investigators
- Supot Nimanong, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484530
- Sponsor's protocol ID
- Si 708/2023
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palwatwichai A. Tuberculosis in Thailand. Respirology. 2001 Mar;6(1):65-70. doi: 10.1046/j.1440-1843.2001.00299.x.
PubMed 11264766Treatment of Tuberculosis: Guidelines. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138748/
PubMed 23741786Wiwatworapan T, Anantasetagoon T. Extra-pulmonary tuberculosis at a regional hospital in Thailand. Southeast Asian J Trop Med Public Health. 2008 May;39(3):521-5.
PubMed 18564694Bouazzi OE, Hammi S, Bourkadi JE, Tebaa A, Tanani DS, Soulaymani-Bencheikh R, Badrane N, Bengueddour R. First line anti-tuberculosis induced hepatotoxicity: incidence and risk factors. Pan Afr Med J. 2016 Nov 16;25:167. doi: 10.11604/pamj.2016.25.167.10060. eCollection 2016.
PubMed 28292129Anand AC, Seth AK, Paul M, Puri P. Risk Factors of Hepatotoxicity During Anti-tuberculosis Treatment. Med J Armed Forces India. 2006 Jan;62(1):45-9. doi: 10.1016/S0377-1237(06)80155-3. Epub 2011 Jul 21.
PubMed 27407844Gaude GS, Chaudhury A, Hattiholi J. Drug-induced hepatitis and the risk factors for liver injury in pulmonary tuberculosis patients. J Family Med Prim Care. 2015 Apr-Jun;4(2):238-43. doi: 10.4103/2249-4863.154661.
PubMed 25949974Ramappa V, Aithal GP. Hepatotoxicity Related to Anti-tuberculosis Drugs: Mechanisms and Management. J Clin Exp Hepatol. 2013 Mar;3(1):37-49. doi: 10.1016/j.jceh.2012.12.001. Epub 2012 Dec 20.
PubMed 25755470Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SH, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM; U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002 Dec 17;137(12):947-54. doi: 10.7326/0003-4819-137-12-200212170-00007.
PubMed 12484709Fountain FF, Tolley E, Chrisman CR, Self TH. Isoniazid hepatotoxicity associated with treatment of latent tuberculosis infection: a 7-year evaluation from a public health tuberculosis clinic. Chest. 2005 Jul;128(1):116-23. doi: 10.1378/chest.128.1.116.
PubMed 16002924Kopanoff DE, Snider DE Jr, Caras GJ. Isoniazid-related hepatitis: a U.S. Public Health Service cooperative surveillance study. Am Rev Respir Dis. 1978 Jun;117(6):991-1001. doi: 10.1164/arrd.1978.117.6.991.
PubMed 666111International Union Against Tuberculosis Committee on Prophylaxis. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: five years of follow-up in the IUAT trial. International Union Against Tuberculosis Committee on Prophylaxis. Bull World Health Organ. 1982;60(4):555-64.
PubMed 6754120Steele MA, Burk RF, DesPrez RM. Toxic hepatitis with isoniazid and rifampin. A meta-analysis. Chest. 1991 Feb;99(2):465-71. doi: 10.1378/chest.99.2.465. No abstract available.
PubMed 1824929Thongraung W, Sittidach M, Khwansuwan P, Sariyasuntorn K, Wongsampan S. Evaluation of the physicians' approach to the diagnosis and treatment of patients with antituberculosis drug-induced hepatotoxicity. J Eval Clin Pract. 2012 Dec;18(6):1119-25. doi: 10.1111/j.1365-2753.2011.01706.x. Epub 2011 Jun 22.
PubMed 21696520Huang YS, Chern HD, Su WJ, Wu JC, Lai SL, Yang SY, Chang FY, Lee SD. Polymorphism of the N-acetyltransferase 2 gene as a susceptibility risk factor for antituberculosis drug-induced hepatitis. Hepatology. 2002 Apr;35(4):883-9. doi: 10.1053/jhep.2002.32102.
PubMed 11915035Yang S, Hwang SJ, Park JY, Chung EK, Lee JI. Association of genetic polymorphisms of CYP2E1, NAT2, GST and SLCO1B1 with the risk of anti-tuberculosis drug-induced liver injury: a systematic review and meta-analysis. BMJ Open. 2019 Aug 1;9(8):e027940. doi: 10.1136/bmjopen-2018-027940.
PubMed 31375612
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06484530
- Acronym / sponsor ID
- Si 708/2023
- Conditions
- Tuberculosis (TB), Isoniazid Toxicity, Rifampicin Toxicity, Pyrazinamide Adverse Reaction, Ethambutol Toxicity, NAT2 Slow Acetylator Status
- Keywords
- Tuberculosis (TB), Isoniazid Toxicity, Rifampicin Toxicity, Pyrazinamide Adverse Reaction, Ethambutol Toxicity, NAT2 Slow Acetylator Status, NAT2 Rapid Acetylator Status, NAT2 Polymorphism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 18 Sep 2024 (estimated)
- Study completion
- 18 Sep 2024 (estimated)
- First posted
- 3 Jul 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.
Tuberculosis (TB) remains a significant public health concern in Thailand and globally, especially in tropical regions, with pulmonary TB being predominant. Besides affecting the lungs, TB can also impact extrapulmonary organs. Standard TB treatment involves a combination of drugs administered for at least 6 months, but it can cause adverse effects such as hepatitis. Hepatotoxicity, occurring in 20-60% of patients, is commonly linked to isoniazid, rifampicin, and pyrazinamide. Slow acetylators of the NAT2 gene are particularly susceptible. Previous research suggests N-acetylcysteine (NAC) may mitigate hepatotoxicity, especially among slow acetylators. A recent study by Kittichai Samaithongcharoen and team showed that NAC reduced hepatotoxicity incidence significantly among slow acetylators. This underscores the potential of NAC in preventing drug-induced hepatotoxicity in TB treatment, warranting further investigation against standard treatment protocols.
Detailed description
Tuberculosis (TB) is a significant public health problem in Thailand and globally, especially in hot climates. TB infection is commonly found in the lungs, but it can also affect other important organs such as lymph nodes, pleura, abdomen, musculoskeletal system, urinary tract, and nervous system. The current standard treatment regimen for TB consists of a combination of drugs (isoniazid, rifampicin, pyrazinamide, and ethambutol), used for new TB patients who have not been treated before or have received less than 1 month of treatment. A major challenge in TB treatment is that patients must take multiple drugs continuously for at least 6 months, with common side effects including skin rash, dizziness, hepatitis, nausea, vomiting, and abdominal pain, often occurring within the first 2 months of treatment. Hepatotoxicity from anti-TB drugs is a common side effect, occurring in 20-60% of patients, mostly within the first 2 weeks to 2 months of starting treatment. Isoniazid, rifampicin, and pyrazinamide are the drugs most commonly associated with hepatotoxicity, typically causing hepatocellular injury of varying severity. NAT2 slow acetylator phenotype individuals are at higher risk. Studies in Thailand have found a high prevalence (25-30%) of NAT2 slow acetylators among Thai people. Preventing hepatotoxicity from anti-TB drugs is crucial, especially for high-risk patients, although clear guidelines are lacking. Previous studies have shown that administering N-acetylcysteine (NAC), an antioxidant, can reduce hepatotoxicity, particularly in slow acetylators. A recent controlled study by Kittichai Samaithongcharoen and colleagues demonstrated the significant efficacy of NAC in preventing hepatotoxicity in slow acetylators receiving standard TB treatment, with no cases of hepatotoxicity compared to a 50% incidence in the control group. Further research is needed to explore the effectiveness of NAC administration for preventing hepatotoxicity from anti-TB drugs, based on NAT2 genotype testing, compared to current standard TB treatment protocols.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with tuberculosis who meet the research criteria will be randomly assigned into 2 groups using a block of four method with a 1:1 ratio. Patients in group 1 will undergo NAT2 gene testing before starting anti-tuberculosis medication. If the NAT2 gene phenotype is identified as slow acetylator, the patient will receive NAC medication at a dose of 600 mg twice daily for 8 weeks in addition to anti-tuberculosis medication. If the NAT2 gene phenotype is identified as rapid or intermediate acetylator, the patient will receive only anti-tuberculosis medication. Patients in group 2 will receive standard anti-tuberculosis medication without NAT2 gene testing.All patients will undergo blood tests to monitor liver function, kidney function, and blood count at 2, 8 weeks, and 6 months after starting medication.
| Arm | Type | Receives |
|---|---|---|
| NAT2 gene testing group | Experimental | Drug: N acetyl cysteineTuberculosis patients will undergo NAT2 gene testing before starting anti-tuberculosis medication. If the NAT2 gene phenotype is identified as slow acetylator, the patient will receive NAC medication at a dose of 600 mg twice daily for 8 weeks in addition to anti-tuberculosis medication. If the NAT2 gene phenotype is identified as rapid or intermediate acetylator, the patient will receive only anti-tuberculosis medication. |
| Non NAT2 gene testing | No intervention | –Tuberculosis patients will receive standard anti-tuberculosis medication without NAT2 gene testing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 - 80 years old.
- Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary).
- Received standard anti-tuberculosis medication according to standard regimens (2HRZE/4HR, 2HRE/7HR).
- Willing to participate in the research
Key exclusion criteria (8 listed)
- Infected with HIV.
- Severe liver dysfunction classified as Child-Pugh B or C.
- Chronic untreated liver diseases such as hepatitis B or C, alcoholic liver disease.
- Abnormal liver function tests including AST > 1.5 times the upper limit of normal (48 U/L), ALT > 1.5 times the upper limit of normal (55 U/L), ALP > upper limit of normal (110 U/L), Total bilirubin > upper limit of normal (1.2 mg/dL).
- Diagnosed with cancer.
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 |
|---|---|---|
| N acetyl cysteineAlso: Standard anti TB drug regimen1,200 mg/day for 8 weeks in NAT2 gene testing group and NAT2 gene phenotype is identified as slow acetylator. | Drug | NAT2 gene testing group |
Primary outcome
Prevalence of hepatitis at 8 weeks
Time frame: 8 weeks
To study the efficacy of administering N-acetylcysteine (NAC) to prevent drug-induced hepatitis at 8 weeks from anti-tuberculosis medication using gene-guided therapy compared to conventional therapy. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels or Total bilirubin(TB) more than 2.5 milligrams per decilitre (mg/dL)
1 secondary outcome
Prevalence of hepatitis at 2 weeks
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 11264766Palwatwichai A. Tuberculosis in Thailand. Respirology. 2001 Mar;6(1):65-70. doi: 10.1046/j.1440-1843.2001.00299.x.
- Background: PubMed 23741786Treatment of Tuberculosis: Guidelines. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138748/
- Background: PubMed 18564694Wiwatworapan T, Anantasetagoon T. Extra-pulmonary tuberculosis at a regional hospital in Thailand. Southeast Asian J Trop Med Public Health. 2008 May;39(3):521-5.
- Background: PubMed 28292129Bouazzi OE, Hammi S, Bourkadi JE, Tebaa A, Tanani DS, Soulaymani-Bencheikh R, Badrane N, Bengueddour R. First line anti-tuberculosis induced hepatotoxicity: incidence and risk factors. Pan Afr Med J. 2016 Nov 16;25:167. doi: 10.11604/pamj.2016.25.167.10060. eCollection 2016.
- Background: PubMed 27407844Anand AC, Seth AK, Paul M, Puri P. Risk Factors of Hepatotoxicity During Anti-tuberculosis Treatment. Med J Armed Forces India. 2006 Jan;62(1):45-9. doi: 10.1016/S0377-1237(06)80155-3. Epub 2011 Jul 21.
- Background: PubMed 25949974Gaude GS, Chaudhury A, Hattiholi J. Drug-induced hepatitis and the risk factors for liver injury in pulmonary tuberculosis patients. J Family Med Prim Care. 2015 Apr-Jun;4(2):238-43. doi: 10.4103/2249-4863.154661.
- Background: PubMed 25755470Ramappa V, Aithal GP. Hepatotoxicity Related to Anti-tuberculosis Drugs: Mechanisms and Management. J Clin Exp Hepatol. 2013 Mar;3(1):37-49. doi: 10.1016/j.jceh.2012.12.001. Epub 2012 Dec 20.
- Background: PubMed 12484709Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SH, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM; U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002 Dec 17;137(12):947-54. doi: 10.7326/0003-4819-137-12-200212170-00007.
- Background: PubMed 16002924Fountain FF, Tolley E, Chrisman CR, Self TH. Isoniazid hepatotoxicity associated with treatment of latent tuberculosis infection: a 7-year evaluation from a public health tuberculosis clinic. Chest. 2005 Jul;128(1):116-23. doi: 10.1378/chest.128.1.116.
- Background: PubMed 666111Kopanoff DE, Snider DE Jr, Caras GJ. Isoniazid-related hepatitis: a U.S. Public Health Service cooperative surveillance study. Am Rev Respir Dis. 1978 Jun;117(6):991-1001. doi: 10.1164/arrd.1978.117.6.991.
- Background: PubMed 6754120International Union Against Tuberculosis Committee on Prophylaxis. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: five years of follow-up in the IUAT trial. International Union Against Tuberculosis Committee on Prophylaxis. Bull World Health Organ. 1982;60(4):555-64.
- Background: PubMed 1824929Steele MA, Burk RF, DesPrez RM. Toxic hepatitis with isoniazid and rifampin. A meta-analysis. Chest. 1991 Feb;99(2):465-71. doi: 10.1378/chest.99.2.465. No abstract available.
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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.
Supot Nimanong principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N acetyl cysteine in people with Tuberculosis (TB) and Isoniazid Toxicity, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 8 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 3 Jul 2024. 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 Thailand. 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 Pongpot Namasae (66954408520, shy.pongpot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hepatitis at 8 weeks (time frame: 8 weeks). 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 NCT06484530, which also lists 15 linked publications.
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 3 Jul 2024.