Pulmonary TuberculosisPhase 4NCT00298870
Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
A Phase 4 study testing Isoniazid and isoniazed in people with Pulmonary Tuberculosis, run by Osaka University at 4 sites in Japan.
Trial summary
The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Isoniazid and isoniazed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 4 sitesJapan
- Study dates
- Jun 2005to not given
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed pulmonary tuberculosis patients
- Informed consent including pharmacogenomic analysis
Who cannot join
- Abnormal liver and kidney function test before treatment
- Long-term use of steroids and/or immunodepressants
- Inadequate clinical conditions
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, 583-8588
Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch
Neyagawa, Osaka, 572-0801
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai, Osaka, 591-8555
National Hospital Organization Toneyama
Toyonaka, Osaka, 560-8552
About this study
The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Isoniazid, isoniazed
- Keywords
- pulmonary tuberculosis, isoniazid, arylamine N-acetyltransferase 2, pharmacogenomics, genetic polymorphisms, individualized medicine, drug-induced hepatotoxity
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively
isoniazedDrug
Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all
| Study group | Role | What they receive |
|---|---|---|
| PGx-treatment | Experimental | NAT2 genotype-guided treatment with stratified isoniazid dose (approx. 7.5 mg/kg b.w., patients homozygous for NAT2*4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2*4: intermediate acetylators; 2.5 mg/kg, patientes without NAT2*4: slow acetylators) Receives: Drug: Isoniazid |
| STD-treatment | Active comparator | Treatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.) Receives: Drug: isoniazed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
- the incidences of drug-induced liver injury associated with INH that occurred within 8 weeks of the treatments, and 2) the incidence of early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week
Secondary outcomes (1)
Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startJun 2005
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 Pulmonary TuberculosisStudies 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Investigators
- Junichi Azuma, MD, Study chair, Graduate School of Pharmaceutical Sciences, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298870
- Sponsor's protocol ID
- PG-MRT-TB-01
- Status last verified
- May 2011
- First submitted
- 2 Mar 2006
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Azuma J, Ohno M, Kubota R, Yokota S, Nagai T, Tsuyuguchi K, Okuda Y, Takashima T, Kamimura S, Fujio Y, Kawase I; Pharmacogenetics-based tuberculosis therapy research group. NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: a randomized controlled trial for pharmacogenetics-based therapy. Eur J Clin Pharmacol. 2013 May;69(5):1091-101. doi: 10.1007/s00228-012-1429-9. Epub 2012 Nov 14.
PubMed 23150149
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
- ClinicalTrials.gov ID
- NCT00298870
- Acronym / sponsor ID
- PG-MRT-TB-01
- Conditions
- Pulmonary Tuberculosis
- Keywords
- pulmonary tuberculosis, isoniazid, arylamine N-acetyltransferase 2, pharmacogenomics, genetic polymorphisms, individualized medicine, drug-induced hepatotoxity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- Jun 2005
- First posted
- 3 Mar 2006 (estimated)
- 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 this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGx-treatment | Experimental | Drug: IsoniazidNAT2 genotype-guided treatment with stratified isoniazid dose (approx. 7.5 mg/kg b.w., patients homozygous for NAT2*4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2*4: intermediate acetylators; 2.5 mg/kg, patientes without NAT2*4: slow acetylators) |
| STD-treatment | Active comparator | Drug: isoniazedTreatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed pulmonary tuberculosis patients
- Informed consent including pharmacogenomic analysis
Key exclusion criteria (3 listed)
- Abnormal liver and kidney function test before treatment
- Long-term use of steroids and/or immunodepressants
- Inadequate clinical conditions
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 |
|---|---|---|
| IsoniazidModified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively | Drug | PGx-treatment |
| isoniazedConventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all | Drug | STD-treatment |
Primary outcome
The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
1) the incidences of drug-induced liver injury associated with INH that occurred within 8 weeks of the treatments, and 2) the incidence of early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week
1 secondary outcome
Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
- Derived from this study: PubMed 23150149Azuma J, Ohno M, Kubota R, Yokota S, Nagai T, Tsuyuguchi K, Okuda Y, Takashima T, Kamimura S, Fujio Y, Kawase I; Pharmacogenetics-based tuberculosis therapy research group. NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: a randomized controlled trial for pharmacogenetics-based therapy. Eur J Clin Pharmacol. 2013 May;69(5):1091-101. doi: 10.1007/s00228-012-1429-9. Epub 2012 Nov 14.
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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.
Junichi Azuma, MD study chair
Graduate School of Pharmaceutical Sciences, Osaka University
4 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 Isoniazid and isoniazed in people with Pulmonary Tuberculosis, run by Osaka University at 4 sites in Japan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism. 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 NCT00298870, 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 18 Oct 2012.