TuberculosisPhase 4NCT02689089
Taima TB: 3HP Study
A Phase 4 study testing 3HP in people with Tuberculosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study is to compare the proportion of people who complete directly observed prophylactic treatment (DOPT) using the new 3HP regimen to the… Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- 3HP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2016to 15 Aug 2019
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-nursing females between the ages of 2-65 years
- LTBI diagnosis as per Canadian TB Standards using either the Tuberculin Skin Test (TST) or the Interferon Gamma Release Assay (IGRA)
- Children 2-5 years with negative TSTs who have been in close contact with a case of active TB disease recently
- Able and willing to provide fully informed consent or parent/guardian able to provide consent
Who cannot join
- Suspected or confirmed active TB disease
- Known allergies to any of the study medications by participant self-report
- Female participants of childbearing potential who:
- have a positive pregnancy test at screening, or
- are not willing to use a reliable method of barrier contraception during the study, or
- are breastfeeding
Show all 16Show fewer
- Unable/unwilling to substitute medications with drug interactions with 3HP, including :
- hormonal contraception
- HIV infected participants who are on anti-retroviral drugs
- other drugs that interact with 3HP (see Table 1)
- Known contact with an INH or rifampin resistant case
- Weight < 10 kg
- Evidence of possible liver damage defined by an aspartate transaminase (AST) level that is more than 3x the upper limit of normal in an asymptomatic patient
- Porphyria reported by patient
- Inability to adhere to protocol.
- Patients may be excluded from the study for other reasons, at the investigator's discretion with detailed documentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Completion Rates of a New 12 Dose Treatment (3 Month) Compared to the Standard Treatment for Latent TB Infection Treatment
This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study is to compare the proportion of people who complete directly observed prophylactic treatment (DOPT) using the new 3HP regimen to the current standard of 9 months INH.
Read the detailed description
The treatment of latent tuberculosis infection (LTBI) is a vital component of the overall strategy to reduce TB in a population. Treatment prevents ongoing transmission in communities by preventing the development of active TB disease. The current international standard for the treatment of LTBI is 9 months of Isoniazid (INH). Adherence to this lengthy regimen is one of the greatest impediments to treatment. A recent multi-centered, multi-national randomized control non inferiority trial with approximately 4,000 patients per arm demonstrated that Rifapentine and INH (3HP) given once weekly for a total of 12 doses was as effective as 9 months (252 doses) of daily INH treatment for LTBI.(1) These findings were also replicated in the pediatric population through a pediatric cohort (n=905 eligible participants) nested within the multi-centered international randomized controlled trial with children between ages 2-17 treated with 3HP compared to the INH standard for LTBI.(2) The efficacy and safety of this new regimen have been established. Rifapentine was approved by the United States Food and Drug Administration (FDA) in December of 2014 for the treatment of LTBI but is not yet approved in Canada. The shortened treatment course could increase the number of people who complete LTBI treatment which could lead to a decrease in active TB cases.
- Conditions
- Tuberculosis
- Being tested
- 3HP
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3HPDrug
Also called rifapentine, Priftin
An interrupted time series study design will be used to determine if the introduction of the 3HP regimen will result in more people completing LTBI treatment compared to the standard of 9 months INH twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| 3HP | Other | The interrupted time series design aims to collect data at multiple time points before (standard regimen) and after the introduction of the new 3HP regimen (interruption) to detect if a significant increase in the number of completions has occurred with the new regimen Receives: Drug: 3HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of treatment
Participants who start and complete treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start28 Nov 2016
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Nunavut, Government of Canada
- Responsible party
- Sponsor
- Investigators
- Gonzalo G Alvarez, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689089
- Sponsor's protocol ID
- 20160044-01H
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Institutional approval would be required from research collaborators for the release of this data.
Publications
Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875.
PubMed 22150035Villarino ME, Scott NA, Weis SE, Weiner M, Conde MB, Jones B, Nachman S, Oliveira R, Moro RN, Shang N, Goldberg SV, Sterling TR; International Maternal Pediatric and Adolescents AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Treatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid. JAMA Pediatr. 2015 Mar;169(3):247-55. doi: 10.1001/jamapediatrics.2014.3158.
PubMed 25580725
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Completion Rates of a New 12 Dose Treatment (3 Month) Compared to the Standard Treatment for Latent TB Infection Treatment
- ClinicalTrials.gov ID
- NCT02689089
- Acronym / sponsor ID
- 20160044-01H
- Conditions
- Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Government of Nunavut, Government of Canada
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 23 Feb 2016 (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.
This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study is to compare the proportion of people who complete directly observed prophylactic treatment (DOPT) using the new 3HP regimen to the current standard of 9 months INH.
Detailed description
The treatment of latent tuberculosis infection (LTBI) is a vital component of the overall strategy to reduce TB in a population. Treatment prevents ongoing transmission in communities by preventing the development of active TB disease. The current international standard for the treatment of LTBI is 9 months of Isoniazid (INH). Adherence to this lengthy regimen is one of the greatest impediments to treatment. A recent multi-centered, multi-national randomized control non inferiority trial with approximately 4,000 patients per arm demonstrated that Rifapentine and INH (3HP) given once weekly for a total of 12 doses was as effective as 9 months (252 doses) of daily INH treatment for LTBI.(1) These findings were also replicated in the pediatric population through a pediatric cohort (n=905 eligible participants) nested within the multi-centered international randomized controlled trial with children between ages 2-17 treated with 3HP compared to the INH standard for LTBI.(2) The efficacy and safety of this new regimen have been established. Rifapentine was approved by the United States Food and Drug Administration (FDA) in December of 2014 for the treatment of LTBI but is not yet approved in Canada. The shortened treatment course could increase the number of people who complete LTBI treatment which could lead to a decrease in active TB cases.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3HP | Other | Drug: 3HPThe interrupted time series design aims to collect data at multiple time points before (standard regimen) and after the introduction of the new 3HP regimen (interruption) to detect if a significant increase in the number of completions has occurred with the new regimen |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Males or non-pregnant, non-nursing females between the ages of 2-65 years
- LTBI diagnosis as per Canadian TB Standards using either the Tuberculin Skin Test (TST) or the Interferon Gamma Release Assay (IGRA)
- Children 2-5 years with negative TSTs who have been in close contact with a case of active TB disease recently
- Able and willing to provide fully informed consent or parent/guardian able to provide consent
Key exclusion criteria (16 listed)
- Suspected or confirmed active TB disease
- Known allergies to any of the study medications by participant self-report
- Female participants of childbearing potential who:
- Unable/unwilling to substitute medications with drug interactions with 3HP, including :
- Known contact with an INH or rifampin resistant case
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 |
|---|---|---|
| 3HPAlso: rifapentine, PriftinAn interrupted time series study design will be used to determine if the introduction of the 3HP regimen will result in more people completing LTBI treatment compared to the standard of 9 months INH twice weekly. | Drug | 3HP |
Primary outcome
Completion of treatment
Time frame: 3 months
Participants who start and complete treatment
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 24 Mar 2020.
- Background: PubMed 22150035Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875.
- Background: PubMed 25580725Villarino ME, Scott NA, Weis SE, Weiner M, Conde MB, Jones B, Nachman S, Oliveira R, Moro RN, Shang N, Goldberg SV, Sterling TR; International Maternal Pediatric and Adolescents AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Treatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid. JAMA Pediatr. 2015 Mar;169(3):247-55. doi: 10.1001/jamapediatrics.2014.3158.
- Individual participant dataSharing planned: No. Institutional approval would be required from research collaborators for the release of this data.
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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.
Gonzalo G Alvarez, MD principal investigator
Ottawa Hospital Research Institute
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 3HP in people with Tuberculosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 16 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 24 Mar 2020. 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 Canada. 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?
Completion of treatment (time frame: 3 months). 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 NCT02689089, which also lists 2 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 24 Mar 2020.