Tuberculosis Clinical Trial
Official title:
Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months for Tuberculosis Preventive Treatment: A Randomized Controlled Study in China
NCT number | NCT02430259 |
Other study ID # | 81373064 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | June 2018 |
Verified date | June 2020 |
Source | Huashan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, the
three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now
recommended by WHO for its non-inferiority, safety and convenience compared with 6~9 months
regimen of daily isoniazid monotherapy or 3~4 months daily rifampicin monotherapy. And the
treatment completion rate is higher compared with daily regimen. However, relevant study is
lacking in China where the TB burden is high with the incidence rate of 70/100, 000. And the
provision of chemoprophylaxis is not recommended in China currently.
Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an
open-label, randomized, Phase III clinical trial to evaluate the effectiveness and
tolerability of the 3RPT/INH to prevent tuberculosis (TB) compared with those who do not
receive preventive treatment among silicotic patients.
Status | Completed |
Enrollment | 566 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
China | Wenling No.1 People's Hospital, Zhejiang | Taizhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants | 3 years | ||
Secondary | Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 3RPT/INH | up to 30 days after the last dose of study drug | ||
Secondary | Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 3RPT/INH | up to 30 days after the last dose of study drug | ||
Secondary | Percentage of participants who complete the treatment regimen | Enrollment up to Month 3 (3RPT/INH) | ||
Secondary | The proportion of rifampicin and/or isoniazid resistance of M. tuberculosis isolates in patients who develop TB in preventive treatment group. | 3 years | ||
Secondary | Measure the quantitative and qualitative changes of the results of QuantiFERON Gold In-Tube before and after preventive treatment. | Enrollment up to 3 months after preventive treatment |
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