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Rifampicin in higher doses

Phase 2

Tuberculosis | Small molecule | Infectious Disease |Sanofi|Last Updated: Sep 9, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00760149Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary TuberculosisPHASE2 COMPLETED 150 — — Jul 1, 2010Sep 1, 2013Sep 9, 20131 Tanzania
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol
Steady state, week 6
Secondary Endpoints
Occurrence of adverse events
baseline, week 1, 2, 4, 6, 8, 10, 12
Bacteriological response of Mycobacterium tuberculosis
Almost daily during first 8 weeks
Compare accuracy of surrogate markers (SSCC, mRNA, cytokines) with standard two-month sputum conversion marker
Almost daily during first 8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR50 patients, treated with the standard anti-TB regimen, including rifampicin (600 mg), isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 2 placebo tablets resembling rifampicin 300 mg.
2ACTIVE_COMPARATOR50 patients, treated with rifampicin (900 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 1 placebo tablet resembling rifampicin 300 mg.
3ACTIVE_COMPARATOR50 patients, treated with rifampicin (1200 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment.
Interventions
NameTypeDescription
Rifampicin in higher dosesDRUGRifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant has a newly diagnosed pulmonary tuberculosis, confirmed by a positive smear of at least two sputum specimens with ZN staining. * Participant is willing to be tested for HIV. * Participant is at least 18, but not more than 65 years of age at the day of the first dos...

Countries:Tanzania
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Competitive Landscape -Tuberculosis 7 trials
CompanyTickerTrialsLead PhaseDrugs
Viatris, Inc.VTRS1PHASE3Bedaquiline
Johnson & JohnsonJNJ1PHASE2Bedaquiline, Background Regimen
BioNTech SE Sponsored ADRBNTX1PHASE1BNT164a1, BNT164b1
Harvard Bioscience, Inc.HBIO1 — Bdq, Lzd, Lfx, Dlm, Cfz
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