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rifapentine

Phase 2

Pulmonary Tuberculosis | Small molecule | Infectious Disease |Sanofi|Last Updated: May 8, 2014

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment865
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00694629TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) TreatmentPHASE2 COMPLETED 865 — — Dec 1, 2008Dec 1, 2013May 8, 201429 United States, Brazil +4
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Study Endpoints
Primary Endpoints
The proportion of patients, by regimen, having negative sputum cultures at completion of eight weeks (40 doses) of treatment
completion of eight weeks (40 doses) of treatment
The proportion of patients, by regimen, who permanently discontinue the assigned study treatment for any reason during the first eight weeks
during the first eight weeks of treatment
Secondary Endpoints
time to culture-conversion
2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses)
proportion of patients with any Grade 3 or 4 adverse reactions
8 weeks
correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure
duration of TB treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORrifampin, isoniazid, pyrazinamide, ethambutol
2EXPERIMENTALrifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
3EXPERIMENTALrifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
4EXPERIMENTALrifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
Interventions
NameTypeDescription
rifampinDRUGtablet, 10 mg/kg, daily, 8 weeks
rifapentineDRUGtablet, 10 mg/kg, daily, 8 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: 1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. 2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment. 3...

Countries:United StatesBrazilCanadaSouth AfricaSpainUganda
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