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Viramidine

Phase 3

Chronic Hepatitis C | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Jun 22, 2012

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,800
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00093093Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment NaivePHASE3 COMPLETED 900Jun 1, 2004May 1, 2006Jun 22, 2012100 United States, Argentina +10
NCT00230958Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-NaivePHASE3 COMPLETED 900Dec 1, 2003Jan 1, 2006Jun 22, 2012 -
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Study Endpoints
Primary Endpoints
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
- Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
Secondary Endpoints
- Efficacy: Undetectable plasma HCV RNA at treatment week 24
- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
- Safety: Monitoring of adverse events
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ViramidineDRUG -
RibavirinDRUG -
pegylated interferon alfa-2aDRUG -
pegylated interferon alfa-2bDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites100

Inclusion Criteria: * Treatment-naive patients with compensated chronic hepatitis C. * HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria: * Severe neuropsychiatric diso...

Countries:United StatesArgentinaAustraliaCanadaFranceIsraelItalyPolandPuerto RicoRussiaSpainUnited Kingdom
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