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ACH-0143102

Phase 1

Chronic Hepatitis C Infection | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Aug 29, 2023

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01700179Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b ParticipantsPHASE1 COMPLETED 8Sep 1, 2012Sep 1, 2013Aug 29, 2023 -
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Study Endpoints
Primary Endpoints
Sustained Virologic Response At 12 Weeks (SVR12)
12 weeks following the last dose

To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACH-0143102 plus ribavirin dailyEXPERIMENTALACH-0143102 loading dose (225 milligrams \[mg\]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Interventions
NameTypeDescription
ACH-0143102DRUG -
RibavirinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males and females aged 18 years and older. * Clinical diagnosis of hepatitis C with GT1b. * Chronic hepatitis C treatment-naive participants. * Interleukin 28B genotype CC. * HCV ribonucleic acid \> 10,000 international units/milliliter at screening. * Female participants must...

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