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2 DAA

Phase 3

HCV | Small molecule | Infectious Disease |AbbVie Inc.|Last Updated: Jul 30, 2021

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02247401Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in EgyptPHASE3 COMPLETED 160Nov 4, 2014Aug 1, 2016Jul 30, 2021 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
12 weeks after last dose

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug.

Number of Participants With Adverse Events
Screening until 30 days after last dose

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Secondary Endpoints
Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
Up to 12 or 24 weeks after first dose
Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
Up to 12 weeks after first dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AACTIVE_COMPARATORABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
Arm BACTIVE_COMPARATORABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Arm CACTIVE_COMPARATORABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Interventions
NameTypeDescription
2 DAADRUGABT-450/r/ABT-267 tablets
RBVDRUGRibavirin tablets
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Chronic hepatitis C, genotype 4-infection (hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] level greater than 1,000 IU/mL at Screening) * Subjects must meet one of the following: * Treatment-naive: Subject has never received antiviral treatment for HCV infection OR * T...

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