Recent Updates
Recently added Catalysts

MP-424, PEG-IFN-a-2b, RBV

Phase 3

Hepatitis C | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Jan 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials4
Total Enrollment256
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00781274Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based TherapyPHASE3 COMPLETED 32Dec 1, 2008Jul 1, 2010Jan 6, 20261 Japan
NCT00780416Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis CPHASE3 COMPLETED 189Nov 1, 2008Aug 1, 2010Jan 6, 20261 Japan
NCT00621296Safety and Efficacy of MP-424 to Treat Chronic Hepatitis CPHASE2 COMPLETED 15Jan 1, 2008Feb 1, 2009Jan 6, 20261 Japan
NCT00630058A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis CPHASE1 COMPLETED 20Apr 1, 2008Mar 1, 2009Jan 6, 20261 Japan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
After 24 weeks of follow-up
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration
24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Tmax (Time of Maximum Concentration in Plasma) of MP-424
Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

T1/2(Time of Half-Life) of MP-424
Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Secondary Endpoints
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
37 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MP-424EXPERIMENTAL -
TRV/PEG/RBVEXPERIMENTAL -
PEG/RBVACTIVE_COMPARATOR -
Group A (MP-424 High)EXPERIMENTAL -
Group B (MP-424 Low)EXPERIMENTAL -
Interventions
NameTypeDescription
MP-424DRUG750 mg every 8 hours for 12 weeks
RibavirinDRUG600 - 1000 mg/day based on body weight for 24 weeks
Peginterferon Alfa-2bDRUG1.5 mcg/kg/week for 24 weeks
MP-424 (Telaprevir)DRUGThree tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
MP-424(H), PEG-IFN-a-2b, RBVDRUGMP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
MP-424 (L), PEG-IFN-a-2b, RBVDRUGMP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Genotype 1, chronic hepatitis C * Non-responders (patient who did not respond to previous treatment) * Able and willing to follow contraception requirements Exclusion Criteria: * Cirrhosis of the liver or hepatic failure * Hepatitis B surface antigen-positive or HIV antibodi...

Countries:Japan
Unlock Eligibility Criteria
Competitive Landscape -Hepatitis C 11 trials