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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

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials4
Total Enrollment256

FDA Designations

No designations recorded

Clinical trial landscape

MP-424, PEG-IFN-a-2b, RBV · 4 trials · 1 indication

Phase 3 2Phase 2 1Phase 1 1
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 TherapyHepatitis C
COMPLETED32 Analytics
NCT00780416Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis CHepatitis C
COMPLETED189 Analytics
PHASE3COMPLETED
Efficacy 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 Therapy
Hepatitis CUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Hepatitis CUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range20 Years to 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
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about MP-424, PEG-IFN-a-2b, RBV

What is MP-424 used for?

MP-424 is an investigational small molecule being developed for the treatment of Hepatitis C and Chronic Hepatitis C. It is being studied in combination with peginterferon alfa-2b and ribavirin in patients with chronic Hepatitis C who have relapsed after prior interferon-based therapy.

Who makes MP-424?

MP-424 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company has conducted clinical trials of MP-424 in Japan for the treatment of Hepatitis C.

What phase is MP-424 in?

MP-424 is in Phase 3 clinical development. A Phase 3 trial, NCT00780910, has been completed, evaluating the efficacy and safety of MP-424 in combination with peginterferon alfa-2b and ribavirin in patients with chronic Hepatitis C who relapsed after previous interferon-based therapy.

What clinical trials is MP-424 in?

MP-424 has been studied in four completed clinical trials in Japan. These include NCT00591214 (Phase 1 safety and pharmacokinetics), NCT00621296 (Phase 2 safety and efficacy), NCT00630058 (Phase 1 combination study), and NCT00780910 (Phase 3 efficacy and safety study). All trials enrolled adult patients with Hepatitis C.

Is MP-424 FDA approved?

MP-424 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development. The available data shows completed Phase 1, Phase 2, and Phase 3 trials, but no approval status has been reported.