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Pegylated interferon alfa-2b

Phase 3

Hepatitis C | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Apr 5, 2017

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00686517Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)PHASE3 COMPLETED 130 — — Dec 1, 2003Dec 1, 2010Apr 5, 2017 - —
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Study Endpoints
Primary Endpoints
Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
Evaluated at the end of 6 months

SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.

Secondary Endpoints
Virologic Response at the End of Treatment Follow-up (ETR)
At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PEG-IFN 24EXPERIMENTALpegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
PEG-IFN 12EXPERIMENTALpegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
PEG-IFN + RVB 12EXPERIMENTALpegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Interventions
NameTypeDescription
Pegylated interferon alfa-2bBIOLOGICAL1.5 ug/kg/week SC for 12 or 24 weeks
RibavirinDRUGRibavirin at the dose of 10.6 mg/kg/day for 12 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed with acute hepatitis C virus (HCV). * Normal and Elevated serum alanine transferase (ALT) levels * Positive serum HCV-RNA. * Aged between 18 and 65 years. * Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour per...

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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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