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peginterferon alfa-2a

Phase 2

Hepatitis C | Monoclonal antibody | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Mar 10, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

peginterferon alfa-2a · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00983853Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIVHepatitis C
COMPLETED62 Analytics
PHASE2COMPLETED
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
12 weeks after first dose of study drug
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)
Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)
Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Study visits throughout part B

Secondary Endpoints

Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
4 and 12 weeks after the first dose of study drug
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
12 weeks after last dose of study drug
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
through 12 weeks after first dose of study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part AEXPERIMENTALThe dose of ribavirin used (fixed versus weight-based) is region dependent
Part BEXPERIMENTALThe dose of ribavirin used (fixed versus weight-based) is region dependent

Interventions

NameTypeDescription
telaprevir or matching placeboDRUGTablet, Oral, 750 mg, q8h, 12 weeks
peginterferon alfa-2aBIOLOGICALSubcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin (fixed dose)DRUGTablet, Oral, 800 mg, b.i.d., 48 weeks
ribavirin (weight-based dose)DRUGTablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
VCH-222 or matching placeboDRUGcapsule, oral, 4 doses once daily or twice daily, 3 days
ribavirinDRUGtablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Chronic, genotype 1, hepatitis C with detectable HCV RNA * HIV-1 infection for \>6 months * Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis) Exclusion Criteria: * Previous tr...

Countries:United StatesFranceGermanySpainArgentinaCanadaPuerto Rico
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about peginterferon alfa-2a

What is peginterferon alfa-2a used for?

Peginterferon alfa-2a is used for the treatment of Hepatitis C. It is being studied in combination with other antiviral agents, such as telaprevir and ribavirin, particularly in patients co-infected with HIV. The drug is currently in Phase 2 clinical development for this indication.

Who makes peginterferon alfa-2a?

Peginterferon alfa-2a is being developed by Vertex Pharmaceuticals Incorporated, which is publicly traded under the ticker VRTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating Hepatitis C.

What phase is peginterferon alfa-2a in?

Peginterferon alfa-2a is in Phase 2 clinical development for Hepatitis C. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in combination with other agents to assess its safety and efficacy.

What clinical trials is peginterferon alfa-2a in?

Peginterferon alfa-2a has been studied in two completed clinical trials. One trial (NCT00911963) evaluated the pharmacokinetics of multiple ascending doses of VCH-222 in subjects with chronic Hepatitis C. Another trial (NCT00983853) assessed the safety and efficacy of telaprevir in combination with peginterferon alfa-2a and ribavirin in subjects co-infected with Hepatitis C and HIV.

Is peginterferon alfa-2a the same as VCH-222?

No, peginterferon alfa-2a is not the same as VCH-222. In the clinical trial NCT00911963, VCH-222 is the investigational drug being studied, while peginterferon alfa-2a is used as a background therapy. The two are distinct agents with different mechanisms of action.