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Peg-Intron

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Feb 11, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment246

FDA Designations

No designations recorded

Clinical trial landscape

Peg-Intron · 1 trial · 1 indication

Phase 2 1
NCT00367887A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder SubjectsHepatitis C
COMPLETED246 Analytics
PHASE2COMPLETED
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Hepatitis C Virus (HCV) RNA concentrations in the blood.
72 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Peg-IntronDRUGSC injection, weight based dosing, weekly, 48 weeks
REBETOLDRUGCapsules, weight based dosing, Q12 hrs daily, 48weeks
HCV 796DRUGCapsules, 500 mg, Q 12 hrs. daily, 48 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Infection with HCV genotype 1. * HCV- infected subjects naive to treatment. * HCV-infected non-responder subjects. Exclusion Criteria: * Women who are pregnant or breastfeeding. * ALT \>/ or = 5X the upper limit of normal. * AST \>/ or = 5X the upper limit of normal.

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

Frequently asked questions about Peg-Intron

What is Peg-Intron used for in Hepatitis C?

Peg-Intron is an investigational small molecule being studied for the treatment of Hepatitis C. It is currently in Phase 2 clinical development. The drug is being evaluated in patients with Hepatitis C, as part of a clinical trial program assessing its safety and clinical activity.

Who makes Peg-Intron?

Peg-Intron is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical research on this drug for the treatment of Hepatitis C.

What phase is Peg-Intron in?

Peg-Intron is currently 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 a clinical trial to evaluate its safety and clinical activity in patients with Hepatitis C.

What clinical trials is Peg-Intron in?

Peg-Intron has one completed clinical trial, identified as NCT00367887, titled 'A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects.' This Phase 2 study enrolled 246 participants with Hepatitis C in the United States and Puerto Rico.

Is Peg-Intron the same as HCV-796?

Yes, Peg-Intron is also known as HCV-796. The clinical trial NCT00367887, which evaluates the safety and clinical activity of HCV-796, is the study for Peg-Intron. This alternative name is used in the trial title and documentation.