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HCV-796

Phase 2

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

HCV-796 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Apr 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment273

FDA Designations

No designations recorded

HCV-796 clinical trials

HCV-796 · 2 trials · 2 indications

Phase 2 1Phase 1 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
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
7 days

Secondary Endpoints

To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
15 days
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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
HCV-796DRUGHCV-796 1000mg single dose
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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 13 trials

Top 1 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir
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Frequently asked questions about HCV-796

What is HCV-796 used for?

HCV-796 is an investigational small molecule developed for the treatment of hepatitis C, a viral infection of the liver. It was studied in treatment-naive and non-responder patients with hepatitis C, as well as in subjects with liver disease. It is not an approved therapy and remains in clinical development.

Who is developing HCV-796?

HCV-796 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both clinical trials of the compound, including a Phase 2 study in hepatitis C patients and a Phase 1 study in subjects with liver disease and healthy adults.

What phase is HCV-796 in?

HCV-796 reached Phase 2 clinical development for hepatitis C. Both of its registered trials are completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is HCV-796 in?

HCV-796 was studied in two completed trials. NCT00367887 was a Phase 2 study evaluating safety and clinical activity in treatment-naive and non-responder hepatitis C subjects, enrolling 246 patients in the United States and Puerto Rico. NCT00314054 was a Phase 1 safety study in 27 subjects with liver disease and healthy adults.

Is HCV-796 the same as HCV 796?

Yes, HCV-796 and HCV 796 refer to the same investigational compound. The hyphenated form HCV-796 is the standard spelling used in trial registrations and scientific literature, while HCV 796 is a common variant without the hyphen. Both names describe the same Pfizer hepatitis C candidate.

How many patients were enrolled in HCV-796 trials?

Across its two completed trials, HCV-796 enrolled a total of 273 participants. The Phase 2 study NCT00367887 accounted for 246 of those subjects, and the Phase 1 study NCT00314054 enrolled 27 subjects, including healthy adults and individuals with liver disease.