Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

NCT ID: NCT00671671

Last Updated: 2014-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-12-31

Brief Summary

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Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

Detailed Description

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Conditions

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Hepatitis, Chronic Hepatitis C Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort B

Group Type EXPERIMENTAL

Small Molecule Agent (PF-868554)

Intervention Type DRUG

Study drug will be administered 700mg BID in the fed state for three days.

Cohort A

Dose study drug in subjects who have previously failed to respond to interferon based therapies

Group Type EXPERIMENTAL

Small Molecule Agent (PF-868554)

Intervention Type DRUG

Study drug will be given 450mg BID for a duration of 10 days.

Interventions

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Small Molecule Agent (PF-868554)

Study drug will be administered 700mg BID in the fed state for three days.

Intervention Type DRUG

Small Molecule Agent (PF-868554)

Study drug will be given 450mg BID for a duration of 10 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

HCV Positive With HCV RNA\>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

Exclusion Criteria

HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than HCV, AFP\>200ng/ml
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Wagner F, Thompson R, Kantaridis C, Simpson P, Troke PJ, Jagannatha S, Neelakantan S, Purohit VS, Hammond JL. Antiviral activity of the hepatitis C virus polymerase inhibitor filibuvir in genotype 1-infected patients. Hepatology. 2011 Jul;54(1):50-9. doi: 10.1002/hep.24342.

Reference Type DERIVED
PMID: 21488067 (View on PubMed)

Related Links

Other Identifiers

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A8121006

Identifier Type: -

Identifier Source: org_study_id

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