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A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers

NCT ID: NCT00522808

Last Updated: 2008-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-05-31

Brief Summary

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The purposes of this study are:

* to determine the safety and tolerability of multiple doses of A-831 at various doses
* to determine how multiple doses of A-831 are distributed through the bloodstream
* to determine if A-831 reduces the amount of Hepatitis C virus in the blood

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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HCV antiviral PK Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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A-831

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical
* Volunteers who have given their written informed consent to participate in the study
* Volunteers who are willing and able to comply with the protocol and study procedures
* Volunteers who have a diagnosis of chronic hepatitis C infection and are in good health (other than history of Hepatitis C infection)

Exclusion Criteria

* Voulnteers with concurrent medical conditions or taking concurrent medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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DDS, Dundee

UNKNOWN

Sponsor Role collaborator

David Mutimer, Birmingham

UNKNOWN

Sponsor Role collaborator

Ed Gane, ACS New Zealand

UNKNOWN

Sponsor Role collaborator

Arrow Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Arrow Therapeutics

Principal Investigators

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Brian Sanderson

Role: PRINCIPAL_INVESTIGATOR

DDS

David Mutimer

Role: PRINCIPAL_INVESTIGATOR

WTCRF Birmingham

Edward Gane

Role: PRINCIPAL_INVESTIGATOR

ACS New Zealand

Locations

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ACS

Auckland, , New Zealand

Site Status

Birmingham WTCRF

Birmingham, , United Kingdom

Site Status

DDS

Dundee, , United Kingdom

Site Status

Countries

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New Zealand United Kingdom

Other Identifiers

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CP104

Identifier Type: -

Identifier Source: org_study_id