Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease

NCT ID: NCT02691728

Last Updated: 2016-02-25

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-05-31

Brief Summary

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This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in patients with Chronic GT1 or GT4 HCV infection and autoimmune disease

Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

12 Week treatment with LDV/SOF FDC

Group Type EXPERIMENTAL

LDV/SOF FDC

Intervention Type DRUG

Interventions

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LDV/SOF FDC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic GT1 or GT4 HCV Infection
* Diagnosed with autoimmune disease (rheumatoid arthritis, psoriatic arthritis, lupus, etc.) and is currently receiving treatment for the condition.

Exclusion Criteria

* Infection with HIV or HBV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Peter J. Ruane, M.D., Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peter J. Ruane, MD, Inc.

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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IN_US-337-1748

Identifier Type: -

Identifier Source: org_study_id

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