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

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

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: LDV/SOF FDC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02691728

IN_US-337-1748

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment Arm

Experimental group

Description:

12 Week treatment with LDV/SOF FDC

Treatment:

Drug: LDV/SOF FDC