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

A Phase 4, Open-Label 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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02691728

Enrollment

Registered

2016-02-25

Start date

2016-02-29

Completion date

2017-05-31

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief summary

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

Interventions

DRUGLDV/SOF FDC

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
SVR12 (Sustained Virologic Response)	Sustained Virologic Response 12 Weeks after Treatment Completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026