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
Phase 4
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: LDV/SOF FDC
- Registration Number
- NCT02691728
- Lead Sponsor
- Peter J. Ruane, M.D., Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm LDV/SOF FDC 12 Week treatment with LDV/SOF FDC
- Primary Outcome Measures
Name Time Method SVR12 (Sustained Virologic Response) Sustained Virologic Response 12 Weeks after Treatment Completion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peter J. Ruane, MD, Inc.
🇺🇸Los Angeles, California, United States