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NCT02691728 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02691728
Other study ID # IN_US-337-1748
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received February 22, 2016
Last updated February 24, 2016
Start date February 2016
Est. completion date May 2017

Study information
Verified date February 2016
Source Peter J. Ruane, M.D., Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date May 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• LDV/SOF FDC

Locations
Country Name City State
United States Peter J. Ruane, MD, Inc. Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Peter J. Ruane, M.D., Inc. Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary SVR12 (Sustained Virologic Response) Sustained Virologic Response 12 Weeks after Treatment Completion No
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