Back to resultsStudy 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
Primary Purpose
Chronic Hepatitis C
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LDV/SOF FDC
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
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
Sites / Locations
- Peter J. Ruane, MD, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
12 Week treatment with LDV/SOF FDC
Outcomes
Primary Outcome Measures
SVR12 (Sustained Virologic Response)
Secondary Outcome Measures
Full Information
NCT ID
NCT02691728
First Posted
February 22, 2016
Last Updated
February 24, 2016
Sponsor
Peter J. Ruane, M.D., Inc.
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02691728
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter J. Ruane, M.D., Inc.
Collaborators
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
12 Week treatment with LDV/SOF FDC
Intervention Type
Drug
Intervention Name(s)
LDV/SOF FDC
Primary Outcome Measure Information:
Title
SVR12 (Sustained Virologic Response)
Time Frame
Sustained Virologic Response 12 Weeks after Treatment Completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peter J. Ruane, MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
12. IPD Sharing Statement
Learn more about this 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
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