Back to resultsSimeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Simeprevir
Sofosbuvir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- HCV genotype 4 infection
- HCV RNA >10,000 IU/mL at screening.
Exclusion Criteria:
- Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
- Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
- Infection/co-infection with HCV non-genotype 4.
- Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
- Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).
- Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator
- Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.
Sites / Locations
- Peter J. Ruane, MD, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cirrhosis
Non-Cirrhotic
Arm Description
Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
Outcomes
Primary Outcome Measures
Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
HCV RNA will be measured 12 weeks post-treatment to evaluate SVR
Secondary Outcome Measures
Sustained Virologic Response 4 and 24 Weeks after Treatment Completion
HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR
Full Information
NCT ID
NCT02253550
First Posted
September 17, 2014
Last Updated
February 22, 2016
Sponsor
Peter J. Ruane, M.D.
Collaborators
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02253550
Brief Title
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
Official Title
A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Without Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter J. Ruane, M.D.
Collaborators
Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.
Detailed Description
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.
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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cirrhosis
Arm Type
Experimental
Arm Description
Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
Arm Title
Non-Cirrhotic
Arm Type
Experimental
Arm Description
Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
Intervention Type
Drug
Intervention Name(s)
Simeprevir
Other Intervention Name(s)
Olysio; TMC435
Intervention Description
Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi; GS-7977; PSI-7977
Intervention Description
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Primary Outcome Measure Information:
Title
Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
Description
HCV RNA will be measured 12 weeks post-treatment to evaluate SVR
Time Frame
12 weeks post-treatment
Secondary Outcome Measure Information:
Title
Sustained Virologic Response 4 and 24 Weeks after Treatment Completion
Description
HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR
Time Frame
4 and 24 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCV genotype 4 infection
HCV RNA >10,000 IU/mL at screening.
Exclusion Criteria:
Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
Infection/co-infection with HCV non-genotype 4.
Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).
Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator
Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Ruane, MD
Organizational Affiliation
Peter J. Ruane, MD, Inc.
Official's Role
Principal Investigator
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
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
We'll reach out to this number within 24 hrs