Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253550
• Other study ID #: TMC435HPC2012
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2014
• Last updated: February 22, 2016
• Start date: October 2014
• Est. completion date: January 2016

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• Simeprevir
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.
• Sofosbuvir
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.

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.	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)	HCV RNA will be measured 12 weeks post-treatment to evaluate SVR	12 weeks post-treatment	No
Secondary	Sustained Virologic Response 4 and 24 Weeks after Treatment Completion	HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR	4 and 24 weeks post-treatment	No