Clinical trial NCT02253550: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Peter J. Ruane, M.D., Inc.
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2014-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
timeFrame: 12 weeks post-treatment
Secondary outcomes:
measure: Sustained Virologic Response 4 and 24 Weeks after Treatment Completion
timeFrame: 4 and 24 weeks post-treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
Study officials:
affiliation: Peter J. Ruane, MD, Inc.
name: Peter J Ruane, MD
role: PRINCIPAL_INVESTIGATOR
References: