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

NCT02253550 | Completed Phase 2

• 1 other identifier: TMC435HPC2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sustained Virologic Response 4 and 24 Weeks after Treatment Completion

  4 and 24 weeks post-treatment

Study Arms (2)

Cirrhosis

EXPERIMENTAL

Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir

Drug: Simeprevir; Drug: Sofosbuvir

Non-Cirrhotic

EXPERIMENTAL

Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir

Drug: Simeprevir; Drug: Sofosbuvir

Interventions

Simeprevir DRUG

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.

Also known as: Olysio; TMC435

Cirrhosis; Non-Cirrhotic

Sofosbuvir DRUG

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

Also known as: Sovaldi; GS-7977; PSI-7977

Cirrhosis; Non-Cirrhotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV genotype 4 infection
• HCV RNA \>10,000 IU/mL at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter J. Ruane, M.D.: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Peter J. Ruane, MD, Inc.

Los Angeles, California, 90036, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Simeprevir; Sofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Peter J Ruane, MD

  Peter J. Ruane, MD, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, President

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

US (1)