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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR OLYSIO

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Clinical Trials for Olysio

Trial ID Title Status Sponsor Phase Summary
NCT02118597 An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients Terminated Hoffmann-La Roche N/A This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.
NCT02168361 The SIM-SOF Trial for Hepatitis C Completed Center For Hepatitis C, Atlanta, GA Phase 4 Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.
NCT02206932 A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C Withdrawn Janssen Scientific Affairs, LLC Phase 4 This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.
NCT02206932 A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C Withdrawn University of California, San Francisco Phase 4 This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.
NCT02455167 Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis Active, not recruiting Janssen Scientific Affairs, LLC Phase 3 1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV). 2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.
NCT02455167 Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis Active, not recruiting University of Colorado, Denver Phase 3 1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV). 2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.
NCT02485080 Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1 Withdrawn Janssen Scientific Affairs, LLC Phase 4 The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Olysio

Condition Name

Condition Name for Olysio
Intervention Trials
Hepatitis C, Chronic 2
Hepatitis C 2
Chronic Hepatitis C 2
PT-NANBH 1
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Condition MeSH

Condition MeSH for Olysio
Intervention Trials
Hepatitis C 7
Hepatitis 6
Hepatitis C, Chronic 5
Hepatitis A 5
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Clinical Trial Locations for Olysio

Trials by Country

Trials by Country for Olysio
Location Trials
United States 5
France 1
Hungary 1
Egypt 1
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Trials by US State

Trials by US State for Olysio
Location Trials
California 2
Connecticut 1
Colorado 1
Georgia 1
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Clinical Trial Progress for Olysio

Clinical Trial Phase

Clinical Trial Phase for Olysio
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Olysio
Clinical Trial Phase Trials
Withdrawn 2
Completed 2
Active, not recruiting 1
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Clinical Trial Sponsors for Olysio

Sponsor Name

Sponsor Name for Olysio
Sponsor Trials
Janssen Scientific Affairs, LLC 3
Center For Hepatitis C, Atlanta, GA 1
Achillion Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Olysio
Sponsor Trials
Industry 6
Other 6
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Serving hundreds of leading biopharmaceutical companies globally:

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