NCT02485080 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Carrión JA, Martínez-Bauer E, Crespo G, Ramírez S, Pérez-del-Pulgar S, García-Valdecasas JC, Navasa M, Forns X
Antiviral therapy increases the risk of bacterial infections in HCV-infected cirrhotic patients awaiting liver transplantation: A retrospective study. J Hepatol. 2009 Apr;50(4):719-28. doi: 10.1016/j.jhep.2008.11.015. Epub 2008 Dec 29.
Iacobellis A, Siciliano M, Perri F, Annicchiarico BE, Leandro G, Caruso N, Accadia L, Bombardieri G, Andriulli A
Peginterferon alfa-2b and ribavirin in patients with hepatitis C virus and decompensated cirrhosis: a controlled study. J Hepatol. 2007 Feb;46(2):206-12. Epub 2006 Oct 20.
Roche B, Samuel D
Hepatitis C virus treatment pre- and post-liver transplantation. Liver Int. 2012 Feb;32 Suppl 1:120-8. doi: 10.1111/j.1478-3231.2011.02714.x. Review.

Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN

Details for clinical trial NCT02485080

Clinical trial NCT02485080 - References