NCT03480269 - 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)

Cavalcante LN, Lyra AC
Predictive factors associated with hepatitis C antiviral therapy response. World J Hepatol. 2015 Jun 28;7(12):1617-31. doi: 10.4254/wjh.v7.i12.1617. Review.
Childs K, Merritt E, Considine A, Sanchez-Fueyo A, Agarwal K, Martinez-Llordella M, Carey I
Immunological Predictors of Nonresponse to Directly Acting Antiviral Therapy in Patients With Chronic Hepatitis C and Decompensated Cirrhosis. Open Forum Infect Dis. 2017 Apr 3;4(2):ofx067. doi: 10.1093/ofid/ofx067. eCollection 2017 Spring.
Patel K, Lucas JE, Thompson JW, Dubois LG, Tillmann HL, Thompson AJ, Uzarski D, Califf RM, Moseley MA, Ginsburg GS, McHutchison JG, McCarthy JJ; MURDOCK Horizon 1 Study Team
High predictive accuracy of an unbiased proteomic profile for sustained virologic response in chronic hepatitis C patients. Hepatology. 2011 Jun;53(6):1809-18. doi: 10.1002/hep.24284. Epub 2011 May 14.
Yakoot M, Abdo AM, Yousry A, Helmy S
Very rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapy. Drug Des Devel Ther. 2016 Aug 25;10:2659-67. doi: 10.2147/DDDT.S111496. eCollection 2016.
Yek C, de la Flor C, Marshall J, Zoellner C, Thompson G, Quirk L, Mayorga C, Turner BJ, Singal AG, Jain MK
Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system: a retrospective cohort study. BMC Med. 2017 Nov 20;15(1):204. doi: 10.1186/s12916-017-0969-3.

Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease

Clinical trial NCT03480269 - References