NCT02601976 - 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)

Abbas Z, Jeswani NL, Kakepoto GN, Islam M, Mehdi K, Jafri W
Prevalence and mode of spread of hepatitis B and C in rural Sindh, Pakistan. Trop Gastroenterol. 2008 Oct-Dec;29(4):210-6.
Ahmad, T
, R. Ahsan, and G. Saba. Evaluation of Safety and Pharmacokinetic Behavior of Unipeg® in Healthy Human Volunteers. Journal of Pharmacy and Nutrition Sciences 2014;4.3:220-227
Ali SA, Donahue RM, Qureshi H, Vermund SH
Hepatitis B and hepatitis C in Pakistan: prevalence and risk factors. Int J Infect Dis. 2009 Jan;13(1):9-19. doi: 10.1016/j.ijid.2008.06.019. Epub 2008 Oct 2. Review.
Chander G, Sulkowski MS, Jenckes MW, Torbenson MS, Herlong HF, Bass EB, Gebo KA
Treatment of chronic hepatitis C: a systematic review. Hepatology. 2002 Nov;36(5 Suppl 1):S135-44. Review.
European Association for Study of Liver
EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21.
Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group
Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55.
Idrees M, Riazuddin S
Frequency distribution of hepatitis C virus genotypes in different geographical regions of Pakistan and their possible routes of transmission. BMC Infect Dis. 2008 May 23;8:69. doi: 10.1186/1471-2334-8-69.

Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection

Details for clinical trial NCT02601976

Clinical trial NCT02601976 - References