NCT01821794 - 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)

Hoofnagle JH, Doo E, Liang TJ, Fleischer R, Lok AS
Management of hepatitis B: summary of a clinical research workshop. Hepatology. 2007 Apr;45(4):1056-75. Review.
Lok AS, McMahon BJ
Chronic hepatitis B. Hepatology. 2007 Feb;45(2):507-39. Erratum in: Hepatology. 2007 Jun;45(6):1347.
Shepard CW, Simard EP, Finelli L, Fiore AE, Bell BP
Hepatitis B virus infection: epidemiology and vaccination. Epidemiol Rev. 2006;28:112-25. Epub 2006 Jun 5. Review.

Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir DF Versus Tenofovir DF Monotherapy in HBeAg-Positive and HBeAg-Negative Chronic Hepatitis B

Details for clinical trial NCT01821794

Clinical trial NCT01821794 - References