Clinical Development Plan for Hepatitis B Treatment: NZMS-202 Hepviva COMPOUND OVERVIEW Target Compound: NZMS-202 Trade Name: Hepviva Generic Name: Trantipadine Therapeutic Area: Infectious Disease Indication: Hepatitis B Dosing: 50 mg coated tablet Administration: Oral tablet Monotherapy or Combo Therapy: Monotherapy and in combination w/ other Antivirals Drug or Biologic: Nucleoside analog reverse transcriptase inhibitor (NRTI) antiviral Current Stage of Development: 30 days post-IND submission to FDA Table of Contents Section 1: Project Overview Section 2: Communication Plan Section 3: Project Timeline Section 4: Non-Clinical Plan Section 5:Clinical Trials Overview Section 6:Data Management Plan Section 7:Regulatory Strategy Section...The end:
.....marked%20Practice%20Guidelines/Chronic_Hep_B_Update_2009%208_24_2009.pdf. Marcellin , P., Lau, G.K., Bonino , F., Farci , P., Hadziyannis , S., Jin, R., et al. (2004). Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg -negative chronic hepatitis B. New England Journal of Medicine, 351(12): 1206 - 1217. National Institutes of Health. (2010). Hepatitis B. Medline Plus Website. Last updated January 2010. Retrieved February 1, 2010, http://www.nlm.nih.gov/medlineplus/hepatitisb.html. National Institutes of Health. (2010b). Understanding clinical trials. ClinicalTrials.gov Website. Lasted updated September 20, 2007. Retrieved February 10, 2010, from http://clinicaltrials.gov/ct2/info/understand#Q20.