drugset / Trial / NCT02327663
Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
Phase 4
Unknown
2000 enrolled
Asian-Pacific Alliance of Liver Disease, Beijing
Beijing Ditan Hospital · collabHebei Medical University Pharmaceutical Factory · collabNational Health and Family Planning Commission, P.R.China · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
Timeline
- Start
- 2014-12
- Primary completion
- 2017-06
- Completion
- 2017-12
Publications
- Background Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.
- Results Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |