drugset / Trial / NCT02327702
Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients
Phase 4
Unknown
200 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-randomizedSingle-groupOpen-labelTreatment
Summary
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.
Timeline
- Start
- 2015-01
- Primary completion
- 2015-07
- Completion
- 2017-07
Publications
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | emtricitabine | Other / unclassified | 200 mg | — |