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Article: A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B

TitleA randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B
Authors
Issue Date2006
PublisherInternational Medical Press. The Journal's web site is located at http://www.intmedpress.com/Journals/AVT/journals_avt_home.cfm
Citation
Antiviral Therapy, 2006, v. 11 n. 8, p. 977-983 How to Cite?
AbstractBackground: LB80380 is potent antiviral agent against hepatitis B virus (HBV) in vitro and in the woodchuck model. It has an excellent preclinical safety profile including lower potential for renal toxicity than adefovir. It is effective against both wild-type and YMDD mutant HBV. LB80380 is converted to its parent drug, LB80331, after oral absorption, and further metabolized to its active form, LB80317. Aims/Methods: This randomized placebo-controlled Phase I/II clinical study of LB80380 was conducted to assess the safety, antiviral activity and pharmacokinetics of its parent drug LB80331 and its active form LB80317 in 29 Asian adults with chronic hepatitis B positive for hepatitis B e antigen in four escalating dose groups (30, 60, 120 and 240 mg once per day) for 4 weeks with a 12-week follow-up period. Results: The mean maximum HBV DNA reduction was 3.05, 4.20, 3.67 and 3.68 log10 copies/ml for 30, 60, 120 and 240 mg per day, respectively. Viral dynamic analysis suggested a high degree of inhibition of HBV replication at doses of 60 mg or higher per day. LB80380 was well tolerated at all dose groups, and no dose-related clinical or laboratory adverse event was reported. Conclusion: LB80380 is shown to be a potent and safe antiviral agent for HBV. Marked HBV DNA suppression was observed in all dose groups. The HBV DNA suppression was approximately constant at doses of 60 mg and higher over the 28-day dosing period. The dose response of LB80380 will be evaluated further in large clinical studies. © 2006 International Medical Press.
Persistent Identifierhttp://hdl.handle.net/10722/77388
ISSN
2015 Impact Factor: 2.916
2015 SCImago Journal Rankings: 1.361
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorYuen, MFen_HK
dc.contributor.authorKim, Jen_HK
dc.contributor.authorKim, CRen_HK
dc.contributor.authorNgai, Ven_HK
dc.contributor.authorYuen, JCHen_HK
dc.contributor.authorMin, Cen_HK
dc.contributor.authorKang, HMen_HK
dc.contributor.authorShin, BSen_HK
dc.contributor.authorYoo, SDen_HK
dc.contributor.authorLai, CLen_HK
dc.date.accessioned2010-09-06T07:31:22Z-
dc.date.available2010-09-06T07:31:22Z-
dc.date.issued2006en_HK
dc.identifier.citationAntiviral Therapy, 2006, v. 11 n. 8, p. 977-983en_HK
dc.identifier.issn1359-6535en_HK
dc.identifier.urihttp://hdl.handle.net/10722/77388-
dc.description.abstractBackground: LB80380 is potent antiviral agent against hepatitis B virus (HBV) in vitro and in the woodchuck model. It has an excellent preclinical safety profile including lower potential for renal toxicity than adefovir. It is effective against both wild-type and YMDD mutant HBV. LB80380 is converted to its parent drug, LB80331, after oral absorption, and further metabolized to its active form, LB80317. Aims/Methods: This randomized placebo-controlled Phase I/II clinical study of LB80380 was conducted to assess the safety, antiviral activity and pharmacokinetics of its parent drug LB80331 and its active form LB80317 in 29 Asian adults with chronic hepatitis B positive for hepatitis B e antigen in four escalating dose groups (30, 60, 120 and 240 mg once per day) for 4 weeks with a 12-week follow-up period. Results: The mean maximum HBV DNA reduction was 3.05, 4.20, 3.67 and 3.68 log10 copies/ml for 30, 60, 120 and 240 mg per day, respectively. Viral dynamic analysis suggested a high degree of inhibition of HBV replication at doses of 60 mg or higher per day. LB80380 was well tolerated at all dose groups, and no dose-related clinical or laboratory adverse event was reported. Conclusion: LB80380 is shown to be a potent and safe antiviral agent for HBV. Marked HBV DNA suppression was observed in all dose groups. The HBV DNA suppression was approximately constant at doses of 60 mg and higher over the 28-day dosing period. The dose response of LB80380 will be evaluated further in large clinical studies. © 2006 International Medical Press.en_HK
dc.languageengen_HK
dc.publisherInternational Medical Press. The Journal's web site is located at http://www.intmedpress.com/Journals/AVT/journals_avt_home.cfmen_HK
dc.relation.ispartofAntiviral Therapyen_HK
dc.subject.meshAdulten_HK
dc.subject.meshAntiviral Agents - administration & dosage - adverse effects - pharmacokinetics - therapeutic useen_HK
dc.subject.meshDose-Response Relationship, Drugen_HK
dc.subject.meshFemaleen_HK
dc.subject.meshGuanine - administration & dosage - adverse effects - analogs & derivatives - pharmacokinetics - therapeutic useen_HK
dc.subject.meshHepatitis B e Antigens - blooden_HK
dc.subject.meshHepatitis B, Chronic - blood - drug therapyen_HK
dc.subject.meshHumansen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMiddle Ageden_HK
dc.subject.meshMolecular Structureen_HK
dc.subject.meshPhosphonic Acids - administration & dosage - adverse effects - pharmacokinetics - therapeutic useen_HK
dc.titleA randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=1359-6535&volume=11&issue=8&spage=977&epage=983&date=2006&atitle=A+Randomized+Placebo-controlled,+Dose-finding+Study+of+Oral+LB80380+in+HBeAg-positive+Patients+with+Chronic+Hepatitis+Ben_HK
dc.identifier.emailYuen, MF:mfyuen@hkucc.hku.hken_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityYuen, MF=rp00479en_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.pmid17302367-
dc.identifier.scopuseid_2-s2.0-33845675035en_HK
dc.identifier.hkuros130673en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33845675035&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume11en_HK
dc.identifier.issue8en_HK
dc.identifier.spage977en_HK
dc.identifier.epage983en_HK
dc.identifier.isiWOS:000243183100003-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridYuen, MF=7102031955en_HK
dc.identifier.scopusauthoridKim, J=9744730600en_HK
dc.identifier.scopusauthoridKim, CR=7409872688en_HK
dc.identifier.scopusauthoridNgai, V=15061738300en_HK
dc.identifier.scopusauthoridYuen, JCH=7102620480en_HK
dc.identifier.scopusauthoridMin, C=36340347200en_HK
dc.identifier.scopusauthoridKang, HM=15725582900en_HK
dc.identifier.scopusauthoridShin, BS=36341306500en_HK
dc.identifier.scopusauthoridYoo, SD=7401970877en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK

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