File Download
 
Links for fulltext
(May Require Subscription)
 
Supplementary

Article: A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B
  • Basic View
  • Metadata View
  • XML View
TitleA randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B
 
AuthorsYuen, MF2
Kim, J1
Kim, CR1
Ngai, V2
Yuen, JCH2
Min, C1
Kang, HM1
Shin, BS3
Yoo, SD3
Lai, CL2
 
Issue Date2006
 
PublisherInternational Medical Press. The Journal's web site is located at http://www.intmedpress.com/Journals/AVT/journals_avt_home.cfm
 
CitationAntiviral 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.
 
ISSN1359-6535
2013 Impact Factor: 3.143
2013 SCImago Journal Rankings: 1.542
 
ISI Accession Number IDWOS:000243183100003
 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorYuen, MF
 
dc.contributor.authorKim, J
 
dc.contributor.authorKim, CR
 
dc.contributor.authorNgai, V
 
dc.contributor.authorYuen, JCH
 
dc.contributor.authorMin, C
 
dc.contributor.authorKang, HM
 
dc.contributor.authorShin, BS
 
dc.contributor.authorYoo, SD
 
dc.contributor.authorLai, CL
 
dc.date.accessioned2010-09-06T07:31:22Z
 
dc.date.available2010-09-06T07:31:22Z
 
dc.date.issued2006
 
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.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationAntiviral Therapy, 2006, v. 11 n. 8, p. 977-983 [How to Cite?]
 
dc.identifier.epage983
 
dc.identifier.hkuros130673
 
dc.identifier.isiWOS:000243183100003
 
dc.identifier.issn1359-6535
2013 Impact Factor: 3.143
2013 SCImago Journal Rankings: 1.542
 
dc.identifier.issue8
 
dc.identifier.openurl
 
dc.identifier.pmid17302367
 
dc.identifier.scopuseid_2-s2.0-33845675035
 
dc.identifier.spage977
 
dc.identifier.urihttp://hdl.handle.net/10722/77388
 
dc.identifier.volume11
 
dc.languageeng
 
dc.publisherInternational Medical Press. The Journal's web site is located at http://www.intmedpress.com/Journals/AVT/journals_avt_home.cfm
 
dc.publisher.placeUnited Kingdom
 
dc.relation.ispartofAntiviral Therapy
 
dc.relation.referencesReferences in Scopus
 
dc.subject.meshAdult
 
dc.subject.meshAntiviral Agents - administration & dosage - adverse effects - pharmacokinetics - therapeutic use
 
dc.subject.meshDose-Response Relationship, Drug
 
dc.subject.meshFemale
 
dc.subject.meshGuanine - administration & dosage - adverse effects - analogs & derivatives - pharmacokinetics - therapeutic use
 
dc.subject.meshHepatitis B e Antigens - blood
 
dc.subject.meshHepatitis B, Chronic - blood - drug therapy
 
dc.subject.meshHumans
 
dc.subject.meshMale
 
dc.subject.meshMiddle Aged
 
dc.subject.meshMolecular Structure
 
dc.subject.meshPhosphonic Acids - administration & dosage - adverse effects - pharmacokinetics - therapeutic use
 
dc.titleA randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B
 
dc.typeArticle
 
<?xml encoding="utf-8" version="1.0"?>
<item><contributor.author>Yuen, MF</contributor.author>
<contributor.author>Kim, J</contributor.author>
<contributor.author>Kim, CR</contributor.author>
<contributor.author>Ngai, V</contributor.author>
<contributor.author>Yuen, JCH</contributor.author>
<contributor.author>Min, C</contributor.author>
<contributor.author>Kang, HM</contributor.author>
<contributor.author>Shin, BS</contributor.author>
<contributor.author>Yoo, SD</contributor.author>
<contributor.author>Lai, CL</contributor.author>
<date.accessioned>2010-09-06T07:31:22Z</date.accessioned>
<date.available>2010-09-06T07:31:22Z</date.available>
<date.issued>2006</date.issued>
<identifier.citation>Antiviral Therapy, 2006, v. 11 n. 8, p. 977-983</identifier.citation>
<identifier.issn>1359-6535</identifier.issn>
<identifier.uri>http://hdl.handle.net/10722/77388</identifier.uri>
<description.abstract>Background: 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. &#169; 2006 International Medical Press.</description.abstract>
<language>eng</language>
<publisher>International Medical Press. The Journal&apos;s web site is located at http://www.intmedpress.com/Journals/AVT/journals_avt_home.cfm</publisher>
<relation.ispartof>Antiviral Therapy</relation.ispartof>
<subject.mesh>Adult</subject.mesh>
<subject.mesh>Antiviral Agents - administration &amp; dosage - adverse effects - pharmacokinetics - therapeutic use</subject.mesh>
<subject.mesh>Dose-Response Relationship, Drug</subject.mesh>
<subject.mesh>Female</subject.mesh>
<subject.mesh>Guanine - administration &amp; dosage - adverse effects - analogs &amp; derivatives - pharmacokinetics - therapeutic use</subject.mesh>
<subject.mesh>Hepatitis B e Antigens - blood</subject.mesh>
<subject.mesh>Hepatitis B, Chronic - blood - drug therapy</subject.mesh>
<subject.mesh>Humans</subject.mesh>
<subject.mesh>Male</subject.mesh>
<subject.mesh>Middle Aged</subject.mesh>
<subject.mesh>Molecular Structure</subject.mesh>
<subject.mesh>Phosphonic Acids - administration &amp; dosage - adverse effects - pharmacokinetics - therapeutic use</subject.mesh>
<title>A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B</title>
<type>Article</type>
<identifier.openurl>http://library.hku.hk:4550/resserv?sid=HKU:IR&amp;issn=1359-6535&amp;volume=11&amp;issue=8&amp;spage=977&amp;epage=983&amp;date=2006&amp;atitle=A+Randomized+Placebo-controlled,+Dose-finding+Study+of+Oral+LB80380+in+HBeAg-positive+Patients+with+Chronic+Hepatitis+B</identifier.openurl>
<description.nature>Link_to_subscribed_fulltext</description.nature>
<identifier.pmid>17302367</identifier.pmid>
<identifier.scopus>eid_2-s2.0-33845675035</identifier.scopus>
<identifier.hkuros>130673</identifier.hkuros>
<relation.references>http://www.scopus.com/mlt/select.url?eid=2-s2.0-33845675035&amp;selection=ref&amp;src=s&amp;origin=recordpage</relation.references>
<identifier.volume>11</identifier.volume>
<identifier.issue>8</identifier.issue>
<identifier.spage>977</identifier.spage>
<identifier.epage>983</identifier.epage>
<identifier.isi>WOS:000243183100003</identifier.isi>
<publisher.place>United Kingdom</publisher.place>
</item>
Author Affiliations
  1. LG
  2. The University of Hong Kong
  3. Sungkyunkwan University