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Conference Paper: L-DT: an ongoing phase I/II dose escalation trial in patients with chronic HBV infection (NV-02B-001)

TitleL-DT: an ongoing phase I/II dose escalation trial in patients with chronic HBV infection (NV-02B-001)
Authors
Issue Date2001
PublisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep
Citation
The 36th Annual Meeting of the European Association for the Study of the Liver, Prague, Czech Republic, 18-22 April 2001. In Journal of Hepatology, 2001, v. 34 n. S1, p. 139 Abstract no. 298 How to Cite?
AbstractIntroduction: L-dT (fl-L-2'deoxythymidine) is a novel L-nucleoside shown to be a hightly specific and potent inhibitor of HBV DNA polymerase and HBV replication in vitro. Methods: NV-02B-001 is a blinded dose escalation trial to evaluate the pK, safety and efficacy of L-dT at once daily doses starting at 25 mg. 7 HBeAg(+) patients are to be enrolled in each of the sequential dose cohorts (25, 50, 100, 200 and 400 mg) at a ratio of 6:1 (L-dT: placebo). Dose limiting toxicities (DLTs) must be <2 in any given cohort in order to dose-escalate to subsequent cohorts. The primary efficacy measure is plasma HBV DNA, measured by COBAS Amplicor HBV Monitor TM Assay. Results: 7 patients have completed the 28-day active treatment phase of the 1 st dose (25 rag) cohort. The median baseline viral load (log10 C/mL) was 9.72. The median change in viral load from baseline to Day 28 was - 2.5 log[0 C/mL for the 6 actively treated patients. No serious adverse events or DLTs have been reported to date. Conclusion: Preliminary safety and antiviral activity data have shown L-dT to be active and well tolerated in patients enrolled in the 1 st and lowest dose cohort.
Persistent Identifierhttp://hdl.handle.net/10722/101204
ISSN
2015 Impact Factor: 10.59
2015 SCImago Journal Rankings: 4.570

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_HK
dc.contributor.authorLim, SG-
dc.contributor.authorYuen, MF-
dc.contributor.authorPow, DM-
dc.contributor.authorMyers, MW-
dc.date.accessioned2010-09-25T19:40:07Z-
dc.date.available2010-09-25T19:40:07Z-
dc.date.issued2001en_HK
dc.identifier.citationThe 36th Annual Meeting of the European Association for the Study of the Liver, Prague, Czech Republic, 18-22 April 2001. In Journal of Hepatology, 2001, v. 34 n. S1, p. 139 Abstract no. 298-
dc.identifier.issn0168-8278-
dc.identifier.urihttp://hdl.handle.net/10722/101204-
dc.description.abstractIntroduction: L-dT (fl-L-2'deoxythymidine) is a novel L-nucleoside shown to be a hightly specific and potent inhibitor of HBV DNA polymerase and HBV replication in vitro. Methods: NV-02B-001 is a blinded dose escalation trial to evaluate the pK, safety and efficacy of L-dT at once daily doses starting at 25 mg. 7 HBeAg(+) patients are to be enrolled in each of the sequential dose cohorts (25, 50, 100, 200 and 400 mg) at a ratio of 6:1 (L-dT: placebo). Dose limiting toxicities (DLTs) must be <2 in any given cohort in order to dose-escalate to subsequent cohorts. The primary efficacy measure is plasma HBV DNA, measured by COBAS Amplicor HBV Monitor TM Assay. Results: 7 patients have completed the 28-day active treatment phase of the 1 st dose (25 rag) cohort. The median baseline viral load (log10 C/mL) was 9.72. The median change in viral load from baseline to Day 28 was - 2.5 log[0 C/mL for the 6 actively treated patients. No serious adverse events or DLTs have been reported to date. Conclusion: Preliminary safety and antiviral activity data have shown L-dT to be active and well tolerated in patients enrolled in the 1 st and lowest dose cohort.-
dc.languageengen_HK
dc.publisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep-
dc.relation.ispartofJournal of Hepatologyen_HK
dc.titleL-DT: an ongoing phase I/II dose escalation trial in patients with chronic HBV infection (NV-02B-001)en_HK
dc.typeConference_Paperen_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/S0168-8278(01)81382-9-
dc.identifier.hkuros62052en_HK

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