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Conference Paper: Placebo-controlled trial of antibody to connective tissue growth factor (CTGF) in HBV liver fibrosis

TitlePlacebo-controlled trial of antibody to connective tissue growth factor (CTGF) in HBV liver fibrosis
Authors
Issue Date2016
PublisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0
Citation
The 25th Annual Conference of Asian Pacific Association for the Study of the Liver (APASL 2016), Tokyo, Japan, 20-24 February 2016. In Hepatology International, 2016, v. 10 n. 1 suppl., p. S245, abstract no. P-0415 How to Cite?
AbstractINTRODUCTION: CTGF is a matricellular glycoprotein and central mediator of tissue remodeling and fibrosis. CTGF levels are elevated in viral hepatitis and NASH liver tissue. Inhibition of CTGF-expression prevents liver fibrosis in mouse models. FG-3019 is a human mAb to CTGF that is being developed to treat advanced liver fibrosis. METHODS: 114 subjects with chronic hepatitisB (HBV) in Asia, naı¨ve to antiviral therapy with Ishak C2 (amended to C3), were randomized 2:1 to entecavir+FG-3019 (15 and 45 mg/kg IV, Q3 W, for 45 weeks) or entecavir+placebo. The primary endpoint was the proportion of subjects with C1 point improvement in Ishak fibrosis score at 48 weeks (response rate) versus baseline. ClinicalTrials.gov: NCT01217632. RESULTS: Although the study is closed, data are not yet unblinded. FG-3019/placebo with entecavir showed excellent safety and tolerability at both dose levels: Neither local nor systemic allergic reactions were reported. At end of treatment,[95 % of subjects had undetectable viral load, and the majority normalized ALTs. No abnormal laboratory trends and no evidence of liver decompensation were noted. Ishak score change is available in 76 subjects: 21 had decrease of 1 point, 18 of 2 points, 5 of C3 points, 26 were stable and 6 had increased score for an aggregate response rate of 57.9 %. Unblinded data will be presented at a subsequent congress. CONCLUSIONS: FG-3019+ entecavir was well-tolerated in subjects with advanced HBV fibrosis and FG-3019 did not appear to impair entecavir’s antiviral efficacy.
DescriptionThis journal suppl. entitled: Conference Abstracts: 25th Annual Conference of APASL, February 20–24, 2016, Tokyo, Japan
Poster presentation: P-0415
Persistent Identifierhttp://hdl.handle.net/10722/234176
ISSN
2015 Impact Factor: 1.125
2015 SCImago Journal Rankings: 0.669

 

DC FieldValueLanguage
dc.contributor.authorLai, CL-
dc.contributor.authorHui, A-
dc.contributor.authorChan, HLY-
dc.contributor.authorHemmerich, S-
dc.contributor.authorModelska, K-
dc.contributor.authorNeff, TB-
dc.contributor.authorImperial, JC-
dc.contributor.authorPorter, S-
dc.contributor.authorValone, FH-
dc.date.accessioned2016-10-14T06:59:37Z-
dc.date.available2016-10-14T06:59:37Z-
dc.date.issued2016-
dc.identifier.citationThe 25th Annual Conference of Asian Pacific Association for the Study of the Liver (APASL 2016), Tokyo, Japan, 20-24 February 2016. In Hepatology International, 2016, v. 10 n. 1 suppl., p. S245, abstract no. P-0415-
dc.identifier.issn1936-0533-
dc.identifier.urihttp://hdl.handle.net/10722/234176-
dc.descriptionThis journal suppl. entitled: Conference Abstracts: 25th Annual Conference of APASL, February 20–24, 2016, Tokyo, Japan-
dc.descriptionPoster presentation: P-0415-
dc.description.abstractINTRODUCTION: CTGF is a matricellular glycoprotein and central mediator of tissue remodeling and fibrosis. CTGF levels are elevated in viral hepatitis and NASH liver tissue. Inhibition of CTGF-expression prevents liver fibrosis in mouse models. FG-3019 is a human mAb to CTGF that is being developed to treat advanced liver fibrosis. METHODS: 114 subjects with chronic hepatitisB (HBV) in Asia, naı¨ve to antiviral therapy with Ishak C2 (amended to C3), were randomized 2:1 to entecavir+FG-3019 (15 and 45 mg/kg IV, Q3 W, for 45 weeks) or entecavir+placebo. The primary endpoint was the proportion of subjects with C1 point improvement in Ishak fibrosis score at 48 weeks (response rate) versus baseline. ClinicalTrials.gov: NCT01217632. RESULTS: Although the study is closed, data are not yet unblinded. FG-3019/placebo with entecavir showed excellent safety and tolerability at both dose levels: Neither local nor systemic allergic reactions were reported. At end of treatment,[95 % of subjects had undetectable viral load, and the majority normalized ALTs. No abnormal laboratory trends and no evidence of liver decompensation were noted. Ishak score change is available in 76 subjects: 21 had decrease of 1 point, 18 of 2 points, 5 of C3 points, 26 were stable and 6 had increased score for an aggregate response rate of 57.9 %. Unblinded data will be presented at a subsequent congress. CONCLUSIONS: FG-3019+ entecavir was well-tolerated in subjects with advanced HBV fibrosis and FG-3019 did not appear to impair entecavir’s antiviral efficacy.-
dc.languageeng-
dc.publisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0-
dc.relation.ispartofHepatology International-
dc.titlePlacebo-controlled trial of antibody to connective tissue growth factor (CTGF) in HBV liver fibrosis-
dc.typeConference_Paper-
dc.identifier.emailLai, CL: hrmelcl@hkucc.hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.identifier.doi10.1007/s12072-016-9707-8-
dc.identifier.hkuros267644-
dc.identifier.volume10-
dc.identifier.issue1 suppl.-
dc.identifier.spageS245, abstract no. P-0415-
dc.identifier.epageS245, abstract no. P-0415-
dc.publisher.placeUnited States-

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