Evidence map›Paper›PMID 31258695›Full record

ArticleExperimental and therapeutic medicine2019

Eltrombopag enables initiation and completion of pegylated interferon/ribavirin therapy in Japanese HCV-infected patients with chronic liver disease and thrombocytopenia.

Takumi Kawaguchi, Atsumasa Komori, Kunio Fujisaki, Shuhei Nishiguchi, Michio Kato, Hitoshi Takagi, Yasuhito Tanaka, Kazuo Notsumata, Eiji Mita, Hideyuki Nomura and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in Experimental and therapeutic medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01636778 (Non-randomised, Open Label, Multi-centre Phase II Study to Assess the Efficacy and Safety of SB-497115-GR in Thrombocytopenic Subjects With Chronic Hepatitis C and Compensated Liver Cirrhosis.), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01636778 phase2completednot on this map

Non-randomised, Open Label, Multi-centre Phase II Study to Assess the Efficacy and Safety of SB-497115-GR in Thrombocytopenic Subjects With Chronic Hepatitis C and Compensated Liver Cirrhosis.

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2014Enrolled45ConditionsHepatitis C, ChronicArmsSB-497115-GR
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Takumi KawaguchiDepartment of Medicine, Division of Gastroenterology, Kurume University School of Medicine, Kurume, Fukuoka 830-0011, Japan.
Atsumasa KomoriClinical Research Center, National Hospital Organization (NHO) Nagasaki Medical Center, Omura, Nagasaki 856-8562, Japan.
Kunio FujisakiKirishima Medical Center, Kirishima, Kagoshima 899-5112, Japan.
Shuhei NishiguchiDivision of Hepatobiliary and Pancreatic Disease, Hyogo College of Medicine, Nishinomiya, Hyogo 663-8501, Japan.
Michio KatoNational Hospital Organization Minami Wakayama Medical Center, Tanabe, Wakayama 646-8558, Japan.
Hitoshi TakagiDepartment of Gastroenterology, National Hospital Organization, Takasaki General Center Hospital, Takasaki, Gunma 370-0829, Japan.
Yasuhito TanakaLiver Disease Center, Nagoya University Hospital, Nagoya, Aichi 467-8602, Japan.
Kazuo NotsumataDepartment of Internal Medicine, Fukuiken Saiseikai Hospital, Fukui 918-8503, Japan.
Eiji MitaDepartment of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka 540-0006, Japan.
Hideyuki NomuraCenter for Liver Disease, Shin-kokura Hospital, Kitakyushu, Fukuoka 803-8505, Japan.
Mitsushige ShibatogeDepartment of Gastroenterology, Takamatsu Red-Cross Hospital, Takamatsu, Kagawa 760-0017, Japan.
Koichi TakaguchiDepartment of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa 760-8557, Japan.
Toshihiro HattoriNovartis Pharma KK, Tokyo 105-6333, Japan.
Michio SataResearch Center for Innovative Cancer Therapy, Kurume University School of Medicine, Fukuoka 830-0011, Japan.
Kazuhiko KoikeDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To investigate the efficacy of eltrombopag for the treatment of thrombocytopenia in patients with chronic hepatitis C, a phase II, single-arm, open-label study with a 9-week pre-antiviral phase was conducted, followed by a 48-week antiviral phase and a 24-week follow-up phase. The proportion of patients who achieved a platelet count threshold, the proportion of patients who maintained a platelet count >50,000/µl, sustained virological response (SVR) rates and safety parameters were evaluated. Of the 45 enrolled patients (median age, 59 years; median platelet count, 63,000/µl; 98% with Child-Pugh class A), 43 (96%) achieved the platelet count threshold during the pre-antiviral phase. A total of 13 patients (29%) experienced ≥1 adverse event (AE), of which headache and vomiting were the most common, and 41 patients (mostly receiving eltrombopag 12.5 mg or 25 mg) entered the antiviral phase, of which 36 (88%) maintained the platelet count threshold; no patient platelet count decreased below 25,000/µl. Nine patients (22%) achieved an SVR at the 24-week follow-up. Grade ≥3 AEs occurred in 25 patients (61%). A total of 8 serious AEs occurred in five patients (12%). No mortality, thromboembolic events (TEEs), or cataract progression were reported. Eltrombopag increased the platelet count in chronic hepatitis C virus-infected patients with cirrhosis and thrombocytopenia and enabled them to initiate and complete interferon-based antiviral therapy (NCT01636778; first submitted: July 05, 2012).

Indexed as

chronic hepatitis Cchronic liver diseaseeltrombopagethnic differencepegylated interferon/ribavirin therapythrombocytopenia

Identifiers

PMID31258695
PMCPMC6566053

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