ENABLE ALL - Eltrombopag in Thrombocytopenic Patients with Hepatitis C

• Research type

  Research Study

• Full title

  TPL108392: An open-label, multi-centre rollover study to assess the safety and efficacy of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin). ENABLE-ALL (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C Related Liver DiseasE – All Subjects Withdrawing From ENABLE 1 and 2 through Lack of Response).

• IRAS ID

  24074

• Contact name

  Geoffrey Dusheiko

• Sponsor organisation

  GlaxoSmithKline UK Limited

• Eudract number

  2008-000660-17

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  ENABLE ALL (TPL108392) is designed for participants who withdrew from the ENABLE 1 (TPL103922) study due to lack of response. The ENABLE 1 and ENABLE ALL studies assess the efficacy and safety of eltrombopag in thrombocytopenic patients with hepatitis C virus (HCV) infection who are otherwise eligible to start antiviral therapy with peginterferon alfa-2a plus ribavirin. The study is split into 2 parts, in the first part participants are treated with eltrombopag to raise their platelets to a level where antiviral therapy can be initiated. The participants will then move into part 2 of the study and receive anti viral treatment for up to 48 weeks in conjunction with eltrombopag. A small number of hepatology departments at UK hospitals are recruiting patients into these studies.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/53

• Date of REC Opinion

  5 Aug 2009

• REC opinion

  Further Information Favourable Opinion