Thrombocytopenic subjects with hepatitis C viral infection (HCV) MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: m
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, =18 years of age. 2. Evidence of chronic HCV infection (quantifiable HCV RNA, lower limit of detection of 50 IU/ml). 3. Subjects must be previous participants of TPL103922 (ENABLE 1) or TPL108390 (ENABLE 2) and successfully initiated antiviral treatment in those studies. 4. Subjects must have permanently discontinued all investigational products for ENABLE 1 or 2 within 12 weeks from randomisation in ENABLE 1 or 2 due to reasons of thrombocytopenia. Subjects who continued antiviral therapy beyond 6 weeks must have had some degree of thrombocytopenia during this time, defined as having at least a 50% dose reduction of pegylated IFN (for reasons of thrombocytopenia) for a minimum period of 4 weeks. 5. All subjects must have completed the final 6 month (24 week) SVR and ocular follow-up assessments in ENABLE 1 or ENABLE 2. 6. Subjects who, in the opinion of the investigator, are appropriate candidates for retreatment with peginterferon alfa and ribavirin combination antiviral therapy. 7. A platelet count of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Decompensated liver disease. 2. Known hypersensitivity, intolerance or allergy to interferon, ribavirin, eltrombopag or any of their ingredients. 3. Documented history of clinically significant bleeding from oesophageal or gastric varices. 4. Any prior history of arterial or venous thrombosis AND ? two of the following risk factors: • hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc) • hormone replacement therapy • systemic contraception (containing estrogen) • smoking • diabetes • hypercholesterolemia • medication for hypertension or cancer 5. Pre-existing cardiac disease (congestive heart failure Grade III/IV), (See Appendix 2: New York Heart Association (NYHA) Functional Classification), or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation). 6. Evidence of hepatocellular carcinoma by ultrasound, CT or MR scan. 7. Subjects with Human Immunodeficiency Virus (HIV) or active Hepatitis B Virus (HBV) infection (i.e., is positive for Hepatitis B Surface Antigen (HBsAg)). 8. Therapy with any anti-neoplastic or immuno-modulatory treatment ?6 months prior to the first dose of eltrombopag. Exception: Physiologic doses of steroids or short courses of steroids (e.g., steroid taper for exacerbation of asthma) are not excluded. 9. Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma of the skin treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival. 10. Pregnant or nursing women. 11. Males with a female partner who is pregnant. 12. History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme). 13. Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit. 14. History of platelet clumping that prevents reliable measurement of platelet counts. 15. Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of open-label eltrombopag when administered once daily.;Secondary Objective: • To evaluate platelet counts before and during antiviral therapy. • To evaluate maintenance of antiviral therapy. • To evaluate achievement of antiviral treatment milestones. ;Primary end point(s): Assessment of safety and tolerability of eltrombopag as measured by the nature and frequency of adverse events, laboratory abnormalities, ocular examinations and clinical monitoring/observation. | — |
Countries
France, Germany, Greece, Italy, Slovakia, Spain, United Kingdom
Outcome results
None listed