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)

INTERVENTION:

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: mg milligram(s) Concentration type: equal Concentration number: 25‐ 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: mg milligram(s) Concentration type: equal Concentration number: 50‐ 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: mg milligram(s) Concentration type: equal Concentration number: 75‐ 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: mg milligram(s) Concentration type: equal Concentration number: 100‐

CONDITION:

Thrombocytopenic subjects with hepatitis C viral infection (HCV) ; MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis

C PRIMARY OUTCOME:

Main Objective: To evaluate the safety and tolerability of open‐label eltrombopag when administered once daily. 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. Secondary Objective: • To evaluate platelet counts before and during antiviral therapy.; • To evaluate maintenance of antiviral therapy.; • To evaluate achievement of antiviral treatment milestones.;

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 th