Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Eltrombopag; Antiviral therapy
Intervention description: Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.; Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
Intervention MeSH terms: Antiviral Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peginterferon; Platelets; Ribavirin; Hepatitis C-related thrombocytopenia; Thrombocytopenia; Hepatitis C; Thrombopoietin

Summary:

      The purpose of this study is to test the safety and tolerability of eltrombopag when used to
      increase and maintain platelet count. Platelet count to be maintained at a level sufficient
      to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions,
      and to avoid permanent discontinuation of antiviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24
             Follow Up Visit in TPL103922 or TPL108390

          -  Male or female ≥18 years old

          -  Evidence of chronic HCV infection

          -  While participating in TPL103922 or TPL108390, discontinued from study drug due to
             thrombocytopenia

          -  Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin

          -  Platelet count <75,000

          -  Fertile males and females must use two forms of effective contraception during
             treatment and for 24 weeks after treatment

          -  Ability to understand and comply with the protocol requirements and instructions

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Decompensated liver disease

          -  Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag,
             or their ingredients

          -  History of clinically significant bleeding from oesophageal or gastric varices

          -  History of arterial or venous thrombosis and two or more of the following risk
             factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic
             contraception (containing estrogen); smoking; diabetes; hypercholesterolemia;
             medication for hypertension or cancer

          -  Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias
             known to involve the risk of thromboembolic events (e.g. atrial fibrillation)

          -  Evidence of hepatocellular carcinoma

          -  HIV or Hepatitis B infection

          -  Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to
             eltrombopag therapy

          -  Malignancy diagnosed or treated within the past five years. Except for localized basal
             or squamous cell carcinoma treated by local excision or malignancies that were
             adequately treated and, in the opinion of the oncologist, have an excellent chance of
             cancer-free survival.

          -  Pregnant or nursing women

          -  Men with a female partner who is pregnant

          -  History of alcohol/drug abuse or dependence within six months of the study start
             unless participating in a controlled rehabilitation programme.

          -  Treatment with an investigational drug or interferon within 30 days or 5 half-lives
             (whichever is longer) of the screening visit

          -  History or platelet clumping that prevents reliable measurement of platelet counts

          -  Evidence of portal vein thrombosis within three months of baseline visit