Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390 (ENABLE-ALL)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Antiviral therapy; Drug: Eltrombopag

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996216

108392

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Open-label eltrombopag

Experimental group

Description:

Open-label eltrombopag with dose titrations to support adequate platelet counts.

Treatment:

Drug: Antiviral therapy

Drug: Eltrombopag