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

Condition(s) targeted: Hepatitis C; Thrombocytopaenia

Intervention: Eltrombopag (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

Official title: 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)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety and tolerability by evaluation of adverse events, laboratory test abnormalities, eye examinations, and clinical examination and observation

Secondary outcome:

Platelet counts before and during antiviral therapy

Maintenance of antiviral therapy

Acheivement of antiviral treatment milestones

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Praha 4 140 21, Czech Republic; Recruiting
Jan Sperl, Principal Investigator

GSK Investigational Site, Marseille Cedex 08 13285, France; Recruiting
Marc Bourliere, Principal Investigator

GSK Investigational Site, Nice cedex 3 06202, France; Not yet recruiting
Albert Tran, Principal Investigator

GSK Investigational Site, Pessac Cedex 33604, France; Not yet recruiting
Victor De Ledinghen, Principal Investigator

GSK Investigational Site, Berlin 10969, Germany; Recruiting
Thomas Berg, Principal Investigator

GSK Investigational Site, Athens 10676, Greece; Recruiting
Dimitrios Karamanolis, Principal Investigator

GSK Investigational Site, San Juan 00909-1711, Puerto Rico; Not yet recruiting
Maribel Rodriguez-Torres, Principal Investigator

GSK Investigational Site, Madrid 28029, Spain; Recruiting
Javier Garcia Samaniego, Principal Investigator

GSK Investigational Site, Valencia 46010, Spain; Recruiting
Moises Diago, Principal Investigator

GSK Investigational Site, Freiburg, Baden-Wuerttemberg 79106, Germany; Not yet recruiting
Robert Thimme, Principal Investigator

GSK Investigational Site, Ulm, Baden-Wuerttemberg 89081, Germany; Recruiting
Dietmar Klass, Principal Investigator

GSK Investigational Site, New Haven, Connecticut 06520, United States; Not yet recruiting
Joseph K Lim, Principal Investigator

GSK Investigational Site, Bologna, Emilia-Romagna 40138, Italy; Recruiting
Pietro Andreone, Principal Investigator

GSK Investigational Site, Honolulu, Hawaii 96817, United States; Recruiting
Naoky Tsai, Principal Investigator

GSK Investigational Site, Genova, Liguria 16132, Italy; Recruiting
Vincenzo Savarino, Principal Investigator

GSK Investigational Site, Camperdown, New South Wales 2050, Australia; Recruiting
Simone Strasser, Principal Investigator

GSK Investigational Site, Garran - ACT, New South Wales 2605, Australia; Recruiting
Geoffrey Farrell, Principal Investigator

GSK Investigational Site, Randwick, New South Wales 2031, Australia; Recruiting
Stephen Riordan, Principal Investigator

GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen 40225, Germany; Not yet recruiting
Andreas Erhardt, Principal Investigator

GSK Investigational Site, Montreal, Quebec H2X 3J4, Canada; Not yet recruiting
Marc Bilodeau, Principal Investigator

GSK Investigational Site, Nashville, Tennessee 37212, United States; Not yet recruiting
Michael Porayko, Principal Investigator

Starting date: September 2009
Last updated: July 1, 2010