Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease - Full Text View

Purpose

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

Condition	Intervention	Phase
Thrombocytopenia Hepatitis C	Drug: eltrombopag	Phase III

Genetics Home Reference related topics:

Bleeding Disorders

MedlinePlus related topics:

Hepatitis Hepatitis C Liver Diseases

ChemIDplus related topics:

Ribavirin Peginterferon Alfa-2a Interferon alfa-2b Interferons Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomised, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

SVR rate defined as percentage of subjects with non-detectable HCV-RNA at 24 weeks post-completion of the planned treatment period (i.e., Week 48 for genotype 2/3 or Week 72 for non-genotype 2/3)

Secondary Outcome Measures:

Proportion of subjects with a shift in platelet count from <75,000/µL to >/=90,000/µL. Adverse events, laboratory abnormalities, ocular examinations, 12-lead ECGs, and clinical monitoring/observation.

Estimated Enrollment:	750
Study Start Date:	October 2007
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects, aged >/=18 years.
Chronic HCV infection (i.e. detectable HCV RNA).
Suitable for treatment with peginterferon alfa-2a and ribavirin combination antiviral therapy.
An entry platelet count of <75,000/µL
Haemoglobin concentration >/=11.0g/dL for men or >/=10.0g/dL for women.
Absolute neutrophil count >/=750/mm3 and no history of infections associated with neutropenia.

Exclusion Criteria:

Non-responders to previous treatment with peginterferon and ribavirin who failed to achieve a SVR for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with peginterferon and ribavirin.
Decompensated liver disease, e.g. Child-Turcotte-Pugh score >6, or history of ascites or hepatic encephalopathy or current evidence of ascites.
Infection with Human Immunodeficiency Virus (HIV) or active Hepatitis B Virus (HBV) infection.
History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme).
Pregnant or nursing women, or males with a female partner who is pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516321

Show 191 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	TPL103922
First Received:	August 13, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00516321
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

thrombopoietin

hepatitis C

Hepatitis C-related thrombocytopenia

platelets

peginterferon alfa-2a

ribavirin

Study placed in the following topic categories:

Hepatitis

Thrombocytopathy

Liver Diseases

Thrombocytopenia

Blood Platelet Disorders

Interferons

Ribavirin

Benzocaine

Peginterferon alfa-2a

Hepatitis, Viral, Human

Hepatitis C

Interferon Alfa-2b

Additional relevant MeSH terms:

Virus Diseases

Anti-Infective Agents

RNA Virus Infections

Digestive System Diseases

Flaviviridae Infections

Hematologic Diseases

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00516321