SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00110799

Purpose

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

Condition	Intervention	Phase
Hepatitis C Thrombocytopenia	Drug: SB497115	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Treatment response, assessed by the proportion of subjects with a shift from baseline platelet count (20, 000 to <70,000µL) to =100,000/µL after 4 weeks of study treatment.

Secondary Outcome Measures:

Mean increase in platelet counts and markers of thrombopoiesis. Safety and tolerability, population PK, pharmacodynamics. Effect of antiviral outcome measures during and after therapy.

Estimated Enrollment:	422
Study Start Date:	April 2005

Detailed Description:

A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, when Administered as 30, 50, and 75 mg Once Daily for 12 weeks in Subjects with Chronic Hepatitis C-Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment with Pegylated Interferon and Ribavirin.

Eligibility

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

Criteria

Inclusion criteria:

Chronic low platelet count between 20,000 and <70,000/µL.
Prior liver biopsy indicating chronic hepatitis within the previous 5 years or radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding esophageal or gastric varices.

Exclusion criteria:

History of heart attack or abnormal heart function.
History of thrombosis within 1 year.
History of alcohol or drug abuse or dependence within 1 year.
Use of aspirin, aspirin-containing compounds, salicylates, antacids.
History of HIV infection or active infection with Hepatitis B or C.
Females who are pregnant.
Patients using non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110799

Show 30 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Publications indexed to this study:

McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH; TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227-36.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TPL102357
Study First Received:	May 13, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00110799
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

platelets
thrombopoietin
Hepatitis C
Hepatitis C-related thrombocytopenia

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Thrombocytopathy
Liver Diseases
Digestive System Diseases

Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009