Clinical trial NCT00110799: SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Hepatitis C
Thrombocytopenia
Keywords: thrombopoietin
platelets
Hepatitis C-related thrombocytopenia
Hepatitis C
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-05-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean increase in platelet counts and markers of thrombopoiesis. Safety and tolerability, population PK, pharmacodynamics. Effect of antiviral outcome measures during and after therapy.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Fairfax
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Clermont Ferrand Cédex 1
country: France
facility: GSK Investigational Site
city: Clichy Cedex
country: France
facility: GSK Investigational Site
city: Lyon Cedex 02
country: France
facility: GSK Investigational Site
city: Lyon
country: France
facility: GSK Investigational Site
city: Marseille Cedex 08
country: France
facility: GSK Investigational Site
city: Nice Cedex 03
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Pessac Cedex
country: France
facility: GSK Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: GSK Investigational Site
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Homburg
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
state: Gloucestershire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1056/NEJMoa073255.