Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110799
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2005-05-13
Brief Title:
SB497115 Oral Thrombopoietin Receptor Agonist Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Multi-Centre Dose-Ranging Parallel Group Phase II Study to Assess Efficacy SafetyTolerability 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
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 70000µL for Pegasys and platelet count 100000µL 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 SafetyTolerability 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None