Last updated: 11/04/2018 12:52:42
SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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:
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
Interventions:
Drug: SB497115
Other: Placebo
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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; TPL 102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated hepatitis C. N Engl J Med. 2007;357(22) :227-36.
Zhang JP, Thapar M, Farrell C, Wire MB.Modeling and Simulation Support Eltrombopag Dosing in Thrombocytopenic Patients with Chronic HCV infection.Pharm Res.2015;32(6):2015-2028
Medical condition
Hepatitis C, Chronic, Thrombocytopenia
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
April 2005 to October 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- History of heart attack or abnormal heart function.
- History of thrombosis within 1 year.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63104
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Bristol, Gloucestershire, United Kingdom, BS2 8HW
Status
Study Complete
Location
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80262
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78215
Status
Study Complete
Location
GSK Investigational Site
Clermont Ferrand Cédex 1, France, 63058
Status
Study Complete
Location
GSK Investigational Site
Fairfax, Virginia, United States, 22031
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-20-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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