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

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, Chronic Hepatitis C Thrombocytopenia	Drug: SB497115 Other: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Eltrombopag Hepatitis A Vaccines

U.S. FDA Resources

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	April 2005
Study Completion Date:	November 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm B SB-497115-GR 30mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.	Drug: SB497115 Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. Other Name: SB497115
Active Comparator: Arm C SB-497115-GR 50mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.	Drug: SB497115 Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. Other Name: SB497115
Active Comparator: Arm D SB-497115-GR 75mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.	Drug: SB497115 Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. Other Name: SB497115
Placebo Comparator: Arm A Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.	Other: Placebo Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly 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

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

GlaxoSmithKline

More Information

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; 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:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00110799 History of Changes
Other Study ID Numbers:	TPL102357
Study First Received:	May 13, 2005
Last Updated:	May 31, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

thrombopoietin
platelets
Hepatitis C-related thrombocytopenia
Hepatitis C

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Thrombocytopenia
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Blood Platelet Disorders
Hematologic Diseases
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013