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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic; Thrombocytopenia; Hepatitis C

Treatments: Drug: SB497115; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110799

TPL102357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 4 patient groups, including a placebo group

Arm B

Active Comparator group

Description:

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.

Treatment:

Drug: SB497115

Arm C

Active Comparator group

Description:

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.

Treatment:

Drug: SB497115

Arm D

Active Comparator group

Description:

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.

Treatment:

Drug: SB497115

Arm A

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo