NCT01636778

Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients

Non-randomised, Open Label, Multi-centre Phase II Study to Assess the Efficacy and Safety of SB-497115-GR in Thrombocytopenic Subjects With Chronic Hepatitis C and Compensated Liver Cirrhosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count \<80,000 /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate to a higher rate of sustained viral response.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	SB-497115-GR	TPO receptor agonist to increase platelet count

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-01
• Completion: 2014-11-01
• First posted: 2012-07-10
• Last updated: 2016-03-01
• Results posted: 2015-02-23

Locations

16 sites across 1 country: Japan