Two major research interests are viral hepatitis and autoimmune liver disease (non transplant).

Viral Hepatitis

Hepatitis C:

Current Peer Reviewed Funded Studies:

• National Research Training Program in Hepatitis C (CI): 2009-2015


• FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy (Funded by PSI - CI)


• Effect of Diet and Exercise on Insulin Resistance in Obese Patients with Chronic Hepatitis C (Funded by CIHR - PI)


• The Molecular Genetics of Hepatitis C Viral Infection: Defining Novel Therapeutic and Pathogenic Mechanisms. (Funded by CIHR - CI)

Investigator Initiated Clinical Trials:

• Extended Therapy in Genotype 3 Infected Patients Who Do Not Achieve a Treatment Response at Week 4 (RVR) But Do Achieve An Early Virologic Response (Funded by Schering Plough)

Industry Funded Clinical Trials:

• Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination with Pegasys and Copegus in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response


• Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination with Pegasys and Copegus in Treatment-Naove Subjects with Genotype 1 Chronic Hepatitis C


• Randomised, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects with Hepatitis C Virus Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a/b Plus Ribavirin)


• Long-Term Follow-up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C


• Phase 3 Safety and Efficacy Study of Boceprevir in Subjects with Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment with Peginterferon/Ribavirin


• Phase 3 Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects with Chronic Hepatitis C Genotype 1


• Antiviral Effect, Safety and Pharmacokinetics of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-Naove Patients for 24 Weeks as Combination Therapy with Pegylated Interferon-Alfa 2a and Ribavirin (Double-Blinded, Randomised, Placebo-Controlled, Phase II)


• Randomized, Partially-Blind Study to Evaluate Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor R05190591 in Combination with Pegasys and Copegus for 12 or 24 Weeks, Versus Treatment with Pegasys and Copegus Alone, in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 Virus Infection


• Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 As Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Genotype 1 Hepatitis C Infected Subjects


• Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 As Part of a Treatment Regimen Including PegIFN Alfa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed to Respond or Relapsed Following At Least One Course of PegIFN Alfa-2a/b and RBV Therapy


• Three-Year, Virology Follow-Up Study in Subjects Previously Treated with Telaprevir in Select Clinical Studies


• Phase II Study of the Safety and Efficacy of Narlaprevir (SCH 900518) In Combination with Peginterferon and Ribavirin in Previously Untreated Subjects with Genotype 1 Chronic Hepatitis C (pending review)


• Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of 48 Weeks of GS-9190 in Combination with Pegasys and Copegus in Previously Untreated Subjects with Genotype 1 Chronic Hepatitis C Virus Infection (pending review)

Hepatitis B:

Peer Reviewed Funded Studies:

• Participating Site in National Institutes of Health in Hepatitis B Clinical Network Consortium (PI)

Industry Funded Clinical Trials:

• Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF vs Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B


• Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF vs Adefovir Dipivoxil for the Treatment of Pre-Core Mutant Chronic Hepatitis B


• Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults who are Treatment-Naove to Nucleosides and Nucleotides: The BE-LOW Study


• A Phase 3b, Randomized, Double-blind, Double Dummy Study Evaluation the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination therapy in Subjects With Chronic Hepatitis B who are Resistant to Lamivudine

Autoimmune Liver Disease

Peer Reviewed Funded Studies:

• Molecular Dissection of Primary Biliary Cirrhosis (Funded by CIHR - PI)

Industry Funded Clinical Trials:

• Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO, UDCA) in Patients with Primary Biliary Cirrhosis (CI)


• Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO., UDCA) in Patients With Primary Biliary Cirrhosis - Long Term Safety Extension (LTSE) (CI)


• Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis (CI)

Abbreviations
CIHR - Canadian Institute Health Research
CLF - Canadian Liver Foundation
PSI - Physician Services Incorporated

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