Hepatitis C

University of Michigan–Peking University Joint Initiative: Predictors of hepatitis C progression

Enrollment status: Actively enrolling

Objective

To identify genetic markers that predict the progression from chronic HCV infection to cirrhosis and HCC, along with identifying and validating blood markers of liver fibrosis and early HCC.

Inclusion/exclusion criteria

  • Adults with chronic hepatitis C, not currently on antiviral treatment and no HIV coinfection.

Principal Investigator: Anna Lok, MD aslok@med.umich.edu

Contact Persons:
Sherry Fu (734) 647-3635 or sherryfu@med.umich.edu
Elizabeth Wu (734) 647-0236 or elizwu@med.umich.edu

Parallel, open-label, randomized study to evaluate the safety, pharmacokinetics, and pharmacodynamics of PSI-7977 in combination with BMS-790052 with or without ribavirin in patients who are chronically infected with hepatitis C virus genotypes 1, 2, or 3, and have not received treatment previously or who are infected with hepatitis C virus genotype 1 and have failed to respond to triple therapy with telaprevir or boceprevir plus pegylated interferon and ribavirin

Enrollment status: Closed for enrollment; patients continue to be followed.

Objective

To determine safety and effectiveness of two direct-acting antiviral agents BMS-790052 and PSI-7977 with or without ribavirin on HCV replication in patients with chronic hepatitis C, genotype 1, 2 or 3, who have not been treated previously or have failed to respond to triple therapy

Principal Investigator: Anna Lok, MD aslok@med.umich.edu

Contact persons:
Diane White (734) 763-6647 or dfwhite@med.umich.edu
Elizabeth Wu (734) 647-0236 or elizwu@med.umich.edu

Parallel, open-label, randomized, multiple-dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of BMS-790052 and BMS-650032 in combination in null responders to standard of care infected with chronic hepatitis C virus genotype 1

Enrollment status: Closed for enrollment; patients continue to be followed.

Objective

To determine safety and effectiveness of two direct-acting antiviral agents BMS-790052 and BMS-650032 with or without pegylated interferon and ribavirin on HCV replication in patients with chronic hepatitis C, genotype 1, who were null responders to pegylated interferon and ribavirin.

Inclusion/exclusion criteria

  1. HCV genotype 1
  2. Null responders to pegylated interferon and ribavirin
  3. No cirrhosis
  4. Able to tolerate interferon and ribavirin

Principal Investigator: Anna Lok, MD aslok@med.umich.edu

Contact persons:
Diane White (734),763-6647 or dfwhite@med.umich.edu
Elizabeth Wu(734) 647-0236 or elizwu@med.umich.edu

A randomized, open label, multi-center study to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) in combination with ABT-267 and/or ABT-333 with and without ribavirin (RBV) for 8, 12, or 24 weeks in treatment-naive and null responder subjects with genotype 1 chronic hepatitis C virus infection

Enrollment status: Closed for enrollment; patients continue to be followed.

Objective

To determine the safety and effectiveness of a combination of 2 or 3 hepatitis C direct-acting antiviral agents plus ritonavir boost plus ribavirin for 8, 12, or 24 weeks in patients with genotype 1 hepatitis C infection.

Inclusion/exclusion criteria

  1. HCV genotype 1
  2. No prior treatment or null responders to pegylated interferon and ribavirin
  3. No cirrhosis
  4. Able to tolerate interferon and ribavirin

Principal Investigator: Anna Lok, MD aslok@med.umich.edu

Contact persons:
Diane White (734) 763-6647 dfwhite@med.umich.edu
Sravanthi Kaza (734) 615-3853 or sravanth@med.umich.edu

Long-term follow up of patients who received asunaprevir (BMS-650032) and/or daclatasvir (BMS-790052) in previous clinical trials

Enrollment status: Actively enrolling

Objective

To determine the durability of virologic response in patients treated with asunaprevir and/or daclatasvir, assess the presence of HCV sequence variants, and characterize the long-term progression of liver disease.

Principal Investigator: Anna Lok, MD aslok@med.umich.edu

Contact person: Elizabeth Wu (734) 647-0236 or elizwu@med.umich.edu

Hepatitis C therapeutic registry and research network (HCV-TARGET) – a longitudinal, observational study

Enrollment status: Actively enrolling

Objective

To collect and study information on patients with chronic hepatitis C virus who are being treated, or who have already been treated, with telaprevir or boceprevir in a “real world” patient population to determine:

  • Effectiveness of these drugs in differing patient populations

  • Compare treatment durations in differing groups of patients

  • How best to manage side effects

  • Genetic variances in drug response

  • Drug-to-drug interactions

  • Patient education – group versus individual

  • Pharmacy usage

  • Drug resistance

Principal Investigator: Anna Lok, MD aslok@med.umich.edu

Contact person: Diane White (734) 763-6647 or dfwhite@med.umich.edu