Hepatitis C


Idenix IDX719 Phase II

Enrollment Status: Open

Purpose

This is a randomized study to evaluate the safety and efficacy of IDX719, simeprevir, and TMC647055/ritonavir boost with or without ribavirin for 12 weeks in subjects with chronic hepatitis C infection.

Inclusion Criteria

  1. Chronic hepatitis C infection with genotype 1a or 1b
  2. Treatment naïve
  3. Non-cirrhotic

Subjects will be randomized to one of two treatment groups with varying doses of IDX719.

This is an all oral, no interferon trial for hepatitis C.

Note: The cost of medications and tests related to the study will be covered by the sponsor.

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

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


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 taking antiviral medicine 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


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 person: 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 with direct-acting antiviral agents 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: Elizabeth Wu (734) 647-0236 or elizwu@med.umich.edu