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Hepatitis C

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The Patient-Reported Outcomes Project of HCV-TARGET ("PROP UP")

 

Enrollment status: Actively enrolling

 

Objective

To collect important information directly from patients about their experiences with undergoing treatment for chronic hepatitis C. Patients will be asked to complete surveys before, during and after hepatitis C treatment. With the information collected on these surveys, the researchers can better answer the following questions:

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:

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

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


POLARIS-1

 

A phase 3, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of sofosbuvir/velpatasvir/GS-9857 fixed-dose combination for 12 weeks in direct-acting antiviral-experienced subjects with chronic HCV infection

Sponsor: Gilead

Enrollment status: Closed for enrollment, follow-up continuing

 

Objective

Safety and sustained virologic response rates of this three-drug combination

Inclusion criteria

Exclusion criteria

Study design

Note: study medications and tests associated with the study will be covered by sponsor.

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

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


POLARIS-2

 

A phase 3, global, multicenter, randomized, open label study to investigate the safety and efficacy of sofosbuvir/velpatasvir/GS-9857 fixed-dose combination for 8 weeks compared to sofosbuvir/velpatasvir for 12 weeks in direct-acting antiviral-naive subjects with chronic HCV infection

Sponsor: Gilead

Enrollment status: Closed for enrollment, follow-up continuing

 

Objective

Safety and sustained virologic response rates of 8 weeks of a three-drug combination compared to 12 weeks of a two-drug combination

Inclusion criteria

Exclusion criteria

Study design

Note: study medications and tests associated with the study will be covered by sponsor

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

Contact person: Sravanthi Kaza: (734) 615-3853 or sravanth@med.umich.edu


POLARIS-3

 

A phase 3, global, multicenter, randomized, open-label study to investigate the safety and efficacy of sofosbuvir/velpatasvir/GS-9857 fixed-dose combination for 8 weeks and sofosbuvir/velpatasvir for 12 weeks in subjects with chronic genotype 3 HCV infection and cirrhosis

Sponsor: Gilead

Enrollment status: Closed for enrollment, follow-up continuing

 

Objective

Safety and sustained virologic response rates of two-drug combination for 12 weeks vs. three-drug

Inclusion criteria

Exclusion criteria

Study design

Note: Study medications and tests associated with the study will be covered by the sponsor.

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

Contact person: Sravanthi Kaza: (734) 615-3853 or sravanth@med.umich.edu


POLARIS-4

 

A phase 3, global, multicenter, randomized, open-label study to investigate the safety and efficacy of sofosbuvir/velpatasvir/GS-9857 fixed-dose combination for 12 weeks and sofosbuvir/velpatasvir for 12 weeks in direct-acting antiviral-experienced subjects with chronic HCV infection who have not received an NS5A inhibitor

Sponsor: Gilead

Enrollment status: Closed for enrollment, follow-up continuing

 

Objective

Safety and sustained virologic response rates of 12 weeks of a three-drug combination compared to 12 weeks of a two-drug combination

Inclusion criteria

Exclusion criteria

Study design

Note: Study medications and tests associated with 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

Additional funding from the Bristol-Myers Squibb Foundation

Enrollment status: Closed for enrollment, follow-up continuing

 

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

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


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

 

Enrollment status: Closed for enrollment, follow-up continuing

 

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