Hepatitis C


DAA Salvage B16-439: A phase 3b, multi-center, randomized, open-label, pragmatic study of glecaprevir/pibrentasvir (G/P) +/- ribavirin for GT1 subjects with chronic hepatitis C previously treated with an NS5A inhibitor + sofosbuvir therapy

Sponsor: University of Florida / AbbVie

Enrollment status: OPEN

Objective

Safety and sustained virologic response rates of glecaprevir/pibrentasvir (G/P).

Inclusion criteria

Exclusion criteria

Study design

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

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


The PRIORITIZE Study: A pragmatic, randomized study of oral regimens for hepatitis C: Transforming decision-making for patients, providers, and stakeholders

Sponsor: University of Florida / Patient-Centered Outcomes Research Institute (PCORI)

Enrollment status: OPEN

Objective

PRIORITIZE will be able to compare the effectiveness of FDA-approved medicines for HCV, side effects reported by patients, treatment adherence, and to see if patients' liver disease improves or worsens after treatment.

Inclusion criteria

Exclusion criteria

Study design

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

Contact person: Christine Patton, (734) 647-0236 or pattochr@med.umich.edu


A single-arm, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) in treatment-naïve adults with chronic hepatitis C virus (HCV) genotypes 1 – 6 infection and aspartate aminotransferase to platelet ratio index (APRI) ≤ 1

Sponsor: AbbVie

Enrollment status: CLOSED, Follow-up continuing

Objective

Safety and sustained virologic response rates of glecaprevir (GLE)/pibrentasvir (PIB)

Inclusion criteria

Exclusion criteria

Study design

Principal investigator: Hari Conjeevaram, MD, omsairam@med.umich.edu

Contact person: Elizabeth Wu, (734) 764-4048 or elizwu@med.umich.edu


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

Sponsor: University of North Carolina

Enrollment status: CLOSED, Follow-up continuing

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:

Study design

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

Contact person: Christine Patton, (734) 647-0236 or pattochr@med.umich.edu


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

Sponsor: University of Florida, University of North Carolina

Enrollment status: OPEN

Eligibility criteria

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: Christine Patton, (734) 647-0236 or pattochr@med.umich.edu


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

Sponsor: Bristol-Myers Squibb

Enrollment status: CLOSED, 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: Sravanthi Kaza, (734) 615-3853 or sravanth@med.umich.edu