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clinical research trials offered by the Liver Institute of Virginia
Dr. Shiffman is one of the world’s most recognized research physicians in the development of new treatments for viral hepatitis B, C and many other forms of liver disease. Dr. Shiffman is a regular consultant to many pharmaceutical companies and has a vast experience conducting clinical trials in patients with liver disease. This experience allows the Liver Institute medical staff the ability to offer new and more effective treatments to patients with viral hepatitis B and C, fatty liver disease and other forms of liver disorders.
The Liver Institute of Virginia helps to develop new medications for various liver disorders by participating in clinical trials with various pharmaceutical companies. Clinical trials offer patients with chronic liver disorders the opportunity to receive new and potentially highly effective medications that are not currently available by prescription.
Clinical trial for patients with Primary Biliary Cirrhosis (PBC)
- A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis (PBC)
Primary biliary cirrhosis is a chronic autoimmune disease of the liver marked by the slow progressive destruction of the small bile ducts within the liver. The purpose of this study is to determine if the investigational drug obeticholic acid (a man-made version of bile acid) will improve liver function in persons with PBC. Click here for more information.
Clinical trials for patients with Chronic Hepatitis C Virus (HCV)
- Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders
Placebo controlled, double-blind, multicenter study utilizing SOC in combination with CTS-1027 in genotype 1 chronic HCV patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as patients who failed to achieve an early virologic response (EVR) at Week 12 during previous SOC therapy. - Study on The Combination of RO5024048 And Ritonavir-Boosted Danoprevir With And Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1 who are treatment-naïve for interferons. Patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response, the assigned treatment will be continued for a further 12 weeks. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up. - Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR. - A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C. - Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C (COPE-HCV)
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment. - Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection (EMERGE)
Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease. - An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination with ABT-333 and Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to determine if the combination of the protease inhibitor ABT-450 plus the polymerase inhibitor ABT-333 with or without ribavirin can lead to SVR in patients with chronic HCV without utilizing peginterferon. - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered with Pegylated Interferon and Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection
The purpose of this study is to determine the optimal dose of the protesase inhibitor ANA-598 when combined with peginterferon and ribavirin that will lead to the highest SVR rate. - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy with GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection
The purpose of this study is to determine if the combination of a protease inhibitor and a polymerase inhibitor when combinaed with peginterferon and ribavirin will lead to higher SVR rates than the combination of a protease inhibitor peginterferon and ribavirin. - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection
The purpose of this study is to determine if the combination of a protease and polymerase inhibitor when admisnistered along with peginterferon and ribavirin can lead to high rates of SVR with a shorter duration of therapy.
Clinical trials for patients with Hepatitis B Virus
- A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon α-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B
The purpose of this study is to determine if the combination of peginterferon alfa-2a plus tenofovir can lead to highere rates of Hepatitis B virus s-antigen loss than either peginterferon alfa-2a or tenofovir alone.
Clinical trials for patients with Non Alcoholic Steatohepatitis (NASH)
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Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
Dr Shiffman is a consultant and advisor to many phamaceutical companies and medical device manufacturers. This enables Dr Shiffman to assist in the development of new treatments and tests for various liver disorders and the opportunity to bring these new medications and tests to patients at the Liver Institute of Virginia.
Dr Shiffman recieves financial compensation for serving as a consultant or advisor to the following companies:
Consultant:
Advisor:
Dr Shiffman serves on the Data Safety and Monitoring Board for the following companies:
Dr Shiffman and the Bon Secours Health System recieve grant support to conduct clinical trials from the following companies:
