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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. For instance, Clinical trials utilizing oral anti-viral agents to treat and cure HCV without peginterferon are currently being conducted at the Liver Institute of Virginia offices in both Richmond and Newport News.
Clinical trials for a variety of liver disease are currently being conducted at the Liver Institute of Virginia offices in both Richmond and Newport News. Patients who are interested in receiving treatment for liver disease through one of these clinical trials should contact the Liver Institute of Virginia for an appointment.
Clinical trials for patients with Chronic Hepatitis C Virus (HCV)
- Study on the Use of Oral Anti-Viral Medications to Treat and Cure Hepatitis C (HCV) - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus Infection
For the past two decades peginterferon, an interferon injection, has been the primary medication utilized to treat chronic HCV. Unfortunately, peginterferon causes many side effects which may include aches in the muscles and joints, fevers, loss of appetite, tiredness, anemia, nausea, diarrhea and suppression of the bone marrow. These side effects prevent many patients from being effectively treated and cured of HCV. Within the past two years several pharmaceutical companies have developed potent anti-viral drugs and it is now believed that HCV can be cured in just 12-24 weeks with a combination of 2 or 3 of these potent anti-viral agents without using peginterferon. - Study on the Use of Oral Anti-Viral Medications to Treat and Cure Hepatitis C (HCV) - A phase IIa, randomized, double-blind (subject and investigator blind, sponsor open) placebo-controlled trial
To evaluate the safety, tolerability and antiviral activity of oral ACH-0141625 in combination with pegylated interferon alfa-2a and ribavirin in two segments, after 28 days of dosing and, subsequently, after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1. - A Randomized, Open-Label, Multicenter 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-Naïve and Null Responder Subjects with Genotype 1 Chronic Hepatitis C Virus Infection
- A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin
This 12 week study is for subjects with chronic Genotype 2 or 3 HCV infection who are Interferon intolerant, Interferon ineligible or unwilling to take Interferon. - A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of GS-7977 In Combination with Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection
- An Open-Label Study of GS-7977 Plus Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection who Participated in Prior Studies Evaluating GS-7977
- A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 with Peginterferon Alfa 2a and Ribavirin
A 12 week study for treatment-naïve subjects with chronic Genotype 1, 4, 5, or 6 HCV infection. - A Phase 2 Randomized, Open-Label Study of GS 5885 Administered Concomitantly with GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment Naive Subjects with Chronic Genotype 1 HCV Infection
- A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 with Peginterferon Alfa 2a (PEG) and Ribavirin (RBV) in Treatment-Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
- A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection
- A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection
- 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. - A Phase II Multicenter, Randomized, Open-Label, Active-Control, Dose-Ranging Study of Interferon alfa-2b Given via Continuous Subcutaneous Infusion in Subjects with Hepatitis C Virus Genotype 1 Infection
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. - Randomized, Controlled Phase 2 a/b Study of the Efficacy and Safety Study of PEG-rIL-29 Administered in Combination with Ribavirin to Treatment-Naïve Subjects with Chronic Hepatitis C Virus
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. - A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS 5885 Alone or in Combination with GS-9451 or GS-9256 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection
- 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 Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination with Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Infection
- A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Safety and Efficacy of INX-08189 in Adjunctive Treatment with Peginterferon alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Chronically-infected HCV Genotype 2 and 3 Treatment-naïve Subjects
- 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 combined 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 administered along with peginterferon and ribavirin can lead to high rates of SVR with a shorter duration of therapy. - Collection of Blood Specimens From HCV Antibody Positive Subjects
Clinical trial 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 higher rates of Hepatitis B virus s-antigen loss than either peginterferon alfa-2a or tenofovir alone.
Clinical trial for patients with Non Alcoholic Steatohepatitis (NASH)
- 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).
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.
Dr Shiffman is a consultant and advisor to many pharmaceutical 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 receives financial compensation for serving as a consultant or advisor to many companies. He is a consultant to Exalenz, Genentech, Hoffmann LaRoche, and Human Genome Sciences. He serves as an advisor to Bayer Healthcare, Bristol-Myers Squibb, Conatus, Gilead, Globeimmune, Merck, Pfizer, Salix, and Zymogenetics.
Dr Shiffman serves on the Data Safety and Monitoring Board for Abbott and Anadys.
Dr Shiffman and the Bon Secours Health System receive grant support to conduct clinical trials from the following companies: Conatus, Bristol-Myers Squibb, Genentech, Gilead Sciences, Globeimmune, Medtronics, Mochida Pharmaceuticals, Zymogenetics, and Roche Laboratories.
