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Center for Liver Disease & Transplantation

Clinical Trials

Following is a list of the clinical trials currently underway at the Methodist Center for Liver Disease and Transplantation. For explanations of some of the terms used in the following list, scroll down to the Clinical Trials Glossary. To find out more about specific trials, please send an email to liverresearch@tmhs.org.

  1. A Multi-Center, Open Label Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects with A History of Hepatic Encephalopathy. Salix
  2. A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1 (ACHIEVE-1)-. Human Genome Sciences
  3. Long-Term Follow-up of Subjects in a Phase 2 or 3 Clinical Trial in Which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C. Schering-Plough/Merck
  4. A Phase 3b, Randomized, Double-Blind, Double Dummy Study Evaluating the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy versus Emtriciabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects with Chronic Hepatitis B who are resistant to Lamivudine. Gilead
  5. A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD). Eisai
  6. A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects with Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment with Peginterferon/Ribavirin. Schering-Plough/Merck
  7. A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects with Chronic Hepatitis C Genotype 1. Schering-Plough/Merck
  8. A Randomized, Double-Blind, Placebo-controlled, Phase III trial of 2 regimens of Telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) in subjects with Chronic genotype 1 Hepatitis C infection who failed prior pegylated interferon plus Ribavirin treatment. Tibotec
  9. A Single-Arm Study to Provide Boceprevir Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies. Schering-Plough/Merck
  10. A Phase 2 Study of SCH 900518 in Previously Untreated Subjects with Genotype 1 Chronic Hepatitis C. Schering- Plough/Merck
  11. A Phase 3 Safety and Efficacy Study of Boceprevir in Combination with Peginterferon Alfa-2a and Ribavirin in Subjects with Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment with Peginterferon/Ribavirin. Schering-Plough/Merck
  12. A 52 week, open-label, single-arm, multicenter study of Tyzeka™(telbivudine) in nucleos(t)ide-naïve subjects of Black/African American and/or Hispanic/Latino origin with compensated chronic hepatitis B virus (HBV) infection. Gilead
  13. A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected with Genotype 1 Chronic Hepatitis C. Idenix
  14. Boceprevir/Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naïve Subjects: A Comparison of Erythropoietin Versus Ribavirin Dose Reduction for the Management of Anemia. Schering-Plough/Merck
  15. A randomized, open-label, Phase 3 study of telaprevir administered twice daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus infection. Substudy – A substudy to investigate telaprevir-related rash in a selected number of subjects enrolled in Study VX-950-C211. Tbotec
  16. A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 versus placebo as part of a treatment regimen including peginterferon α-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon α-2b (PegIntron®) and ribavirin (Rebetol®) in treatment-naïve, genotype 1, hepatitis C-infected subjects. Tibotec
  17. A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in hepatitis C, genotype 1 infected subjects who relapsed after previous interferon-based therapy. Tibotec
  18. A multicentre, randomized, double-blind, placebo-controlled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2 plus ribavirin treatment-non-responders. Novartis
  19. A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNα2a plus ribavirin) in treatment naïve hepatitis C genotype 2 and 3 patients. Novartis
  20. A Phase II Multicenter, Randomize, 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. Medtronics
  21. An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) for subjects from the control group of the VX 950 TiDP24 C216 trial who failed therapy for virologic reasons. Tibotec
  22. A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment with Pegylated Interferon and Ribavirin. Idera
  23. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of Safety, Efficacy, and Pharmacokinetics of ANA598 Administered with Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients with Chronic Hepatitis C Infection. Anadys
  24. A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Experienced Patients with Chronic Genotype 1 Hepatitis C Virus Infection. Merck
  25. 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. Gilead
  26. 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. Anadys
  27. Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of Pegylated Interferon Plus Ribavirin With or Without CTS-1027 in HCV Null-Responders. Conatus
  28. 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 Gilead
  29. 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. Gilead
  30. 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. Gilead
  31. 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. Gilead
  32. A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 Hepatitis C Virus Infection. Merck
  33. A Randomized, double-blind, placebo-controlled trial of the efficacy and Safety of DEB025/Alisporovir in combination with standard of care in Hepatitis C genotype1 treatment-naïve patients. Novartis
  34. Open-Label, Single Arm Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos, and White-Caucasians with Chronic Hepatitis C Genotype 1 Infection. Bristol-Meyers Squibb

Clinical Trials Glossary

Active Controlled: Subjects are randomly assigned to either a recognized effective treatment or the study drug.

Dose Escalation: The amount of the drug is either periodically increased or increased with each new trial group that is added, so that researchers can determine how the drug is tolerated in patients.

Double Blind: Neither the researchers nor the patients know which patients are receiving the experimental drug and which are receiving a placebo or a different drug.

Multi-center: The trial is being conducted at several geographically separate sites.

Open Label: Both the researcher and the patient know the full details of the treatment being administered.

Phase 1: Initial studies to determine metabolism and pharmacologic action of the drug, side effects with increasing doses, and early evidence of effectiveness.

Phase 2: Controlled studies to evaluate the drug’s effectiveness for particular indications in patients with the condition under study, and to determine the common short-term side effects and risks.

Phase 3: Expanded controlled and uncontrolled trials to evaluate the overall benefit-risk relationship of the drug and to provide a basis for physician labeling.

Placebo Controlled: An inactive substance (placebo) is given to one group of participants, while the drug being tested is given to another group.

Randomized: Participants are randomly assigned to one of two or more treatment groups within the trial.

To find out more about research at the Methodist Center for Liver Disease and Transplantation, send an email to liverresearch@tmhs.org.