Listed below are the updated hepatitis C research protocols that Liver Specialists of Texas and Dr. Galati are currently conducting. The studies are in various stages of enrollment, and some may have already met the limit of how many patients we can enroll. A PDF version is available here.
New studies are being added every few weeks, so depending on your situation, and past experience with hepatitis C treatment, new opportunities may be available soon.
Currently, the ongoing studies are making use of both interferon based therapies, as well as interferon-free therapies. It is probable that the next wave of FDA approvals will be for the interferon-free protocols.
Kindly call Dee Wade at 713-794-0700 to inquire about hepatitis C research opportunities.
Research Specialists of Texas
List of Ongoing Studies
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No.
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Sponsor
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Protocol #
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Protocol Title:
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Status
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1
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Abbott
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M12-114
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A Blinded Randomized, Placebo-Controlled, Dose-Ranging study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination with Peginterferon a-2a and Ribavirin (pegINF/RBV) in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection.
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Open/Follow Up
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2
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Hoffman-La Roche, Inc.
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598-505
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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.
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Open/Follow Up
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3
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Bristol Myers S
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AI444-038
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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.
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Open/Follow Up
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4
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Bristol Myers S
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AI444-052
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A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir In combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment- Naïve Patients with Chronic Hepatitis-C
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Open/ Follow Up
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5
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Bristol Myers S
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AI443-1014
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Open-Label, Multiple Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Co administration of BMS-650032, BMS-7900052, and BMS-791325 when administered for 24 or 12 weeks in Treatment-Naïve Subjects Infected with Hepatitis C Virus Genotype 1
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Open/Enrolling
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5
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Gilead
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GS-US-337-0102
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A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir /GS-5885 Fixed-Dose Combination+ Ribavirin for 12 or 24 Weeks in Treatment-Naïve Subjects with Chronic HCV Genotype 1 Infection
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Open/ On drug Treatment/FU
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6
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Gilead
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GS-US-334-0110
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A Phase 3, Multicenter, Open Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Week
in Treatment-Naïve Subjects with Chronic Genotype 1,4, 5, or 6 HCV Infection
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Open/ Follow Up
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|
7
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Gilead
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GS-US-248-0121
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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
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Open/Follow UP
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8
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Gilead
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GS-US-248-0122 (Registry Study)
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A Long Term Follow Up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead Sponsored Trials in Subjects with Chronic HepatitisC Infection
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Open
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9
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Gilead
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GS-US-248-0123 (Registry Study)
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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
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Open
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10
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Gilead
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GS-US-256-0124
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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
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Open/ subjects completed study.
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11
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Gilead
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GS-US-196-0140
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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
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Open/ Subjects finished Study.
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12
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Gilead
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GS-US-256-0148
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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
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Open/ Follow up 2 Subjects
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13
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Gilead
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GS-US- 337-0109
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A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed Dose Combination + Ribavirin for 12 and 24 Weeks in Treatment-Experience Subjects with Chronic Genotype 1 HCV Infection
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Open/ Screening
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14
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Gilead
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P7977-1231
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A Phase III Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 weeks compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment Naïve Patients with Chronic Genotype 2or 3 HCV Infection
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Open/ Follow Up
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15
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U. Florida/U. NC
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HCV-TARGET
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Hepatitis C Therapeutic Registry and Research Network- A Longitudinal,
Observational Study
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Open/ Ready for Screening
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16
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Beckman Coulter
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HCV-01-11
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Multicenter, Prospective Evaluation of the Beckman Coulter DxN-HCV Viral Load Assay as an Aid in the Management of HCV- Infected Individual Undergoing Antiviral
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Open/Ready for Screening
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|
17
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Merck
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5172-003
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A Dose Ranging Study to Test the Safety, Tolerability and Effectiveness of Different Doses of MK-5172 When Given with Peginterferon alfa-2b and Ribavirin in Patients with Hepatitis C Virus Infection
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Open/ Follow Up
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|
18
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Merck
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7009-028
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A Phase 2 Open Label Study of MK 7009 Administered Concomitantly with Pegylated Interferon Alfa 2a and Ribavirin to Patients with Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials
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Open/ Follow Up
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19
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Merck
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5172-017 (Roll Over)
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A Long Term Follow Up Study to Evaluate the Durability of Virologic Response and /or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have been Previously Treated with MK5172 in a Prior Clinical Trial
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IRB Approved. Sponsor Site Activation.
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20
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Novartis
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CDEB025A2301
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A Randomized Double Blind,Placebo- Controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination with Peginterferon alpha 2a (PEG-IFN) and Ribavirin in hepatitis C Genotype 1 treatment naïve patients.
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Open/ Follow Up
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21
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Novartis
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CDEB025A2312 (Roll Over)
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A Multi-Centre 3 Year Follow Up Study to assess the Durability of Sustained Virologic response in Alisporivir treated Chronic Hepatitis C patients
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Open/ Follow Up
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22
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Novartis
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CDEB025A2313 (Roll Over)
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A Multi-Centre 3 Year follow up study to assess the viral activity in patients Who failed to achieve sustained virologic response in Novartis sponsored Alisporivir –studies for chronic Hepatitis C patients
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Open
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23
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Schering-Plough
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P05063
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Term Follow Up of Subjects in a Phase 1,2,or 3 Clinical Trial in Which Boceprevir or Narlaprevir was administer red for the treatment of Chronic Hepatitis C
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Open/ Follow Up
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24
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Schering-Plough
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P05514
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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
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Open/ Subjects Completed study
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25
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Tibotec
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TMC435-TiD16-C213
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A Phase III Open Label Trial of TMC435 In Combination with Peginterferon And Ribavirin for HCV Genotype 1 infected Subjects who Participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007) or who received short term (up to 14 days) direct acting antiviral treatment for hepatitis C infection in a selected Jansen R&D Ireland-Sponsored phase I Study.
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Open
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26
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Tibotec
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TMC435-TidP16-C216
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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.
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Open/ Subjects Completed study
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27
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Tibotec
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TMC435HPC3007
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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.
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Open/ Subjects Completed study
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28
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Tibotec
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VX-950-C211
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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.
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Open/Subjects Completed Study
Close out visit on 1/31/13
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29
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Salix Pharmaceuticals, Inc.
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RFHE4044
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A Multicenter, Randomized, Open, Label, Active Controlled, Trial To Evaluate The Safety And Efficacy If Rifaximin 550 MG With and Without Lactulose In Subjects With A History Of Recurrent Overt Hepatic Encephalopathy
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IRB Approved
Waiting Site Activation.
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As of 1/18/13