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Ertan Digestive Disease Center Clinical Research Protocols

Gastroenterology and Hepatology

Working together with the Ertan Digestive Disease Center/The University of Texas Health Science Center at Houston (UT-Health) Medical School, investigators at the GI Center for Excellence are conducting innovative and ground breaking treatments for a variety of gastrointestinal and liver diseases.

Listed below is a sample of some of the specialties we are currently doing active clinical research protocols.  Many of these are collaboration with pharmaceutical companies to bring ideas and science to our patient management.

  • Crohn's Disease
  • Barrett's Esophagus
  • Ulcerative Colitis
  • Irritable Bowel Disease
  • Chronic Liver Disease
  • Hepatitis C
  • Hepatitis B
  • Liver Cancer

Please feel free to contact us at: gireasearch@uth.tmc.edu or (713) 500-6669 for more information.

With the vast knowledge and leading investigators here are the Ertan Digestive Disease Center at Memorial Hermann Houston and UT-Health, these studies are always growing and progressive.

Currently Enrolling:

For detailed information, click here.

1. A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2c/ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects

2. A 2-Part, Open-Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected with Genotype 1 Hepatitis C Virus Following Liver Transplantation.

3. 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.

4. An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy.

5. A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 2b Study to Compare the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2, Ribavirin) to Triple Therapy (with VX-222-Placebo) in subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis.

6. 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.

7. A Phase2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study with an Open-Label Extension to Evaluate with Efficacy, Safety, and Pharmacokinetics of E5501 in Subjects with Chronic Hepatitis C Virus-Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment.

8. Terlipressin, Lucassin® IK-4001-HRS-301 A Multi-center, randomized, placebo-controlled, double-blind study to confirm the reversal of Hepatorenal Syndrome Type I with Lucassin® (Terlipressin) (Reverse Trial) Formally Orphan Therapeutics.

9. A Multi-Center, Placebo-Controlled, Randomized Pilot Study of the Effect of Sorafenib on Portal Pressure in Patients with Cirrhosis, Significant Portal Hypertension and Hepatocellular Carcinoma Treated with Ablative Therapy and/or Transarterial Chemoembolization.

10. A Multi-Center, Randomized Pilot Study of the Effect of Sorafenib Dosing Schedule on Tolerability and Drug Delivery.

11. "Protocol C87075 Amendment 1 "SECURE": A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease".

12. ABBOTT "A 5-Year Registry Study of Humira (Adalimumab) in Patients With Moderately to Severely Active Crohn's Disease".

13. JANSENN UNITI3001 "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Diseaese Who Have Failed or Are Intolerant to TNF Antagonist Therapy".

14. JANSENN UNITI 3002 "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severly Active Crohn's Disease".

15. JANSENN IMUNITI 3003 "A Phase 3, Randomized, Double-blind,   Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease".

16. SANTARUS CONTRIBUTE: "A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild, or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen".

17. PFIZER"a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis".

18. PFIZER "A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral Cp-690, 550 As A Maintenance Therapy In Subjects With Ulcerative Colitis".

19. PFIZER"A Multi-Center, Open-Label Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis".

20. Rifaximin Treatment of Rome II Established Irritable Bowel Syndrome (IBS) A Pilot Study to Evaluate a Maintenance Dosing Regimen

21. A Radomized, Double -Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Exteneded-release Tablets as Add-on Therapy in Patients with Active Mild or Background Oral 5-ASA Regimen.

22. A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 MG TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D).

23. Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis; A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606in Subjects with Acute, Mild to Moderate Ulcerative Colitis.

24. A Phase 3b. Randomized, Double-Blind, Placebo-Controlled Trial Evaluation Response Guided Theraphy with GS 5885 Alone or in Combination with GS-9451 with Pefinterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

25. 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.         

26. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered with Pegylated Interferon and Ribovirin in Genotype 1 Patients with Chronic Hepatitis C Infection.

27. A Long-term Follow-U Study of Subjects Who Participated in a Clinical Trial in which BMS-914143 was Administered for the Treatment of Chronic Hepatitis C.

28. ACID REFLUX (TIF PROCEDURE): This TIF (Transoral Incisionless Fundoplication, Esophy X) is a national multicenter and randomized nonsurgical study and reconstructs the antireflux valve using a device called the Esophy X.

29. INTRAGASTRIC BALLOON PROCEDURE: This procedure is a national        multicenter nonsurgical endoscopic procedure for selected patients with morbid   obesity.