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Research


What is Clinical Research?

Clinical research is a way for doctors and scientists to answer questions about healthcare. Research can find better ways to prevent, diagnose or treat diseases and disorders. There are many kinds of clinical research. For example, some studies test new medicines or devices. Other studies use interviews to learn about health problems.

What is a Protocol?

A protocol is a written plan that describes the goal of a research study and how the study will be conducted. For example, it describes the type of people needed to take part in the study. The protocol also outlines any procedures the participants will undergo.

What is a Clinical Research?

Drugs and medical devices must be proven safe and effective in people before the U.S. Food and Drug Administration (FDA) will approve them for general use. A clinical trial is a study that tests a drug or medical device to see if it is safe and effective for treating people. The government has strict rules for clinical trials. These rules help to ensure that study participants are safe.

What are clinical trial "phases"?

Clinical trials that test drugs go through four stages or "phases." A Phase I clinical trial is the first time an experimental drug is tested in humans. It is usually given to a small group of healthy participants. The purpose of a Phase I study is to gather information on the drug's safety.

A Phase II clinical trial is usually the second stage of testing a new drug in humans. This phase commonly involves 100 to 300 participants. The participants usually have the disease for which the experimental drug is being tested. The purpose of this phase is to gather additional information on safety and to see how effective the drug is.

A Phase III clinical trial commonly involves 1,000 to 3,000 participants that have the disease for which the experimental drug is being tested. This phase usually compares the experimental drug to the current approved treatment for the disease. Side effects and effectiveness are also monitored during a Phase III trial.

A Phase IV clinical trial is done after the drug has been approved for marketing. This stage of testing usually compares the drug to a competing drug or looks at the drug in new types of patients. Long-term side effects of the drug are also monitored in this phase.

What types of study participants are needed?

Many types of people are needed to participate in research studies. Some studies need healthy persons. Other studies need persons with certain health problems. Persons of all ages and from all ethnic groups are needed. Why do people participate in research studies?

Every study is different, and the reasons people participate are different. Some reasons people take part in a study are:

  • To help others

  • To possibly improve their own health

  • To help advance science

  • To gain access to treatments before they become widely available

  • To access treatment options that might not be available outside of the research

What are the risks of participating in a research study?

The risks for each study are different. Some possible risks of taking part in a research study are:

  • The experimental treatment may not be as good as or better than the standard treatment.

  • If an experimental treatment is better than the standard treatment, it may not work for everyone.

  • New drugs and treatments may have side effects that are unknown to the researchers.

How are study participants protected?

  • The Federal government has rules to protect study participants.

  • All research studies in the United States must be approved and monitored by a group of people called an Institutional Review Board (IRB). The IRB is made up of scientists, doctors and community people. They review studies to help make sure that study participants will be assafe as possible.

  • Participants must be given complete information about the research study. They must also give their informed consent before taking part in the study.

These methods of protection do not eliminate all possibility of risk. They do help to ensure study participants will be as safe as possible. What is informed consent?

Before taking part in a study, each person will get a consent form that contains important written information about the study. It is important to read and understand the information in this form. The researcher or member of the research team will also talk to the person about the information contained in the form. The person should be sure all of his or her questions are answered before signing the consent form. A signed consent form is not a contract-a participant can leave a study at any time.

What questions should I ask before deciding to participate in a research study?

Before you decide to participate, you should ask as many questions as you need to in order to be sure you understand the study. Some questions you might want to ask are:

  • What is the purpose of the study?

  • Why am I being asked to take part in this study?

  • Who is paying for the study?

  • Who is doing the study and what are their qualifications?

  • Where is the study being done?

  • What kinds of tests or procedures will be done as part of this study?

How will the treatment, tests or procedures differ from those I would receive if I did not participate in the study?

  • How long will the study last?

  • How will my safety be monitored?

  • How will my privacy be protected?

  • What are the risks, side effects and/or discomforts of this study?

  • What are the possible benefits?

  • What are the results of any previous studies performed?

  • What are the alternative treatments and how effective are they?

  • Will I have to pay for any part of the study?

  • What expenses will my insurance carrier cover?

  • What happens if I am harmed by the study?

  • Is there follow up care available after the study?

  • Who do I contact if I have questions related to this study?


Below is a list of the  clinical trials currently being undertaken by the Gastroenterology & Hepatology section at Tulane University.


NCT01672879: Simtuzumab (GS-6624) in the Treatment of Cirrhosis Due to NASH (Gilead Sciences) (2012)

NCT01672866: Simtuzumab (GS-6624) in the Treatment of Liver Fibrosis in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH) (Gilead Sciences) (2012)

NCT01703260: Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis (Takeda Global Research and Development Center, Inc) (2012)

Protocol MK5172-003: 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-Naive Patients with Chronic Genotype 1 Hepatitis C Virus Infection (HCV) (Merck) (Luis Balart, MD, Chaithanya Mallikarjun, MD, Nathan Shores, MD, Lauri Hengl, APRN) (2011)

Protocol WV21913A: A Randomized, Open-label, Multicenter Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (DNV/r) and Copegus®, in Combination with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or Pegasys® in Chronic Hepatitis C Genotype 1 Patients who Failed with a Previous Course of Peginterferon Alfa Plus Ribavirin Combination Therapy (HCV) (Roche) (Luis Balart, MD, Chaithanya Mallikarjun, MD, Nathan Shores, MD, Lauri Hengl, APRN) (2011)

Protocol P05063: 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 (HCV) (Schering Plough/Merck) (Luis Balart, MD, Nathan Shores, MD, Lauri Hengl, APRN) (2010)

VX-950-C211: 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 VX-950- C211 Substudy A Substudy to Investigate Telaprevir-Related Rash in a Selected Number of Subjects Enrolled in Study VX-950-C211 (Tibotec BVBA) (Luis Balart, MD, Lauri Hengl, APRN (2010)

BI 1220.7: A Phase III, Randomised, Double-Blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination with Pegylated Interferon-α and Ribavirin in Patients with Genotype 1 Chronic Hepatitis C Infection who Failed a Prior PegIFN/RBV Treatment (Boehringer Ingelheim Pharmaceuticals, Inc.) (Luis Balart, MD, Chaithanya Mallikarjun, MD, Nathan Shores,MD, Lauri Hengl, APRN) (2011)

BI 1220.47: A Phase III, Randomised, Double-Blind and Placebo-Controlled Study of Once Daily BI 201335 120 mg for 24 weeks and BI 201335 240 mg for 12 weeks in Combination with Pegylated Interferon-α and Ribavirin in Treatment-Naive Patients with Genotype 1 Chronic Hepatitis C Infection (Boehringer Ingelheim Pharmaceuticals, Inc.) (Luis Balart, MD, Chaithanya Mallikarjun, MD, Nathan Shores, MD, Lauri Hengl, APRN) (2011)

BI 1220.48: A Phase III, Open-Label Study of Once Daily BI 201335 240 mg for 24 weeks in Combination with Pegylated Interferon-α (PegIFN) and Ribavirin (RBV) in Patients with Genotype 1 Chronic Hepatitis C Infection who Failed a Prior PegIFN/RBV Treatment (Boehringer Ingelheim Pharmaceuticals, Inc.) (Luis Balart, MD, Chaithanya Mallikarjun, MD, Nathan Shores, MD, Lauri Hengl, APRN) (2011)

BAY 43-9006 / 12414: A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma after Surgical Resection or Local Ablation (Bayer HealthCare Pharmaceuticals) (Luis Balart, MD, Mary Killackey, MD, Marcelo Blaya, MD, Lauri Hengl, APRN (2009)

MCH-02-001: Mochida Pharmaceutical CO., LTD Protocol MCH-02-001: A Phase II double-blind, placebo-controlled study of two doses of EPA-E in patients with NASH (Mochida Pharmaceutical Co. Ltd.) (Luis Balart, MD, Chaithanya Mallikarjun, M.D., Lauri Hengl, APRN) (2010)

CNTO1275CRD3001: A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinamab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (Centocor Ortho Biotech Inc.) (Nabeel Khan, MD, Luis Balart, MD) (2011)

CNTO1275CRD3002: A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinamab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease (Centocor Ortho Biotech Inc.) (Nabeel Khan, MD, Luis Balart, MD) (2011)

CNTO1275CRD3003: A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinamab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease (Centocor Ortho Biotech Inc.) (Nabeel Khan, MD, Luis Balart, MD) (2011)

AI444-038: 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 Myers Squibb) (Luis Balart, MD, Nathan Shores, MD, Chaithanya Mallikarjun, MD, Lauri Hengl, APRN) (2011)

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