Clinical Trials

Clinical trials are biomedical or health-related research studies in human beings that follow a pre-defined protocol. A clinical trial is conducted to answer questions about a certain disease, to test new treatments, or to investigate new ways of using known treatments.

In many cases, the therapies and drugs investigated in clinical trials are not approved by Regulatory Agencies (such as the Food and Drug Administration (FDA) in the United States), and the benefits and risks of taking the treatment are not well known. Clinical trials are used to determine whether treatments are safe and effective for a particular disorder. The clinical testing of experimental treatments or drugs is generally done in three phases with different purposes. The early phases focus on testing safety in a small number of study subjects. Later phases are conducted to further test safety and also test potential benefits. Each successive phase generally involves a larger number of people. 

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate which are based on factors such as age, gender, type of disease, etc. These factors are used to identify appropriate participants for each trial and keep them safe, and also help ensure that questions being studied can be adequately answered. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

Tobira is sponsoring the following Clinical trials…

  • CENTAUR – Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Subjects with Liver Fibrosis
  • ORION – Effects of Cenicriviroc on Insulin Sensitivity in Subjects with Prediabetes or T2DM and Suspected NAFLD
  • PERSEUS – Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects with Primary Sclerosing Cholangitis

Investigators interested in consideration for possible clinical trial participation should contact Eric Lefebvre at info@tobiratx.com