TrialSite News is on a mission to procure and provide to our readers the necessary knowledge to making decisions about their clinical trial participation and quality of care. In doing so, we have started a research project covering a multitude of clinical investigation sites involved in new treatments for all kinds of medical conditions. This particular summary covers Cullman Clinical Trials’ participation in a new treatment for Nonalcoholic Steatohepatitis (NASH).
About Cullman Clinical Trials
Cullman Clinical Trials is a private, Cullman-Alabama based provider of clinical trials. On their website, they claim: “It is our aim to improve treatments and to provide advancements in Primary Care and Multi-Specialties that result in a better future for all patients, providers, and sponsors.
At Cullman Clinical Trials, we strive to provide high-quality, evidence-based results; personalized services to meet our client’s needs; and superior customer service. We are a dynamic, innovative organization that seeks to produce life-changing research results.
Utilizing class-leading technology, our mission is to conduct high-quality, safe, and successful clinical trials benefiting patients, providers, and sponsors alike. Our goal is to increase medical progress by connecting the dots between patients, providers, and needed medications.”
Tobira Therapeutics, Inc., founded in 2006, was recently acquired by Allergan and they are listed on ClinicalTrials.gov as the sponsor of the study. Tobira Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases.
Study Title, Dates, and Participation
Officially titled “AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis,” this study began in April 2017 and its estimated primary completion date is in October 2021. Its estimated enrollment is 2,000 participants and there are 572 study locations.
Key Principal Investigator
Because their Principal Investigator is not listed on their site, we recommend getting in touch with their Clinical Research Consultant Nancy Wideman for more information.
FDA Findings & Online Presence
No significant FDA warning letters or inspections were found in our initial research, and we could not find a Facebook or Yelp page. They do, however, have a Google listing but it does not yet have any reviews.
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