Furthering science, research & medical developments.
Florida Medical Clinic is proud to make a difference by conducting innovative clinical trials to further clinical advancement. Numerous clinical research studies are conducted on an ongoing basis to help further science, research and medical development.
New and exceptional medications waiting for FDA approval are tested in our Clinical Research Department. Nationwide patient results are monitored and evaluated by the FDA in an effort to constantly improve medical treatments. The study length varies according to the test criteria.
Your physician can advise you about your eligibility for clinical research. Medical care, medications, and possible compensation are available to qualified patients who volunteer for a clinical trial.
If you would like additional information on any study listed, please contact:
William D. Johnston RN CCRC
Our Current Clinical Trials
A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis
Protocol Name: AURORA
Protocol Number: 3152-301-002
Description: The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Subjects from Part 1 will continue into Part 2 and additional subjects will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.
Eligibility: 18 Years to 75 Years
- Male and female subjects aged between 18-75 years
- Ability to understand and sign a written informed consent form (ICF)
- Histological evidence of NASH based on central reading of the Screening biopsy
- Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides
- Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating hormone (FSH) ≥ 30 mU/mL at Screening.
- Inability to undergo a liver biopsy
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody (HCVAb) positive
- Human immunodeficiency virus (HIV)-1 or HIV-2 infection
- Prior or planned liver transplantation
- Other known causes of chronic liver disease
- History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- Alcohol consumption greater than 21 units/week for males or 14 units/week for females
- AST > 200 IU/L in males and females at Screening
- ALT > 250 IU/L in males and > 200 IU/L in females at Screening
- HbA1c > 10% at Screening
- Serum albumin < 3.5 g/dL
- Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
- Platelet count < 100,000/mm3
- Total bilirubin > 1.5 mg/dL
- International normalized ratio (INR) > 1.3
- Model of end stage liver disease (MELD) score > 12
- Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
- History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
- Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
- Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
- Females who are pregnant or breastfeeding
- Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents
- Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the Screening liver biopsy
Start Date: April 20, 2017
Projected End Date: September 16, 2020
ClinicalTrials.gov Identifier: NCT03028740
Study Web Address for Potential Patients: https://www.aurorafornash.com