CONFIRM Clinical Trial
The CONFIRM clinical trial is a study of terlipressin for the treatment of Hepatorenal Syndrome (HRS) type 1. Even through it’s been used for many years in Europe and other parts of the world, the drug terlipressin is not yet approved by the FDA for use in the United States and Canada as a treatment of HRS type 1 or any other medical condition.
The CONFIRM clinical trial seeks to confirm the efficacy and safety of intravenous terlipressin vs. placebo in treating adults with HRS type 1, a type of kidney failure where there is a rapid increase of creatinine due to liver damage.
Is this Research Study for You?
To qualify, patients need to meet the following minimum criteria:
- Adult with cirrhosis (scarring of the liver), ascites (fluid in the abdomen), and a diagnosis of HRS Type 1
- At least 18 years old
- Have rapidly progressive reduction in renal function
- Have confirmation that albumin was given
- Pass screening tests
How the Study Works
The CONFIRM clinical trial is a placebo-controlled study. This means that patients will either get terlipressin or a placebo (a substance containing no medicine). The chances of you being randomized (like a flip of a coin) to terlipressin is two times to one time placebo. Neither the doctor nor patient knows which treatment is being offered.
Although the chance that the patient may receive the placebo may seem unfair, it is often the best way to prove whether a drug works and is safe. In addition, there is currently no FDA-approved therapy to treat this condition. If you participate in the trial, the study physician will closely monitor your condition.
Treatment may last up to 14 days (plus 2 additional days if applicable). If you show no results by day 4, you would quickly be removed from the study and referred for alternative standard treatments.
Your participation is voluntary and you can leave the study at any time.
Location of the Research Study
Center for Liver, Biliary and Pancreatic Diseases
Broad and Vine Streets
Philadelphia, PA 19102
* Physician's practice/location is independent of Drexel Medicine and Drexel University.
The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.
The images being used are for illustrative purposes only; any person depicted is a model.
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