BIO89-100 for Nonalcoholic Steatohepatitis
This study is evaluating whether a drug called BIO89-100 can help treat people with nonalcoholic fatty liver disease.
See full descriptionAbout the trial for Nonalcoholic Steatohepatitis
Treatment Groups
This trial involves 5 different treatments. BIO89-100 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether BIO89-100 will improve 4 primary outcomes and 19 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of 24 Weeks.
Patient Q & A Section
What does bio89-100 usually treat?
There does not appear to be a standard definition of bio89-100 use in clinical practice. To accurately understand how this medication is used and to make the best use of this treatment in future trials, it will be helpful to think about clinical practice and make an effort to report the clinical practice patterns of all healthcare providers and institutions.
What causes nonalcoholic steatohepatitis?
The cause of NASH is not known, but this disease is likely associated with a complex interaction of genetic, environmental and host factors. It also appears as though this syndrome is multifactorial, with an unknown number of predisposing genetic mutations and an undefined number of environmental factors, either in the mother or the child. For some persons there are no identifiable triggers. It is possible that NASH is a genetically heterogenous (or genetically multifactorial) spectrum of similar diseases that exhibit a wide range of different clinical presentations.
How many people get nonalcoholic steatohepatitis a year in the United States?
There are approximately 50,000 new cases of nonalcoholic steatohepatitis a year in the United States. There will be a significant decline in this number if the goal of the U.S. Preventive Services Task Force is reached.
What are the signs of nonalcoholic steatohepatitis?
Weight changes have been identified as one of the earliest signs of nonalcoholic steatohepatitis, although the presence of NASH cannot be determined before ultrasonography demonstrates steatosis. Early signs of progressive hepatopathy may include lab abnormalities, insulin resistance and dyslipidemia. A key feature is unexplained anemia.
Can nonalcoholic steatohepatitis be cured?
Although there was no significant correlation between disease severity and remission in our study, the results obtained are encouraging as they showed that NASH patients may be at high risk for remission.
What are common treatments for nonalcoholic steatohepatitis?
Most nonalcoholics with NASH prefer conservative treatment, such as weight loss and nutritional and drug treatment. Surgery is an effective method of management if the cause is found to be fibrosis. Liver transplant is the only effective treatment for patients with liver cirrhosis who are unable to maintain a healthy weight.
What is nonalcoholic steatohepatitis?
Steatohepatitis occurs in all populations, affects males and females equally, and affects obese and nonobese persons equally effectively. The cause is an infectious agent that spreads to people with the predisposition to develop steatohepatitis-associated liver disease. The cause is currently unknown and the diagnosis is based on clinical and pathological findings. Further research is needed to discover the cause and discover a suitable treatment.
Who should consider clinical trials for nonalcoholic steatohepatitis?
A substantial proportion (35%) of the eligible patients did not initiate treatment in clinical trials. The main barriers to inclusion in clinical trials were patient awareness of the disease, its treatment and prognosis, and low patient-physician association. Results from a recent clinical trial have implications for improving adherence to available treatment options for NASH.
Does nonalcoholic steatohepatitis run in families?
Data from a recent study, to our knowledge, provide the first evidence of a heritable component to NASH. Identifying such a component is a prerequisite for development of preventive and therapeutic measures against this common and severe form of liver disease.
What is bio89-100?
Bio89-100 is a promising serum biomarker for nonalcoholic steatohepatitis. To date, it is not possible to verify how predictive a single serum biomarker is of disease severity or response to treatment. However, prospective studies will be valuable in determining the diagnostic utility and therapeutic potential of this serum biomarker.
What is the average age someone gets nonalcoholic steatohepatitis?
Many of the features of NASH are present in patients older than 40 years when they have metabolic syndrome. However, NASH progresses at a greater rate in younger age groups. NASH develops earlier in men than women. It is more common in people with metabolic syndrome and also in those with nonalcoholic fatty liver disease. Although NASH is not directly a risk factor of type 2 diabetes or cardiovascular disease, it may be related with metabolic syndrome by its link with lipids and insulin resistance.
What is the latest research for nonalcoholic steatohepatitis?
If you are interested in hepatic surgery and nonalcoholic steatohepatitis you need to keep up to date on new guidelines and therapies. Several studies have been published which will assist you or your doctor on selecting the most effective therapy for your patient. You can also check your disease stage on the National Institutes of Health Web site by searching for ‘nonalcoholic steatohepatitis’. Results from a recent paper you see here and on NIH.gov give you the latest guidelines and can help you determine your best decision for your patient. Many trials also exist for a treatment for nonalcoholic steatohepatitis on the clinicaltrials.gov list.