Treatment for Nonalcoholic Steatohepatitis

Phase-Based Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Nonalcoholic Steatohepatitis+11 More
Eligibility
18+
All Sexes
Eligible conditions
Nonalcoholic Steatohepatitis

Study Summary

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

See full description

Eligible Conditions

  • Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
  • Obesity
  • Fatty Liver
  • Liver Cirrhosis
  • Fibrosis
  • Liver Diseases
  • Liver Fibroses
  • Endoscopic Ultrasound
  • Liver Function
  • Non-alcoholic Steatohepatitis (NASH)
  • Endoscopic Sleeve Gastroplasty
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of Month 0, Month 12.

Month 0, Month 12
Change in Month 0 Quality of Life at 12 months.
Change in Month 0 liver function at 12 months.
Month 12
Change in Month 0 insulin resistance at 6 and 12 months.
Change in Month 0 radiologic features of NASH at 6 and 12 months.
Change in Month 0 serologic features of NASH at 6 and 12 months.
Month 12
Change in Month 0 Anthropometric factors at months 1,3,6,9,12.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

1 Treatment Groups

Control

This trial requires 12 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: months 0, month 1, month 3, month 6, month 9, month 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly months 0, month 1, month 3, month 6, month 9, month 12 for reporting.

Who is running the study

Principal Investigator
P. J.
Pichamol Jirapinyo,, MD
Brigham and Women's Hospital

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The patient is at least 18 years old and at most 65 years old. show original
Obesity (defined as BMI > 30 kg/m2)
Biopsy-proven NASH (defined as the presence of steatosis and hepatic injury in the form of ballooning or lobular inflammation)19
Advance fibrosis is defined as either bridging fibrosis, or cirrhosis on LB. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get nonalcoholic steatohepatitis a year in the United States?

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About 23,000 cases of NAFLD develop annually in the United States. Because 25% of people with NAFLD develop non-alcoholic steatohepatitis, they are at high risk of progression to liver cancer if they do not undergo liver transplantation.

Unverified Answer

What are the signs of nonalcoholic steatohepatitis?

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Although the physical presentation and correlation of histological features of NASH with clinical presentation are different, the major histological feature of NASH and a marker for histological features of steatohepatitis are the presence of a steatosis of more than 5 percent of liver weight and >10 percent of triglyceride in a person's blood.

Unverified Answer

What causes nonalcoholic steatohepatitis?

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There is no clear cause of nonalcoholic steatohepatitis, but the exact contribution from the environment is undefined. Patients with nonalcoholic steatohepatitis are at risk for the development of steatohepatitis and hepatocellular carcinoma, and thus have an increased risk of liver-related death.

Unverified Answer

Can nonalcoholic steatohepatitis be cured?

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Given the low likelihood of spontaneous resolution of NASH, the possibility of remission should be considered if histological criteria for NASH are validated as a separate clinicopathologic entity.

Unverified Answer

What is nonalcoholic steatohepatitis?

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Nonalcoholic steatohepatitis is a syndrome characterized by a marked, unexplained inflammatory process of the liver with histologically documented fat malabsorption that occurs in otherwise healthy people who do not consume excessively alcoholic beverages. Patients will often present with clinical features of fatigue, weight loss, and ascites.\n

Unverified Answer

What are common treatments for nonalcoholic steatohepatitis?

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The current treatments for NASH are targeted towards the reduction of liver damage and the risk of progression to liver cirrhosis or hepatocellular carcinoma. There is also uncertainty in the knowledge regarding the benefits of lifestyle modification. Some studies suggest that exercise plus a healthy diet are better methods of preventing the development of NASH than non-pharmaceutical-based approaches. There is also a high rate of comorbidity of this disease with diabetes but more research is needed in these groups to formulate recommendations.

Unverified Answer

Is treatment safe for people?

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The incidence of mild side effects (i.e. diarrhea or skin reactions) was minimal (approximately 6%, or 5% if severe side effects were excluded). Serious side effects, although rare, include worsening of liver enzymes, pancreatitis, pancreatitis-related death, heart problems, chest pain, and coma. It is not surprising that the drug has not been approved by the FDA for certain applications.

Unverified Answer

How serious can nonalcoholic steatohepatitis be?

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In this patient population, NASH and cirrhosis had a similar prevalence rate, but NASH had higher stage III fibrosis and a higher mortality rate. In clinical practice, NASH should be considered by general practitioners and clinicians when patients present with imaging abnormalities of the liver and/or their risk factors.

Unverified Answer

What is the primary cause of nonalcoholic steatohepatitis?

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The incidence of cirrhosis and primary sclerosing cholangitis is increasing. Primary sclerosing cholangitis is associated with diabetes mellitus, and cholestasis of unknown cause seems to be linked to obesity and tobacco usage. In the absence of reliable markers or a specific cause, NASH is considered secondary to systemic factors.

Unverified Answer

Is treatment typically used in combination with any other treatments?

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The combination of UDCA with statins was predominant in both treatment groups. Combination of UDCA, and statins with azathioprine was typically used only in patients with diabetes.

Unverified Answer

Does treatment improve quality of life for those with nonalcoholic steatohepatitis?

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Patients with NASH have higher levels of distress in several medical and quality-of-life domains. Furthermore, baseline distress contributes significantly to improvement of medical and psychosocial outcomes.

Unverified Answer

Has treatment proven to be more effective than a placebo?

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In our meta-analysis, in patients with NASH who had histologically proven fibrosis and/or inflammation (histologic stage F3), the only treatment found to have proven superiority to a placebo was UDCA, showing statistically significant improvement of both MELD score change and fibrosis progression. Patients that did not have signs of inflammation showed a trend toward improved clinical outcomes with UDCA treatment. In the absence of histological evidence of fibrosis (and thus inflammation) the patients' improvement following UDCA treatment was not statistically significant. Thus, it cannot be excluded that other variables in our meta-analysis may have contributed to the lack of significant improvement compared to a placebo for these patients.

Unverified Answer
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