Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510599
• Other study ID #: CE01-205
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2015
• Last updated: March 20, 2017
• Start date: December 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2017
• Source: Cempra Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Description:

Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 28, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologic evidence of NASH based on liver biopsy obtained within 180 days

• NAS> or = 5

• Able to swallow capsules intact

Exclusion Criteria:

• Symptoms of acute liver disease

• Cirrhosis on liver biopsy

• Positive HIV or Hepatitis tests

• Primary Biliary Cirrhosis

• Poorly controlled diabetes with HgA1C >8.5%

• ALT >4-fold upper limit of normal

• QTcF >450 msec

• CrCl <40 mL/min

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• solithromycin

Locations

Country	Name	City	State
United States	Case Western University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cempra Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate effects on hepatic histology in patients with NASH	Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)	13 weeks
Secondary	Changes in Steatosis on liver biopsy	Graded from 0 to 3	13 weeks
Secondary	Changes in hepatocellular ballooning score on liver biopsy	Graded from 0 to 2	13 weeks
Secondary	Changes in inflammation on liver biopsy	Graded from 0 to 3	13 weeks