Expired Study
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Cleveland, Ohio 44106


Purpose:

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


Study summary:

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


Criteria:

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


NCT ID:

NCT02510599


Primary Contact:

Study Director
Robert Dobbins, MD, PhD
Cempra Inc


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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