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OpenTrials
Completed

NCT Number: NCT02510599

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

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

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Key information

Conditions

Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Case Western University Hospitals

Cleveland, Ohio, 44106, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solithromycin

Drug

Other names: CEM-101

Primary outcomes

  1. To evaluate effects on hepatic histology in patients with NASH

    Time frame: 13 weeks

    Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)

Secondary outcomes

  1. Changes in Steatosis on liver biopsy

    Time frame: 13 weeks

    Graded from 0 to 3

  2. Changes in hepatocellular ballooning score on liver biopsy

    Time frame: 13 weeks

    Graded from 0 to 2

  3. Changes in inflammation on liver biopsy

    Time frame: 13 weeks

    Graded from 0 to 3

Sponsors and collaborators

Lead sponsor

Melinta Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2015
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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