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Trial record 9 of 150 for:    Cirrhosis | Non-Alcoholic Steatohepatitis

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

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ClinicalTrials.gov Identifier: NCT02510599
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Cempra Inc

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

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: solithromycin Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2015
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : February 28, 2017


Arm Intervention/treatment
Experimental: Solithromycin
Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
Drug: solithromycin
Other Name: CEM-101




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510599


Locations
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United States, Ohio
Case Western University Hospitals
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Cempra Inc
Investigators
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Study Director: Robert Dobbins, MD, PhD Cempra Inc

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Responsible Party: Cempra Inc
ClinicalTrials.gov Identifier: NCT02510599     History of Changes
Other Study ID Numbers: CE01-205
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Cempra Inc:
NASH
Liver disease

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Solithromycin
Anti-Bacterial Agents
Anti-Infective Agents