Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
NCT ID: NCT02510599
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2015-12-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Solithromycin
Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
solithromycin
Interventions
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solithromycin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NAS\> or = 5
* Able to swallow capsules intact
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Melinta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Dobbins, MD, PhD
Role: STUDY_DIRECTOR
Melinta Therapeutics, Inc.
Locations
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Case Western University Hospitals
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CE01-205
Identifier Type: -
Identifier Source: org_study_id
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