Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/22/2017 |
| Start Date: | December 2015 |
| End Date: | February 28, 2017 |
An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for 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.
and biomarkers in patients with nonalcoholic steatohepatitis.
Patients will be administered solithromycin for 13 weeks with regular safety visits and
liver biopsies at baseline and after treatment.
liver biopsies at baseline and after treatment.
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
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Pierre Gholam, MD
Phone: 216-844-3878
Click here to add this to my saved trials
