Pilot Study of GS-6624 in the Treatment of Liver Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | November 2011 |
| End Date: | June 2013 |
| Contact: | Jeannine Madere |
| Email: | jeannine.madere@gilead.com |
A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver
This study will evaluate the safety and tolerability of GS-6624 in patients with fibrosis of
the liver.
Inclusion Criteria:
- Males and females 18 - 65 years of age
- Chronic liver disease of any etiology
- Stage 1-3 fibrosis by Metavir score on a liver biopsy.
- Body mass index <36 kg/m2
Exclusion Criteria:
- Any evidence of hepatic decompensation past or present
- Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
- Clinically significant cardiac disease
- History of cancer, other than non-melanomatous skin cancer, within 5 years prior to
Screening
- Systemic fungal, bacterial, viral, or other infection that is not controlled
- Use of systemic immunosuppressants within 28 days of the Pre-treatment Phase
- Use of approved therapy for hepatitis C or hepatitis B virus within 28 days of the
Pre-treatment Phase
- Pregnant or lactating
- History of bleeding diathesis within the last 6 months of study Day 1
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