Status:
COMPLETED
Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
Lead Sponsor:
Gilead Sciences
Conditions:
Liver Fibrosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver. Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01452308
Start Date
November 1 2011
End Date
August 1 2013
Last Update
February 3 2014
Active Locations (1)
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1
Weill Cornell Medical College: NewYork-Presbyterian Hospital
New York, New York, United States, 10065