The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
700 mg intravenously for a total of 12 infusions.
NIH Department of Laboratory Medicine
Bethesda, Maryland, United States
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: First dose date up to Week 24 plus 30 days
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
The Ishak fibrosis score measures the degree of liver fibrosis (scarring) and ranges from 0 (best) to 6 (worst). A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time frame: Baseline; Week 24
Change From Baseline in HVPG at Week 24
Time frame: Baseline; Week 24
Change From Baseline in MQC at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Alpha SMA at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24
Time frame: Baseline; Week 24
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