Liver Fibrosis Clinical Trial
Official title:
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 simtuzumab (GS-6624) in patients
with fibrosis of the liver.
Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of
10 participants who will receive simtuzumab every other week for a total of 3 infusions.
Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a
total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen
in Cohort 1.
Participants from both cohorts who have completed the main study will be allowed to continue
on simtuzumab treatment for an additional extension period, and will receive up to 13
additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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