Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
NCT ID: NCT01452308
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2011-11-30
2013-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Participants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions.
Simtuzumab
Cohort 2
Participants will receive simtuzumab IV every other week for a total of 3 infusions. The dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1 but will not exceed 20 mg/kg.
Simtuzumab
Interventions
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Simtuzumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Bornstein, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Weill Cornell Medical College: NewYork-Presbyterian Hospital
New York, New York, United States
Countries
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Other Identifiers
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GS-US-321-0101
Identifier Type: -
Identifier Source: org_study_id
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