Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver
1 other identifier
interventional
20
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 14, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFebruary 3, 2014
January 1, 2014
1.2 years
October 11, 2011
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events on multiple, escalating IV doses of simtuzumab
The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements
Through Week 14
Secondary Outcomes (4)
Assessment of serum concentration of simtuzumab
Through Week 14
Antibody formation to simtuzumab (anti-simtuzumab Abs)
Through Week 14
Measurement of pharmacodynamic (PD) markers after administration of simtuzumab
Through Week 14
Assessing the effects of chronic dosing of simtuzumab on liver structure and fibrotic markers
Up to 24 weeks
Study Arms (2)
Cohort 1
EXPERIMENTALParticipants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions.
Cohort 2
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (1)
Weill Cornell Medical College: NewYork-Presbyterian Hospital
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeffrey Bornstein, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2011
First Posted
October 14, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2013
Study Completion
August 1, 2013
Last Updated
February 3, 2014
Record last verified: 2014-01