Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Liver Fibrosis

Treatments: Biological: Simtuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452308

GS-US-321-0101

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Participants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions.

Treatment:

Biological: Simtuzumab

Cohort 2

Experimental group

Description:

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.

Treatment:

Biological: Simtuzumab