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Completed

NCT Number: NCT01452308

Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis

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.

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Key information

Conditions

Liver Fibrosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Weill Cornell Medical College: NewYork-Presbyterian Hospital

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simtuzumab

Biological

Other names: GS-6624

Primary outcomes

  1. Incidence of adverse events on multiple, escalating IV doses of simtuzumab

    Time frame: Through Week 14

    The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements

Secondary outcomes

  1. Assessment of serum concentration of simtuzumab

    Time frame: Through Week 14

    Trough concentrations will be summarized by day, treatment and dose.

  2. Antibody formation to simtuzumab (anti-simtuzumab Abs)

    Time frame: Through Week 14

    Immunogenicity endpoints will be geometric mean titer (GMT) and geometric mean fold rate (GMFR) for a select set of antibodies.

  3. Measurement of pharmacodynamic (PD) markers after administration of simtuzumab

    Time frame: Through Week 14

    Pharmacodynamic markers include: Tissue PD markers through mRNA expression, LOXL2, LOX, Other LOXL proteins, αSMA, Collagen 1A1, NFKB1, Caspase 1, SMAD, and NOD; Serum and plasma PD markers include: APRI, LOXL2, Osteopontin, Hyaluronic Acid, CXCL 9, 10 and 11, MMP1, MMP3, MMP9, TIMP1, CD40L, TGF-β1, ET-1, VEGF, GAL3, IL-6 / IL-8 / TNFα / IFNγ, α2-macroglobulin, Apolipoprotein A1.

  4. Assessing the effects of chronic dosing of simtuzumab on liver structure and fibrotic markers

    Time frame: Up to 24 weeks

    Measuring the effect of an additional 24 weeks of simtuzumab dosing on liver histology, LOXL2 and mRNA expression in the liver and serum markers of liver fibrosis

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 14, 2011
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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