GS-6624 in the Treatment of Liver Fibrosis in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH) - Full Text View

Purpose

The purpose of the study is to evaluate whether GS-6624 is effective in treating liver fibrosis in subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Condition	Intervention	Phase
Non-Alcoholic Steatohepatitis (NASH)	Biological: GS-6624 75 mg Biological: GS-6624 125 mg Biological: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety, and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2) in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Prevent the progression of liver fibrosis in subjects with NASH by using GS-6624 [ Time Frame: Baseline to Week 100 ] [ Designated as safety issue: No ]
Subjects will be taught to self-administer the study medication via subcutaneous injection.

Secondary Outcome Measures:

Assess the safety of GS-6624 in subjects with NASH [ Time Frame: Baseline through Week 100 ] [ Designated as safety issue: Yes ]
Subjects will be assessed throughout the trial for safety and tolerability.

Estimated Enrollment:	225
Study Start Date:	November 2012
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Arm A Subjects will receive subcutaneous injections of GS-6624 75mg once weekly for 96 weeks.	Biological: GS-6624 75 mg The GS-6624 is administered by subcutaneous injection weekly
Experimental: Treatment Arm B Subjects will receive subcutaneous injections of GS-6624 125mg once weekly for 96 weeks.	Biological: GS-6624 125 mg The GS-6624 is administered by subcutaneous injection weekly
Placebo Comparator: Treatment Arm C Subjects will receive subcutaneous injections of placebo of GS-6624 once weekly for 96 weeks	Biological: Placebo The placebo to match GS-6624 is administered by subcutaneous injection weekly

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult subjects (aged 18-60) with chronic liver disease due to NASH defined as macrovesicular steatosis involving >5% of hepatocytes on a liver biopsy with associated lobular inflammation
Stage 3-4 fibrosis by Ishak score on a liver biopsy
Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
Must have AST and ALT ≤ 10 x clULN
Must have serum creatinine < 2.0 mg/dL
A negative serum pregnancy test is required for female subjects of childbearing potential
All sexually active female subjects of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual intercourse throughout the study and for 90 days following the last dose of study medication
Lactating females must agree to discontinue nursing before starting study treatment
Male subjects must refrain from sperm donation from Day 0 throughout the study period and for a period of 90 days following the last dose of study drug

Exclusion Criteria:

Pregnant or breast feeding
Cirrhosis of the liver
Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
Weight reduction surgery in the past 5 years
Positive for HCV RNA
Positive for HBsAg
Alcohol consumption greater than 21oz/week for males or 14oz/week for females
Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening.
Clinically significant cardiac disease
History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening
Major surgical procedure within 30 days prior to screening or the presence of an open wound
Known hypersensitivity to the investigation product or any of its formulation excipients
History of bleeding diathesis within 6 months of screening
Unavailable for follow-up assessment or concern for subject's compliance with the protocol procedures;
Participation in an investigational trial of a drug or device within 30 days prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672866

Contacts

Contact: Jeannine Madere

Jeannine.Madere@gilead.com

Show 26 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Jeffrey Bornstein, MD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01672866 History of Changes
Other Study ID Numbers:	GS-US-321-0105
Study First Received:	August 22, 2012
Last Updated:	June 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

NASH
non cirrhotic
Monoclonal antibody
LOXL2

Additional relevant MeSH terms:

Fibrosis
Liver Cirrhosis
Fatty Liver
Pathologic Processes
Liver Diseases

Digestive System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013