A Study Evaluating ABI-H0731 as Adjunctive Therapy in Patients With Chronic Hepatitis B



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:1/17/2019
Start Date:June 11, 2018
End Date:September 30, 2019

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A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B

The purpose of this study is to determine if ABI-H0731 given in combination with a standard
of care HBV medication is safe and effective in patients with chronic hepatitis B.

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731
as Adjunctive Therapy in Virally-suppressed Patients with Chronic Hepatitis B

Key Inclusion Criteria:

- Male or female between ages 18 and 70 years

- Virologically-suppressed (defined as HBV DNA ≤LOQ) for at least 6 months before
screening on SOC NUC therapy

- HBeAg-positive or HBeAg-negative at screening

- In good general health except for chronic HBV infection

Key Exclusion Criteria:

- Co-infection with HIV, HCV, HEV or HDV

- History or evidence of hepatic decompensation (including gastrointestinal bleeding or
esophageal varices) at any time prior to or at time of screening

- Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or
urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune
disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents,
neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent
treatment, seizure disorders requiring treatment, or other medical conditions
requiring frequent medical management or pharmacologic or surgical treatment that in
the opinion of the Investigator or the Sponsor makes the subject unsuitable for the
study

- Previous treatment with an investigational agent for HBV other than ABI-H0731 in the
last 6 months before screening

- History of HCC

- Females who are lactating or pregnant or wish to become pregnant are excluded from the
study

- Exclusionary laboratory parameters at screening include:

- Platelet count <100,000/mm3

- Albumin
- Direct bilirubin >1.2×ULN

- ALT >5×ULN at screening

- International Normalized Ratio (INR) >1.5×ULN

- Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by CKD-EPI equation
We found this trial at
18
sites
Flushing, New York 11355
487
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from 43215
Flushing, NY
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
1982
mi
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Los Angeles, CA
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
345
mi
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Baltimore, MD
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Beverly Hills, California 90211
1979
mi
from 43215
Beverly Hills, CA
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Catonsville, Maryland 21228
338
mi
from 43215
Catonsville, MD
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Coronado, California 92118
1954
mi
from 43215
Coronado, CA
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105 Raider Boulevard
Hillsborough, New Jersey 08844
443
mi
from 43215
Hillsborough, NJ
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2200 West 3rd Street
Los Angeles, California 90057
1973
mi
from 43215
Los Angeles, CA
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993
mi
from 43215
Miami, FL
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462 1st Avenue
New York, New York 10010
479
mi
from 43215
New York, NY
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
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New York, NY
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Philadelphia, Pennsylvania 19107
416
mi
from 43215
Philadelphia, PA
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
416
mi
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Philadelphia, PA
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San Diego, California 92105
1947
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San Diego, CA
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San Diego, California 92123
1947
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San Diego, CA
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San Francisco, California 94115
2108
mi
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San Francisco, CA
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
2101
mi
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Stanford, CA
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Toronto,
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