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

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ClinicalTrials.gov Identifier: NCT03576066
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABI-H0731 Drug: SOC NUC Drug: Placebo Oral Tablet Phase 2

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABI-H0731 & SOC NUC
Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
Drug: ABI-H0731
Participants will receive 300 mg QD ABI-H0731 tablets orally.

Drug: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
Other Names:
  • ETV
  • TDF
  • TAF

Active Comparator: Placebo & SOC NUC
Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Drug: Placebo Oral Tablet
Participants will receive matching QD placebo tablets orally.

Drug: SOC NUC
Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Other Names:
  • ETV
  • TDF
  • TAF




Primary Outcome Measures :
  1. Change in mean log10 serum viral antigen (HBsAg or HBeAg) from Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as compared to placebo + SOC NUC [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events, premature discontinuations, abnormal safety laboratory results, electrocardiogram (ECG), or vital signs [ Time Frame: Up to Follow-up (maximum up to Week 36) ]
  2. Subjects with abnormal alanine aminotransferase (ALT) at Baseline who have normal ALT at Week 24 on ABI-H0731 + NUC therapy as compared with placebo + NUC therapy [ Time Frame: Baseline to Week 24 ]
  3. Trough levels of ABI-H0731 on ABI-H0731 + SOC NUC therapy [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 28 ]
  4. Trough to peak ratios of ABI-H0731 on ABI-H0731 + SOC NUC therapy [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 28 ]
  5. Trough levels of SOC NUC on ABI-H0731 + SOC NUC therapy as compared with placebo + SOC NUC therapy [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 28 ]
  6. Trough to peak ratios of SOC NUC on ABI-H0731 + SOC NUC therapy as compared with placebo + SOC NUC therapy [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 28 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 <lower limit of normal (LLN)
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576066


Contacts
Contact: Assembly Biosciences 855-971-4467 clinicaltrials@assemblybio.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Southern California Research Center Recruiting
Coronado, California, United States, 92118
Asia Pacific Liver Center Recruiting
Los Angeles, California, United States, 90057
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Research and Education Recruiting
San Diego, California, United States, 92115
Medical Associates Research Group Recruiting
San Diego, California, United States, 92123
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Silicon Valley Research Institute Recruiting
San Jose, California, United States, 95128
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
United States, Florida
University of Miami Hospital and Clinics Recruiting
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Digestive Disease Associates Recruiting
Catonsville, Maryland, United States, 21228
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
United States, New Jersey
Infectious Disease Care Recruiting
Hillsborough, New Jersey, United States, 08844
United States, New York
Sing Chan, MD Recruiting
Flushing, New York, United States, 11355
NYU Langone Health Recruiting
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Xiaoli Ma, MD Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Liver Institute of Virginia-McManus Recruiting
Newport News, Virginia, United States, 23602
Canada
Toronto General Hospital Recruiting
Toronto, Canada
Toronto Liver Center Recruiting
Toronto, Canada
GI Research Institute Recruiting
Vancouver, Canada
LAIR Centre Recruiting
Vancouver, Canada
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand
Waikato Hospital Recruiting
Hamilton, New Zealand
Sponsors and Collaborators
Assembly Biosciences

Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT03576066     History of Changes
Other Study ID Numbers: ABI-H0731-201
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assembly Biosciences:
CHB
HBV
HBeAg-positive
hepatitis B
HBeAg-negative

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections