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A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398134
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Brief Summary:
This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABI-H2158 Drug: Placebo Drug: Entecavir (ETV) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : January 19, 2023
Estimated Study Completion Date : January 19, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABI-H2158 plus ETV
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Drug: ABI-H2158
3 X 100 mg tablets for oral administration

Drug: Entecavir (ETV)
0.5 mg tablet for oral administration

Placebo Comparator: Placebo plus ETV
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Drug: Placebo
Sugar pill manufactured to mimic the ABI-H2158 tablets

Drug: Entecavir (ETV)
0.5 mg tablet for oral administration




Primary Outcome Measures :
  1. Number of Participants with One or More Adverse Events [ Time Frame: Up to 96 weeks ]
  2. Number of Participants with Premature Treatment Discontinuation due to an Adverse Event [ Time Frame: Up to 96 weeks ]
  3. Change from Baseline in Mean log10 HBV DNA [ Time Frame: Baseline and Week 24 ]

Secondary Outcome Measures :
  1. Trough Plasma Concentration of ABI-H2158 [ Time Frame: Predose on Day 1, Week 4, Week 48, and Week 72 ]
  2. Trough-to-Peak Plasma Concentration Ratio of ABI-H2158 [ Time Frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 ]
  3. Trough Plasma Concentration of ETV [ Time Frame: Predose on Day 1, Week 4, Week 48, and Week 72 ]
  4. Trough-to-Peak Plasma Concentration Ratio of ETV [ Time Frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 ]
  5. Change from Baseline in Mean log10 HBV Pre-genomic RNA (pgRNA) [ Time Frame: Baseline and Week 24 ]
  6. Number of Participants with Reduction in HBV DNA Below the Assay Lower Limit of Quantitation [ Time Frame: Up to 96 weeks ]
  7. Number of Participants with Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation [ Time Frame: Up to 96 weeks ]
  8. Change from Baseline in Plasma HBV Surface Antigen (HBsAg) [ Time Frame: Baseline and up to 96 weeks ]
  9. Change from Baseline in Plasma HBV "e" Antigen (HBeAg) [ Time Frame: Baseline and up to 96 weeks ]
  10. Change from Baseline in Plasma HBV Core-related Antigen (HBcrAg) [ Time Frame: Baseline and up to 96 weeks ]
  11. Number of Participants with Normal Serum Alanine Aminotransferase (ALT) [ Time Frame: Baseline and up to Week 24 ]
  12. Number of Participants with HBV Core Protein Gene Sequence Variation Potentially Associated with Treatment Nonresponse [ Time Frame: Up to 96 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg
  • HBeAg ≥500 IU/mL at Screening
  • In good general health except for chronic HBV infection for ≥6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart
  • Lack of cirrhosis or advanced liver disease

Exclusion Criteria:

  • Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an investigational agent for HBV infection
  • History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
  • History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment

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): NCT04398134


Contacts
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Contact: Assembly Biosciences 833-509-4583 clinicaltrials@assemblybio.com

Locations
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United States, California
Coalition of Inclusive Medicine Recruiting
Los Angeles, California, United States, 90020
California Liver Research Institute Recruiting
Pasadena, California, United States, 91105
Research and Education Inc. Recruiting
San Diego, California, United States, 92105
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
United States, Florida
University of Miami/Schiff Center for Liver Diseases Recruiting
Miami, Florida, United States, 33136
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
American Research Corporation at the Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Australia, New South Wales
John Hunter Hospital Recruiting
New Lambton, New South Wales, Australia, 2305
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Canada, British Columbia
(G.I.R.I.) GI Research Institute Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Toronto Liver Centre Recruiting
Toronto, Ontario, Canada, M6H 3M1
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand, 2105
Sponsors and Collaborators
Assembly Biosciences
Investigators
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Study Director: Katia Alves, MD Assembly Biosciences
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Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT04398134    
Other Study ID Numbers: ABI-H2158-201
2019-004902-85 ( EudraCT Number )
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assembly Biosciences:
HBV
hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents