Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ABI-H2158-201 | Hepatitis B
Previous Study | Return to List | Next Study

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 : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Assembly Biosciences 833-509-4583 clinicaltrials@assemblybio.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Assembly Biosciences
Investigators
Layout table for investigator information
Study Director: Katia Alves, MD Assembly Biosciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: December 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents