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A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03576066
Recruitment Status : Completed
First Posted : July 3, 2018
Results First Posted : January 28, 2021
Last Update Posted : February 17, 2021
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 (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).

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 Participants with cHBV.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 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
Actual Primary Completion Date : July 5, 2019
Actual Study Completion Date : July 5, 2019


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 ABI-H0731 300 mg tablets orally once daily (QD).

Drug: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Other Names:
  • Entecavir (ETV)
  • Tenofovir disoproxil fumarate (TDF)
  • Tenofovir alafenamide (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: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Other Names:
  • Entecavir (ETV)
  • Tenofovir disoproxil fumarate (TDF)
  • Tenofovir alafenamide (TAF)

Drug: Placebo Oral Tablet
Participants will receive placebo matching ABI-0731 tablets orally QD.




Primary Outcome Measures :
  1. Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC [ Time Frame: Baseline to Week 24 ]
  2. Change in Mean log10 Serum 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 Participants With One or More Adverse Events [ Time Frame: Up to Follow-up (maximum up to Week 36) ]
  2. Number of Participants With Premature Study Discontinuation [ Time Frame: Up to Follow-up (maximum up to Week 36) ]
  3. Number of Participants With One or More Abnormal Safety Laboratory Result [ Time Frame: Up to Week 36 ]
  4. Number of Participants With a Clinically-significant Electrocardiogram Abnormality [ Time Frame: Up to Week 24 ]
  5. Number of Participants With a Clinically-significant Change in Vital Signs [ Time Frame: Baseline and up to Week 24 ]
    Vital signs assessed were body temperature, respiratory rate, and pulse rate

  6. Number of Participants 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 ]
    Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).

  7. Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy [ Time Frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 ]
  8. Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy [ Time Frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 ]
  9. Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy [ Time Frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 ]
  10. Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy [ Time Frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 ]
  11. Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy [ Time Frame: Baseline, Weeks 2, 4, 12, and 24 ]
  12. 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, and 24 ]


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 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 ≤limit of quantitation (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 cHBV

Key Exclusion Criteria:

  • Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (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 participant 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 hepatocellular carcinoma (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×upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) >5×ULN at screening
    • International Normalized Ratio (INR) >1.5×ULN
    • Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (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


Locations
Show Show 21 study locations
Sponsors and Collaborators
Assembly Biosciences
  Study Documents (Full-Text)

Documents provided by Assembly Biosciences:
Study Protocol  [PDF] November 9, 2018
Statistical Analysis Plan  [PDF] August 6, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT03576066    
Other Study ID Numbers: ABI-H0731-201
First Posted: July 3, 2018    Key Record Dates
Results First Posted: January 28, 2021
Last Update Posted: February 17, 2021
Last Verified: January 2021
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:
Chronic hepatitis B
HBV
HBeAg-positive
hepatitis B
HBeAg-negative
vebicorvir
VBR
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
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents