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A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection

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ClinicalTrials.gov Identifier: NCT04781647
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Brief Summary:
The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABI-H0731 Drug: ETV Biological: Peg-IFNα Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2a, Multicenter, Open-label Study Evaluating ABI-H0731-Containing Regimens in Patients With Chronic Hepatitis B
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ABI-H0731 + ETV
Participants with cHBV will receive ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks
Drug: ABI-H0731
Participants will receive ABI-H0731 300 mg tablets orally once daily
Other Name: Vebicorvir

Drug: ETV
Participants will receive ETV 0.5 mg tablets orally once daily
Other Name: Entecavir

Experimental: ABI-H0731 + ETV + Peg-IFNα
Participants with cHBV will receive ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks
Drug: ABI-H0731
Participants will receive ABI-H0731 300 mg tablets orally once daily
Other Name: Vebicorvir

Drug: ETV
Participants will receive ETV 0.5 mg tablets orally once daily
Other Name: Entecavir

Biological: Peg-IFNα
Participants will receive Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Other Name: Pegylated-interferon Alpha

Active Comparator: ETV + Peg-IFNα
Participants with cHBV will receive ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks
Drug: ETV
Participants will receive ETV 0.5 mg tablets orally once daily
Other Name: Entecavir

Biological: Peg-IFNα
Participants will receive Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Other Name: Pegylated-interferon Alpha




Primary Outcome Measures :
  1. Number of Participants with an Adverse Event [ Time Frame: Up to 60 weeks ]
  2. Number of Participants with Premature Discontinuation of Treatment [ Time Frame: Up to 60 weeks ]
  3. Number of Participants with a Laboratory Abnormality [ Time Frame: Up to 60 weeks ]

Secondary Outcome Measures :
  1. Mean Change from Baseline in log10 HBV pregenomic RNA (pgRNA) [ Time Frame: Baseline and at pre-specified time points up to 60 weeks ]
  2. Mean Change from Baseline in log10 HBV DNA [ Time Frame: Baseline and at pre-specified time points up to 60 weeks ]
  3. Mean Change from Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg) [ Time Frame: Baseline and at pre-specified time points up to 60 weeks ]
  4. Mean Change from Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg) [ Time Frame: Baseline and at pre-specified time points up to 60 weeks ]
  5. Mean Change from Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg) [ Time Frame: Baseline and at pre-specified time points up to 60 weeks ]
  6. Number of Participants with Normalized Alanine Aminotransferase (ALT) [ Time Frame: Baseline and at pre-specified time points up to 60 weeks ]
  7. Plasma Concentration of ABI-H0731 [ Time Frame: Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24 ]
  8. Incidence of HBV Variants with Reduced Susceptibility to ABI-H0731 [ Time Frame: Pre-specified time points up to 60 weeks ]


Information from the National Library of Medicine

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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 (BMI) 18 to 36 kg/m^2 and a minimum body weight of 45 kg (inclusive)
  • Female subjects must be non-pregnant and have a negative serum pregnancy test
  • Chronic Hepatitis B defined as HBV infection documented for ≥6 months from Screening
  • HBeAg positive with HBV DNA ≥2 × 10^4 IU/mL at Screening
  • Lack of cirrhosis or advanced liver disease
  • A candidate for interferon-based therapy
  • Agreement to comply with protocol-specified contraceptive requirements
  • Agreement to abstain from alcohol abuse and the use of illicit substances from Screening through the duration of the study
  • In good general health, except for cHBV, in the opinion of the Investigator
  • Able to take oral medication and be willing to receive subcutaneous injections of Peg-IFNα.

Exclusion Criteria:

  • Current or prior treatment for cHBV with 1) nucleos(t)ide reverse transcript inhibitor of HBV polymerase (NrtI) class therapy for >4 weeks, 2) interferon-based therapy or liver-protecting and ALT-lowering treatment including traditional Chinese medicine within 6 months of Screening, 3) lamivudine, telbivudine or adefovir (of any duration), or previous treatment with an investigational agent for HBV infection
  • cHBV infection of mixed (>1) genotype
  • Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV) hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV)
  • Females who are lactating, or wish to become pregnant during the course of the study
  • History or evidence of advanced liver disease or hepatic decompensation at any time prior to, or at the time of Screening
  • History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
  • Clinically significant psychiatric disease, including severe depression, history of suicidal ideation or suicide attempt
  • Clinically significant cardiac disease including poorly controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than cHBV; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment; seizure disorders requiring treatment; ongoing infection 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 study participation
  • History of hepatocellular carcinoma (HCC)
  • History of malignancy other than HCC unless the subject's malignancy has been in complete remission off chemotherapy and without additional medical or surgical interventions during the 3 years before Screening
  • History or presence at Screening of electrocardiogram (ECG) abnormalities deemed clinically significant, in the opinion of the Investigator
  • History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drug
  • History of any significant food or drug-related allergic reactions such as, anaphylaxis or Stevens-Johnson syndrome
  • Exclusionary laboratory results at Screening:

    • Hemoglobin <12g/dL for males or <11g/dL for females
    • Platelet count <100,000/mm^3
    • White blood cell count <2,500/mm^3
    • Absolute neutrophil count <1,500/mm^3
    • Albumin <lower limit of normal
    • History of thyroid disease poorly controlled on prescribed medications, with thyroid-stimulating hormone (TSH), free triiodothyronine or free thyroxine (T4) outside the normal limits
    • Total bilirubin >1.2 × upper limit of normal (ULN)
    • Direct bilirubin >1.2 × ULN
    • ALT ≤2 x ULN or ≥10 × ULN
    • Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100 ng/mL, the participant is eligible if a hepatic imaging trial prior to initiation of study drug reveals no lesions indicative of possible HCC.
    • International Normalized Ratio >1.5 × ULN unless on a stable anticoagulant regimen
    • Glomerular filtration rate <60 mL/min/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration equation
    • Serum creatinine >1.5 x ULN
    • Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator.
  • Subjects receiving prohibited concomitant medications, grapefruit juice, or herbal or over-the-counter medications within 7 days or 5 half-lives prior to study start
  • Participation in another clinical study of a drug or device whereby the last investigational drug/device administration is within 60 days or 5 half-lives prior to study start
  • Subjects who have received, in the previous 4 weeks, a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or high-dose steroids, or other immunosuppressants).

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): NCT04781647


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

Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Beijing YouAn Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100069
China, Guangdong
Nanfang Hospital, First Military Medical University Recruiting
Guangzhou, Guangdong, China, 510000
China, Hubei
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430030
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
China, Jilin
Jilin University First Hospital Not yet recruiting
Chang chun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200025
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Sponsors and Collaborators
Assembly Biosciences
Investigators
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Study Director: Marisol Temech, MD Assembly Biosciences
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Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT04781647    
Other Study ID Numbers: ABI-H0731-203
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: March 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Assembly Biosciences:
cHBV
HBV
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
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Entecavir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs