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    Summary
    EudraCT Number:2019-004902-85
    Sponsor's Protocol Code Number:ABI-H2158-201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-06-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-004902-85
    A.3Full title of the trial
    A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
    A.4.1Sponsor's protocol code numberABI-H2158-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04398134
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1249-3349
    A.5.4Other Identifiers
    Name:US INDNumber:141964
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAssembly Biosciences
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAssembly Biosciences
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssembly Biosciences
    B.5.2Functional name of contact pointClinical Trials Group
    B.5.3 Address:
    B.5.3.1Street Address331 Oyster Point Boulevard, 4th Floor
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCalifornia 9408
    B.5.3.4CountryUnited States
    B.5.4Telephone number833509-4583
    B.5.6E-mail2158-201-clinicaltrials@assemblybio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameABI-H2158
    D.3.2Product code ABI-H2158
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.1CAS number 2243747-96-6
    D.3.9.2Current sponsor codeABI-H2158
    D.3.9.3Other descriptive nameABI-H2158
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis B Infection
    E.1.1.1Medical condition in easily understood language
    A serious liver infection caused by the hepatitis B virus.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10047450
    E.1.2Term Viral hepatitis B
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the safety and tolerability of ABI-H2158 when administered in combination with Entecavir (ETV) in subjects with Chronic Hepatitis B Infection (CHB)
    - To evaluate the effect of ABI-H2158 in reducing hepatitis B virus (HBV) DNA in subjects with CHB
    E.2.2Secondary objectives of the trial
    - To evaluate the Pharmacokinetics (PK) of ABI-H2158 and ETV in subjects with CHB
    - To evaluate the effect of ABI-H2158 in reducing HBV pgRNA levels in subjects with CHB
    - To evaluate the effect of ABI-H2158 in reducing HBV antigens (ie, HBeAg, HBcrAg, and HBsAg) in subjects with CHB
    - To evaluate the effect of ABI-H2158 on normalization of alanine aminotransferase (ALT) in subjects with abnormal ALT
    - To evaluate the emergence of resistance to ABI-H2158 when administered in combination with ETV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide informed consent
    2. Male or female between the ages 18 and 65 years (inclusive)
    3. Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day 1.
    4. Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart (inclusive of Screening). For subjects without clear documentation of CHB, serum immunoglobulin M (IgM) antibody to the HBV core-related antigen (HBcrAb) must be negative at Screening to exclude acute HBV infection.
    5. Body mass index (BMI) 18 to 36 kg/m2 and a minimum body weight of 45 kg (inclusive)
    6. HBV DNA ≥2 × 105 IU/mL
    7. HBeAg ≥500 IU/mL at Screening
    8. HBsAg >1000 IU/mL at Screening
    9. Lack of cirrhosis or advanced liver disease as documented by the following:
    o Liver biopsy results of METAVIR F0-F2 (absence of bridging fibrosis or cirrhosis) within 1 year of Screening
    OR
    o Fasting FibroScan ≤8 kPa within 3 months of Screening (including Screening visit) or other Sponsor approved hepatic imaging study (hepatic magnetic resonance imaging [MRI], or hepatic ultrasound by a ultrasonographer with expertise in evaluation of liver fibrosis) within 6 months of Screening indicating lack of cirrhosis or advanced liver disease (F0-F2 or equivalent).
    10. Agreement to comply with protocol-specified contraceptive requirements.
    11. Agreement to abstain from alcohol abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)] and the use of illicit substances from screening until end of the study
    12. In good general health, except for CHB
    13. Have the ability to take oral medication and, in the opinion of the Investigator, be willing to adhere to study treatment
    E.4Principal exclusion criteria
    1. Prior treatment for CHB; specifically
    a. lamivudine, telbivudine or adefovir (any duration)
    b. NrtI treatment for > 4 weeks
    c. HBV core inhibitors (any duration)
    d. Previous treatment with an investigational agent for HBV infection
    2. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV)
    3. Females who are lactating, or wish to become pregnant during the course of the study
    4. History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding esophageal varices, hepatic encephalopathy,) at any time prior to, or at the time of Screening.
    5. History of persistent alcohol abuse (alcohol consumption exceeding 2 standard drinks per day on average [1 standard drink = 10 grams of alcohol]) or illicit drug abuse within 3 years before Screening
    6. Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than CHB, 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, 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.
    7. History of hepatocellular carcinoma (HCC)
    8. A 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
    9. Poorly controlled or unstable hypertension; or sustained systolic blood pressure (BP) ≥ 160 mmHg or <90 mmHg, or diastolic BP >95 mmHg or <50 mmHg at Screening
    10. History or presence of electrocardiogram (ECG) abnormalities deemed clinically significant as described in the protocol.
    11. History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drug or PBO formulation
    12. History of any significant food or drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, or urticaria
    13. The following exclusionary laboratory results at Screening and Baseline visit:
    a. Platelet count <100,000/mm3
    b. Albumin < lower limit of normal (LLN)
    c. Total bilirubin >1.2 × upper limit of normal (ULN) unless known Gilbert’s syndrome; subjects with Gilbert’s syndrome are eligible for study participation if the direct bilirubin is within the normal range
    d. Direct bilirubin >1.2 × ULN
    e. ALT >5 × ULN
    f. Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is > ULN but <100 ng/mL, the subject is eligible if a hepatic imaging study prior to initiation of study drug reveals no lesions indicative of possible HCC.
    g. International Normalized Ratio (INR) >1.5 × ULN
    h. Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation [Levey 2009]
    i. Serum hemoglobin A1c (HbA1c) >6.5%
    j. Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator
    14. Subjects receiving prohibited concomitant medications, grapefruit juice, herbal or over-the counter medications (Section 6.4.1) within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the first dose of study drug and for the duration of the study period
    15. Participation in another clinical trial of a drug or device whereby the last investigational drug/ device administration is within 60 days or 5 half-lives prior to the first study drug administration, whichever is longer
    16. Donated or lost >500 mL of blood within 2 months prior to Screening, or plasma donation within 7 days prior to Screening
    E.5 End points
    E.5.1Primary end point(s)
    - The proportion of subjects with AEs, premature treatment discontinuation, and abnormal laboratory results
    - The change in mean log10 HBV DNA from Baseline to Week 24 for ABI-H2158+ETV and PBO+ETV
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events (AEs): At Screening, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24. and then every 4 weeks thereafter through Week 72 and then a 24-week follow-up period
    Laboratory analyses (Chemistry, hematology, Virology/Immunology etc.): At Screening, Day 1, through Week 72 and then a 24-week follow-up period
    HBV DNA: At Screening, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24. and then every 4 weeks thereafter through Week 72 and then a 24-week follow-up period
    E.5.2Secondary end point(s)
    - Analysis of ABI-H2158 and ETV drug concentrations:
    o Trough levels and trough to peak ratios of ABI-H2158 on ABI-H2158+ETV
    o Trough levels and trough to peak ratios of ETV on ABI-H2158+ETV and PBO+ETV
    - The change in mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at each timepoint
    - The change in mean log10 HBV pgRNA from Baseline to Week 24 and at each timepoint for ABI H2158+ETV and PBO+ETV
    - The proportion of subjects with a reduction in HBV DNA below the assay lower limit of quantitation(LLOQ) for ABI-H2158+ETV and PBO+ETV at each timepoint
    - The proportion of subjects with a reduction in HBV pgRNA below the assay LLOQ for ABI-H2158+ETV and PBO+ETV at each timepoint
    - The change in serum viral antigens (ie, HBeAg, HBcrAg, and HBsAg) on ABI-H2158+ETV and PBO+ETV at each timepoint
    - The proportion of subjects with abnormal ALT at Baseline who have normal ALT at Week 24 and at each timepoint on ABI-H2158+ETV and PBO+ETV
    - The incidence of HBV variants with reduced susceptibility to ABI-H2158
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK of ABI-H2158 & ETV: Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 48, 72 only (Pre-dose samples, Post-dose samples between 2 and 4 hours following study drug administration)
    HBV DNA: At Screening, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24. and then every 4 weeks thereafter through Week 72 and then a 24-week follow-up period.
    HBV pgRNA: At Screening, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24. and then every 4 weeks thereafter through Week 72 and then a 24-week follow-up period.
    HBeAg, HBcrAg, and HBsAg: At Screening, Day 1, Weeks 4, 8, 12, 16, 20, 24. and then every 4 weeks thereafter through Week 72 and then a 24-week follow-up period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Hong Kong
    Korea, Republic of
    New Zealand
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completing treatment at Week 72, or following premature treatment discontinuation, all subjects will enter a 24-week follow-up period. During the follow-up period all subjects will remain on ETV and undergo the follow-up assessments as described in the protocol. After completing the 24-week follow-up period, all subjects will resume management by their treating physician in accordance with local standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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