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Trial record 3 of 5 for:    ABI-H0731

A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

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: NCT03780543
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Brief Summary:
Open-label, extension study to evaluate the safety and efficacy of combination therapy and it's effect on sustained viral response biomarkers.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABI-H0731 Drug: SOC NUC Phase 2

Detailed Description:
This is an open-label extension protocol which will assess the safety of long-term (up to 18 months in total) combination therapy and its effect on serum biomarkers of sustained virologic response (SVR) such as sustained clearance of serum HBV DNA, quantitative and qualitative reduction in the viral antigens hepatitis B "e" antigen (HBeAg), and hepatitis B surface antigen (HBsAg), as well as exploratory biomarkers such as reduction in circulating HBV RNA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Active Comparator: Early Complete Responders
Subjects who on Day 1 have a 'complete response' will undergo a consolidation treatment period with ABI-H0731 + standard of care nucleos(t)ide (SOC NUC) for 28 weeks, after which time they will discontinue both their ABI-H0731 and SOC NUC. Subjects will continue to be intensively monitored for an additional 24 weeks of post-treatment follow-up to assess for a SVR. After post-treatment follow-up, subjects will continue to be monitored for an additional 24 months during a long-term, off-treatment follow-up period for a total of up to 36 months.
Drug: ABI-H0731
Participants will receive 300 mg QD of ABI-H0731 tablets orally.

Drug: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet QD orally as per approved package insert.
Other Name: Entecavir, tenofovir

Active Comparator: Non Responders
Subjects who at Week 24 have a 'non-response' after receiving combination treatment of ABI-H0731 + SOC NUC will be discontinued from this study at their Week 28 visit and will continue to be followed while continuing on SOC NUC therapy alone for 12 more weeks.
Drug: ABI-H0731
Participants will receive 300 mg QD of ABI-H0731 tablets orally.

Drug: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet QD orally as per approved package insert.
Other Name: Entecavir, tenofovir

Active Comparator: Partial Responders
Subjects who have not met 'complete response' criteria by Week 48 of this study will be considered 'partial responders'. Subjects will continue combination therapy until Week 52 and then will stop therapy with ABI-H0731 at Week 52 and continue to be followed while on their SOC NUC through Week 76.
Drug: ABI-H0731
Participants will receive 300 mg QD of ABI-H0731 tablets orally.

Drug: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet QD orally as per approved package insert.
Other Name: Entecavir, tenofovir

Active Comparator: Late Complete Responders
Subjects who have met 'complete response' criteria by their Week 48 visit will continue combination therapy until Week 52, after which they will stop all HBV treatment (both ABI-H0731 + SOC NUC) and be monitored for an additional 24 weeks post-treatment follow-up to assess SVR at Week 76. After post-treatment follow-up, subjects will continue to be monitored for an additional 18 months during the long-term, off-treatment, follow-up period for up to 36 months.
Drug: ABI-H0731
Participants will receive 300 mg QD of ABI-H0731 tablets orally.

Drug: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet QD orally as per approved package insert.
Other Name: Entecavir, tenofovir




Primary Outcome Measures :
  1. Number of subjects with sustained HBeAg loss (< 0.11 PEI units/mL) in HBeAg positive subjects [ Time Frame: Baseline to Week 24 ]
  2. Number of subjects with sustained viral suppression (below the limits of detection = 20 IU/mL) [ Time Frame: Baseline to Week 24 ]
  3. Number of subjects with loss or stable reduction of HBsAg to ≤ 100 IU/mL [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events, premature discontinuations, abnormal safety laboratory results, abnormal electrocardiogram (ECG), or abnormal vital signs [ Time Frame: Up to maximum Week 52 ]
  2. Number of subjects with abnormal alanine aminotransferase (ALT) at Baseline who have normal ALT at end of treatment (EOT) and end of study (EOS) [ Time Frame: Non Responders: Baseline to Wk 28 (EOT), Wk 40 (EOS); Early Complete Responders: Baseline to Wk 28 (EOT), Month 36 (EOS); Partial Responders: Baseline to Wk 52 (EOT), Wk 76 (EOS); Late Complete Responders: Baseline to Wk 52 (EOT), Month 36 (EOS) ]
  3. Number of subjects with suppression/loss of viral antigen/DNA on combination treatment whose viral antigens rebound off therapy [ Time Frame: Up to 36 months following End of Treatment ]


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 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide informed consent.
  2. Previously enrolled on a study of ABI-H0731 and completed the treatment period, with demonstrated compliance in the opinion of the investigator.
  3. Female subjects must agree to use an effective birth control method for the duration of the study and follow-up, or be surgically sterile for at least 6 months, or at least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels consistent with a postmenopausal status. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of childbearing potential must have a negative serum pregnancy test.
  4. All heterosexually active male subjects must agree to use an effective birth control method for the duration of the study and follow-up. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, hormone-based contraception (only female partner of a male subject), IUD, diaphragm, or cervical cap.
  5. Agreement to adhere to Lifestyle Considerations (including abstaining 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, herbal or other substances, or unnecessary over-the-counter medications throughout study duration.
  6. In good general health except for chronic HBV infection.
  7. Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211 regimen in the opinion of the Investigator.

Exclusion Criteria:

  1. Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of compliance on a previous study of ABI H0731.
  2. Must not have had a treatment-emergent adverse event or laboratory abnormalities deemed clinically significant and possibly or probably related to drug while on a previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for this study.
  3. Current 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 subject unsuitable for the study.
  4. Females who are lactating or pregnant or wish to become pregnant within the duration of the ABI-H0731-211 study.

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): NCT03780543


Locations
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United States, California
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
Southern California Research Center
Coronado, California, United States, 92118
Coalition of Inclusive Medicine
Los Angeles, California, United States, 90057
University of California Los Angeles
Los Angeles, California, United States, 90095
Research and Education
San Diego, California, United States, 92115
Medical Associates Research Group
San Diego, California, United States, 92123
Quest Clinical Research
San Francisco, California, United States, 94115
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Digestive Disease Associates
Catonsville, Maryland, United States, 21228
United States, New Jersey
Infectious Disease Care
Hillsborough, New Jersey, United States, 08844
United States, New York
Sing Chan, MD
Flushing, New York, United States, 11355
NYU Langone Health
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Xiaoli Ma, MD
Philadelphia, Pennsylvania, United States, 19107
Canada, British Columbia
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Toronto Liver Center
Toronto, Ontario, Canada, M6H 3M1
Toronto General Hospital
Toronto, Ontario, Canada
Hong Kong
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
New Zealand
Auckland Clinical Studies
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
United Kingdom
King's College London
London, United Kingdom
Sponsors and Collaborators
Assembly Biosciences

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Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT03780543     History of Changes
Other Study ID Numbers: ABI-H0731-211
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
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:
CHB
HBV
HBeAg positive
HBeAg negative
hepatitis B
hepatitis B virus
SVR

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