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Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT03109730
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Brief Summary:
The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABI-H0731 Drug: Placebo for ABI-H0731 Drug: Entecavir Drug: Tenofovir Disoproxil Fumarate Drug: Pegasys Phase 1 Phase 2

Detailed Description:
The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : June 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort B1
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Experimental: Cohort B2
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Experimental: Cohort B3
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Experimental: Cohort B4
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Experimental: Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Drug: Entecavir
An antiviral medication used in the treatment of hepatitis B virus infection
Other Name: ETV

Drug: Tenofovir Disoproxil Fumarate
An antiviral medication used in the treatment of hepatitis B virus infection
Other Name: TDF

Experimental: Cohort B6
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Drug: Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Other Name: peginterferon alfa-2a




Primary Outcome Measures :
  1. Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0. [ Time Frame: Up to 57 days ]


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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:

  • Male or female, 18 to 65 years of age
  • Chronic HBV infection
  • Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion Criteria:

  • Seropositive for HIV, HCV, or HDV antibody at Screen
  • Previous treatment with any investigational HBV antiviral treatments within the last 6 months
  • Other known cause of liver disease, including NASH
  • Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention

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): NCT03109730


Locations
Australia, Victoria
Monash University
Clayton, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Korea, Republic of
Hallym University
Chuncheon, Korea, Republic of
CHA Bundang Medical Center
Gyeonggi-do, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of
Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
United Kingdom
King's College Hospital
London, United Kingdom
Royal Free Hospital NHS Foundation Trust
London, United Kingdom
Royal London Hospital
London, United Kingdom
Sponsors and Collaborators
Assembly Biosciences

Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT03109730     History of Changes
Other Study ID Numbers: ABI-H0731-101B
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Peginterferon alfa-2a
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents