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A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

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: NCT02908191
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Study Description
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Brief Summary:
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

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 Drug: Nucleos(t)ide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : June 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABI-H0731 or Matching Placebo
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
 Drug: ABI-H0731
Drug: Placebo for ABI-H0731
Other Name: Sugar pill manufactured to mimic the ABI-H0731 tablet
Experimental: ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
 Drug: ABI-H0731
Drug: Placebo for ABI-H0731
Other Name: Sugar pill manufactured to mimic the ABI-H0731 tablet

Drug: Entecavir
Used to treat adults with chronic hepatitis B virus

Drug: Tenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus
Experimental: ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
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
Drug: Placebo for ABI-H0731
Other Name: 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

Drug: Nucleos(t)ide
Used to treat adults with chronic hepatitis B virus


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy volunteers:

  1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
  2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

CHB patients:

  1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg
  2. Must have chronic hepatitis B with no history of clinical decompensation
  3. Seropositive for HIV, HCV, or HDV antibody at Screen
  4. Previous treatment with any HBV antiviral treatments within the last 3 months
  5. Other known cause of liver disease, including NASH
Contacts and Locations
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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): NCT02908191


Locations
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New Zealand
Auckland, New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
Assembly Biosciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT02908191    
Other Study ID Numbers: ABI-H0731-101
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Peginterferon alfa-2a
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