Chronic Hepatitis BPhase 1/2NCT03109730
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
A Phase 1/2 study testing ABI-H0731, Entecavir and Tenofovir Disoproxil Fumarate in people with Chronic Hepatitis B, run by Assembly Biosciences at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABI-H0731, Entecavir and Tenofovir Disoproxil Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 15 Jun 2017to 12 Jun 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Australia4 sites
Monash University
Clayton, Victoria
St. Vincent's Hospital
Fitzroy, Victoria
The Alfred Hospital
Melbourne, Victoria
Linear Clinical Research
Nedlands, Western Australia
South Korea4 sites
Hallym University
Chuncheon
CHA Bundang Medical Center
Gyeonggi-do
Asan Medical Center
Seoul
Severance Hospital, Yonsei University
Seoul
United Kingdom3 sites
King's College Hospital
London
Royal Free Hospital NHS Foundation Trust
London
Royal London Hospital
London
Taiwan2 sites
Keelung Chang Gung Memorial Hospital
Keelung
National Taiwan University Hospital
Taipei
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-H0731, Placebo for ABI-H0731, Entecavir, Tenofovir Disoproxil Fumarate, Pegasys
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-H0731Drug
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731Drug
Sugar pill manufactured to mimic the ABI-H0731 tablet
EntecavirDrug
Also called ETV
An antiviral medication used in the treatment of hepatitis B virus infection
Tenofovir Disoproxil FumarateDrug
Also called TDF
An antiviral medication used in the treatment of hepatitis B virus infection
PegasysDrug
Also called peginterferon alfa-2a
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
| Study group | Role | What they receive |
|---|---|---|
| Cohort B1 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731 |
| Cohort B2 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731 |
| Cohort B3 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731 |
| Cohort B4 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731 |
| Cohort B5 | Experimental | ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731; Drug: Entecavir; Drug: Tenofovir Disoproxil Fumarate |
| Cohort B6 | Experimental | ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731; Drug: Pegasys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
Measured: Up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start15 Jun 2017
- Primary completion31 Mar 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109730
- Sponsor's protocol ID
- ABI-H0731-101B
- Status last verified
- Jul 2018
- First submitted
- 6 Apr 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03109730
- Acronym / sponsor ID
- ABI-H0731-101B
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort B1 | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B2 | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B3 | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B4 | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B5 | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731, Drug: Entecavir, Drug: Tenofovir Disoproxil FumarateABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days |
| Cohort B6 | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731, Drug: PegasysABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-H0731A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients | Drug | Cohort B1, Cohort B2, Cohort B3, Cohort B4, Cohort B5, Cohort B6 |
| Placebo for ABI-H0731Sugar pill manufactured to mimic the ABI-H0731 tablet | Drug | Cohort B1, Cohort B2, Cohort B3, Cohort B4, Cohort B5, Cohort B6 |
| EntecavirAlso: ETVAn antiviral medication used in the treatment of hepatitis B virus infection | Drug | Cohort B5 |
| Tenofovir Disoproxil FumarateAlso: TDFAn antiviral medication used in the treatment of hepatitis B virus infection | Drug | Cohort B5 |
| PegasysAlso: peginterferon alfa-2aUsed to treat adults with chronic hepatitis B virus who show signs of liver damage | Drug | Cohort B6 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABI-H0731, Entecavir and Tenofovir Disoproxil Fumarate in people with Chronic Hepatitis B, run by Assembly Biosciences at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, South Korea, United Kingdom, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.