Chronic Hepatitis BPhase 1NCT02908191
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
A Phase 1 study testing ABI-H0731, Entecavir and Tenofovir disoproxil fumarate in people with Chronic Hepatitis B, run by Assembly Biosciences at 2 sites in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- 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
- 86 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Nov 2016to 12 Jun 2018
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Healthy volunteers:
- Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
- 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:
- 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
- Must have chronic hepatitis B with no history of clinical decompensation
- Seropositive for HIV, HCV, or HDV antibody at Screen
- Previous treatment with any HBV antiviral treatments within the last 3 months
- Other known cause of liver disease, including NASH
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- 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
Placebo for ABI-H0731Drug
Also called Sugar pill manufactured to mimic the ABI-H0731 tablet
EntecavirDrug
Used to treat adults with chronic hepatitis B virus
Tenofovir disoproxil fumarateDrug
Used to treat adults with chronic hepatitis B virus
PegasysDrug
Also called peginterferon alfa-2a
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Nucleos(t)ideDrug
Used to treat adults with chronic hepatitis B virus
| Study group | Role | What they receive |
|---|---|---|
| ABI-H0731 or Matching Placebo | Experimental | ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731 |
| ABI-H0731 or Placebo and ETV or TDF | Experimental | ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days Receives: Drug: ABI-H0731; Drug: Placebo for ABI-H0731; Drug: Entecavir; Drug: Tenofovir disoproxil fumarate |
| ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys | 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; Drug: Nucleos(t)ide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events 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 posted20 Sep 2016 (estimated)
- Study startNov 2016
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 86 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
- NCT02908191
- Sponsor's protocol ID
- ABI-H0731-101
- Status last verified
- Apr 2019
- First submitted
- 14 Sep 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yuen MF, Agarwal K, Gane EJ, Schwabe C, Ahn SH, Kim DJ, Lim YS, Cheng W, Sievert W, Visvanathan K, Ruby E, Liaw S, Yan R, Huang Q, Colonno R, Lopatin U. Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):152-166. doi: 10.1016/S2468-1253(19)30346-2. Epub 2019 Nov 9.
PubMed 31711752
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02908191
- Acronym / sponsor ID
- ABI-H0731-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABI-H0731 or Matching Placebo | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days |
| ABI-H0731 or Placebo and ETV or TDF | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731, Drug: Entecavir, Drug: Tenofovir disoproxil fumarateABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days |
| ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys | Experimental | Drug: ABI-H0731, Drug: Placebo for ABI-H0731, Drug: Pegasys, Drug: Nucleos(t)ideABI-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
- Accepted
- Age groups
- Adult, Older adult
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-H0731 | Drug | ABI-H0731 or Matching Placebo, ABI-H0731 or Placebo and ETV or TDF, ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys |
| Placebo for ABI-H0731Also: Sugar pill manufactured to mimic the ABI-H0731 tablet | Drug | ABI-H0731 or Matching Placebo, ABI-H0731 or Placebo and ETV or TDF, ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys |
| EntecavirUsed to treat adults with chronic hepatitis B virus | Drug | ABI-H0731 or Placebo and ETV or TDF |
| Tenofovir disoproxil fumarateUsed to treat adults with chronic hepatitis B virus | Drug | ABI-H0731 or Placebo and ETV or TDF |
| PegasysAlso: peginterferon alfa-2aUsed to treat adults with chronic hepatitis B virus who show signs of liver damage | Drug | ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys |
| Nucleos(t)ideUsed to treat adults with chronic hepatitis B virus | Drug | ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys |
Primary outcome
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
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 4 Apr 2019.
- Derived from this study: PubMed 31711752Yuen MF, Agarwal K, Gane EJ, Schwabe C, Ahn SH, Kim DJ, Lim YS, Cheng W, Sievert W, Visvanathan K, Ruby E, Liaw S, Yan R, Huang Q, Colonno R, Lopatin U. Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):152-166. doi: 10.1016/S2468-1253(19)30346-2. Epub 2019 Nov 9.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-H0731, Entecavir and Tenofovir disoproxil fumarate in people with Chronic Hepatitis B, run by Assembly Biosciences at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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 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.
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 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908191, which also lists 1 linked publication.
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 4 Apr 2019.