Hepatitis B, ChronicPhase 2NCT03125213
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
A Phase 2 study testing AL-3778 and Peginterferon Alfa-2A in people with Hepatitis B, Chronic, run by Alios Biopharma Inc..
Trial summary
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- AL-3778 and Peginterferon Alfa-2A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2017to 15 Feb 2019
- Phase
- Phase 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
- A female subject must be of non-childbearing potential
- Subjects must have CHB infection, documented by serologic profile consistent for CHB infection at screening:
- serum HBsAg positive (for >6 months)
- serum IgM anti-HBc negative
- Subjects are treatment-naïve and are serum HBeAg positive with:
- serum HBV DNA >=20,000 IU /mL at screening
- HBsAg >250 IU/mL at screening
- ≥2× upper limit of normal (ULN) ALT and ≤5× ULN at screening
Who cannot join
- Positive test for hepatitis A virus immunoglobulin, hepatitis delta antibody (Ab), hepatitis C Ab, human immunodeficiency virus (HIV) Ab and/or evidence of clinically relevant active infection that would interfere with study conduct or its interpretation would also lead to exclusion.
- Positive test for anti-HBs antibodies and anti-HBe antibodies.
- Subjects must have low levels of liver fibrosis that is classified as Metavir F0-F2
- Any history or current evidence of hepatic decompensation
- Subjects must have absence of hepatocellular carcinoma
- Subject with evidence of retinopathy on retinal fundus photographs
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- Exclusions related to interferon use for the purposes of this study
- Subjects with one or more of the following laboratory abnormalities at screening
- serum creatinine elevation >1.0× ULN
- hemoglobin <11 g/dL [males], <10.5 g/dL [females]
- platelet count <125× 109 cells/L
- absolute neutrophil count <1.0× 109 cells/L
- total bilirubin >1.0× ULN; unless known Gilbert's Disease or Dubin-Johnson Syndrome
- Subjects having received an investigational agent or investigational vaccine, or having received a biological product within 12 weeks or 5 half-lives (whichever is longer) prior to baseline (first intake of study drugs).
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of AL-3778 in Combination With Peginterferon Alpha-2a in Treatment Naïve Chronic Hepatitis B Subjects Who Are HBeAg-positive
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve.
The study will consist of a screening phase , a double-blind treatment phase followed by treatment with Peg-IFN alone, and a post-treatment follow-up phase.
Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2 treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:
- Arm A: Peg-IFN plus AL-3778 (N=20)
- Arm B: Peg-IFN plus matching placebo (N=10)
- Conditions
- Hepatitis B, Chronic
- Being tested
- AL-3778, Peginterferon Alfa-2A, Placebo Oral Tablet
- 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.
AL-3778Drug
AL-3778 tablets
Peginterferon Alfa-2ADrug
Peginterferon Alfa-2A for subcutaneous injection
Placebo Oral TabletDrug
Placebo to Match AL-3778 tablet
| Study group | Role | What they receive |
|---|---|---|
| Peg-IFN plus AL-3778 | Active comparator | Not described Receives: Drug: AL-3778; Drug: Peginterferon Alfa-2A |
| Peg-IFN plus matching placebo | Placebo comparator | Not described Receives: Drug: Peginterferon Alfa-2A; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change (measured in log10 IU/mL) in serum HBsAg from baseline at Week 24.
Measured: Day 1 to Week 24
Secondary outcomes (18)
Incidence and severity of AEs
Measured: Screening to Week 72
Incidence and severity of laboratory abnormalities
Measured: Screening to Week 72
Incidence of serious adverse events (SAEs).
Measured: Screening to Week 72
Incidence and severity of AEs leading to study drug discontinuation.
Measured: Screening to Week 72
Changes in serum HBV DNA over time
Measured: Day 1 to Week 72
Proportion of subjects with ALT normalization
Measured: Day 1 to Week 72
Incidence and severity of hepatic flares on treatment
Measured: Day 1 to Week 48
Incidence and severity of hepatic flares off-treatment.
Measured: Week 48 to week 72
Proportions of subjects with HBeAg loss and/or seroconversion.
Measured: Day 1 to Week 72
Proportions of subjects with HBsAg loss and/or seroconversion.
Measured: Day 1 to Week 72
Changes in serum HBsAg and serum HBeAg levels over time.
Measured: Day 1 to Week 72
Proportion of subjects experiencing a viral breakthrough on treatment.
Measured: Day 1 to Week 48
Assess emergence of treatment-associated mutations during study treatment and follow-up with a focus on subjects with treatment failure
Measured: Day 1 to Week 72
Individually derived Bayesian estimates of AL-3778 Steady state plasma concentration (C0h)
Measured: Week 2
Individually derived Bayesian estimates of AL-3778 area under the plasma concentration curve vs time (AUC0-12h)
Measured: Week 2
AL-3778 maximum observed plasma concentration (Cmax)
Measured: Week 2
AL-3778 Steady state plasma concentration (C0h)
Measured: Week 2
AL-3778 area under the plasma concentration curve vs time (AUC0-12h)
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start12 Sep 2017 (estimated)
- Primary completion15 Feb 2019 (estimated)
- Study completion15 Feb 2019 (estimated)
Why it stopped: Sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Kennedy, Study director, Alios Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125213
- Sponsor's protocol ID
- AL-3778-1003
- Status last verified
- Oct 2017
- First submitted
- 12 Apr 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of AL-3778 in Combination With Peginterferon Alpha-2a in Treatment Naïve Chronic Hepatitis B Subjects Who Are HBeAg-positive
- ClinicalTrials.gov ID
- NCT03125213
- Acronym / sponsor ID
- AL-3778-1003
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2017 (estimated)
- Primary completion
- 15 Feb 2019 (estimated)
- Study completion
- 15 Feb 2019 (estimated)
- First posted
- 24 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.
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve.
The study will consist of a screening phase , a double-blind treatment phase followed by treatment with Peg-IFN alone, and a post-treatment follow-up phase.
Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2 treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:
- Arm A: Peg-IFN plus AL-3778 (N=20)
- Arm B: Peg-IFN plus matching placebo (N=10)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peg-IFN plus AL-3778 | Active comparator | Drug: AL-3778, Drug: Peginterferon Alfa-2A |
| Peg-IFN plus matching placebo | Placebo comparator | Drug: Peginterferon Alfa-2A, Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A female subject must be of non-childbearing potential
- Subjects must have CHB infection, documented by serologic profile consistent for CHB infection at screening:
- Subjects are treatment-naïve and are serum HBeAg positive with:
Key exclusion criteria (14 listed)
- Positive test for hepatitis A virus immunoglobulin, hepatitis delta antibody (Ab), hepatitis C Ab, human immunodeficiency virus (HIV) Ab and/or evidence of clinically relevant active infection that would interfere with study conduct or its interpretation would also lead to exclusion.
- Positive test for anti-HBs antibodies and anti-HBe antibodies.
- Subjects must have low levels of liver fibrosis that is classified as Metavir F0-F2
- Any history or current evidence of hepatic decompensation
- Subjects must have absence of hepatocellular carcinoma
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 |
|---|---|---|
| AL-3778AL-3778 tablets | Drug | Peg-IFN plus AL-3778 |
| Peginterferon Alfa-2APeginterferon Alfa-2A for subcutaneous injection | Drug | Peg-IFN plus AL-3778, Peg-IFN plus matching placebo |
| Placebo Oral TabletPlacebo to Match AL-3778 tablet | Drug | Peg-IFN plus matching placebo |
Primary outcome
Mean change (measured in log10 IU/mL) in serum HBsAg from baseline at Week 24.
Time frame: Day 1 to Week 24
18 secondary outcomes
Incidence and severity of AEs
Time frame: Screening to Week 72
Incidence and severity of laboratory abnormalities
Time frame: Screening to Week 72
Incidence of serious adverse events (SAEs).
Time frame: Screening to Week 72
Incidence and severity of AEs leading to study drug discontinuation.
Time frame: Screening to Week 72
Changes in serum HBV DNA over time
Time frame: Day 1 to Week 72
Proportion of subjects with ALT normalization
Time frame: Day 1 to Week 72
Incidence and severity of hepatic flares on treatment
Time frame: Day 1 to Week 48
Incidence and severity of hepatic flares off-treatment.
Time frame: Week 48 to week 72
Proportions of subjects with HBeAg loss and/or seroconversion.
Time frame: Day 1 to Week 72
Proportions of subjects with HBsAg loss and/or seroconversion.
Time frame: Day 1 to Week 72
Changes in serum HBsAg and serum HBeAg levels over time.
Time frame: Day 1 to Week 72
Proportion of subjects experiencing a viral breakthrough on treatment.
Time frame: Day 1 to Week 48
Assess emergence of treatment-associated mutations during study treatment and follow-up with a focus on subjects with treatment failure
Time frame: Day 1 to Week 72
Individually derived Bayesian estimates of AL-3778 Steady state plasma concentration (C0h)
Time frame: Week 2
Individually derived Bayesian estimates of AL-3778 area under the plasma concentration curve vs time (AUC0-12h)
Time frame: Week 2
AL-3778 maximum observed plasma concentration (Cmax)
Time frame: Week 2
AL-3778 Steady state plasma concentration (C0h)
Time frame: Week 2
AL-3778 area under the plasma concentration curve vs time (AUC0-12h)
Time frame: Week 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Individual participant dataSharing planned: No
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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.
William Kennedy study director
Alios Biopharma Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-3778 and Peginterferon Alfa-2A in people with Hepatitis B, Chronic, run by Alios Biopharma Inc..
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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean change (measured in log10 IU/mL) in serum HBsAg from baseline at Week 24. (time frame: Day 1 to Week 24). 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 16 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.