Hepatitis B, ChronicPhase 2NCT05107778
Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV
A Phase 2 study testing ASC42 10mg, ASC42 15mg and ih PEG-IFN α-2a in people with Hepatitis B, Chronic, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus. 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?
- ASC42 10mg, ASC42 15mg and ih PEG-IFN α-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
- 43 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 14 Dec 2023
- 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
- 18-65 years old (including 18 and 65 years old);
- Chronic HBV infection confirmed by serological, etiological and clinical diagnosis (HBsAg positive for more than 6 months);
- HBV-DNA negative after nucleoside (acid) treatment;
- Laboratory test values meet the following requirements :
- Liver function : AST, ALT ≤ 3×ULN; serum total bilirubin≤2×ULN; direct bilirubin≤1.5×ULN; serum albumin≥35 g/L (blood collection is not within 2 weeks before transfusion of albumin);
- Hematology: white blood cell count>3.0×109/L, ANC>1.5×109/L; platelet>1×ULN; hemoglobin 120g/L. (No blood transfusion (including transfusion of red blood cells and platelets) and EPO, TPO, leukocyte-stimulating factor were required within 2 weeks before blood collection) ;
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- Renal function: serum creatinine≤1×ULN;
- Thyroid function: TSH and T4 in normal range or thyroid function can be completely controlled ;
- Determination of serum immunoglobulin : IgM≤ULN;
- Coagulation function: International normalized ratio: INR≤1×ULN;
Who cannot join
- Chronic HBV with unexplained portal hypertension;
- Subjects with liver cancer or serum AFP >1×ULN;
- Previously received FXR therapy;
Trial locations and contacts
1 site in 1 country.
China1 site
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: A Phase II Multi-center, Randomized, Single-blind, Placebo-controlled to Evaluate Safety and Efficacy of ASC42 Tablets in Combination With Entecavir and Pegylated Interferon α-2a in Subjects With Chronic Hepatitis B Virus
This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.
- Conditions
- Hepatitis B, Chronic
- Being tested
- ASC42 10mg, ASC42 15mg, ih PEG-IFN α-2a, Entecavir, Placebo
- Keywords
- Hepatitis B, Chronic, ASC42
- 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.
ASC42 10mgDrug
ASC42 10mg orally once daily;
ASC42 15mgDrug
ASC42 15mg orally once daily.
ih PEG-IFN α-2aDrug
ih PEG-IFN α-2a 180μg subcutaneous injection once a week.
EntecavirDrug
Entecavir 0.5 mg orally once daily.
PlaceboDrug
Placebo orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Queue ASC42 10mg | Experimental | ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks. Receives: Drug: ASC42 10mg; Drug: ih PEG-IFN α-2a; Drug: Entecavir |
| Queue ASC42 15mg | Experimental | ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks. Receives: Drug: ASC42 15mg; Drug: ih PEG-IFN α-2a; Drug: Entecavir |
| Queue Placebo | Placebo comparator | Placebo, ih PEG-IFN α-2a and ETV for 12 weeks. Receives: Drug: ih PEG-IFN α-2a; Drug: Entecavir; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum HBsAg change compared with baseline
Measured: Week 12 of intervention\Week 24 of follow-up
Serum HBV pgRNA change compared with baseline
Measured: Week 12 of intervention\Week 24 of follow-up
Secondary outcomes (2)
Serum HBsAg change compared with baseline
Measured: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
Serum HBV pgRNA change compared with baseline
Measured: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 Jan 2022
- Primary completion14 Nov 2023
- Study completion14 Dec 2023
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107778
- Sponsor's protocol ID
- ASC42-201
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-center, Randomized, Single-blind, Placebo-controlled to Evaluate Safety and Efficacy of ASC42 Tablets in Combination With Entecavir and Pegylated Interferon α-2a in Subjects With Chronic Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT05107778
- Acronym / sponsor ID
- ASC42-201
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, Chronic, ASC42
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 4 Nov 2021 (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 phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Queue ASC42 10mg | Experimental | Drug: ASC42 10mg, Drug: ih PEG-IFN α-2a, Drug: EntecavirASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks. |
| Queue ASC42 15mg | Experimental | Drug: ASC42 15mg, Drug: ih PEG-IFN α-2a, Drug: EntecavirASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks. |
| Queue Placebo | Placebo comparator | Drug: ih PEG-IFN α-2a, Drug: Entecavir, Drug: PlaceboPlacebo, ih PEG-IFN α-2a and ETV for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-65 years old (including 18 and 65 years old);
- Chronic HBV infection confirmed by serological, etiological and clinical diagnosis (HBsAg positive for more than 6 months);
- HBV-DNA negative after nucleoside (acid) treatment;
- Laboratory test values meet the following requirements :
Key exclusion criteria (3 listed)
- Chronic HBV with unexplained portal hypertension;
- Subjects with liver cancer or serum AFP >1×ULN;
- Previously received FXR therapy;
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 |
|---|---|---|
| ASC42 10mgASC42 10mg orally once daily; | Drug | Queue ASC42 10mg |
| ASC42 15mgASC42 15mg orally once daily. | Drug | Queue ASC42 15mg |
| ih PEG-IFN α-2aih PEG-IFN α-2a 180μg subcutaneous injection once a week. | Drug | Queue ASC42 10mg, Queue ASC42 15mg, Queue Placebo |
| EntecavirEntecavir 0.5 mg orally once daily. | Drug | Queue ASC42 10mg, Queue ASC42 15mg, Queue Placebo |
| PlaceboPlacebo orally once daily. | Drug | Queue Placebo |
Primary outcome
Serum HBsAg change compared with baseline
Time frame: Week 12 of intervention\Week 24 of follow-up
Serum HBV pgRNA change compared with baseline
Time frame: Week 12 of intervention\Week 24 of follow-up
2 secondary outcomes
Serum HBsAg change compared with baseline
Time frame: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
Serum HBV pgRNA change compared with baseline
Time frame: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
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 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC42 10mg, ASC42 15mg and ih PEG-IFN α-2a in people with Hepatitis B, Chronic, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
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 10 inclusion and 3 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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 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?
Serum HBsAg change compared with baseline (time frame: Week 12 of intervention\Week 24 of follow-up). The study lists 2 primary outcomes in all. 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 4 Apr 2024.