Chronic Hepatitis bPhase 2NCT04465890

A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients

A Phase 2 study testing ASC22 and sodium chloride in people with Chronic Hepatitis b, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration. 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?: ASC22 and sodium chloride
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 1 siteChina
Study dates: 17 Jul 2020to 9 Aug 2024
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 boundary value), gender unlimited；
Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
HBV-DNA turns negative after treatment with nucleoside (acid) drugs;
cohort1-5:HBsAg≤ 10000 IU/mL; cohort6: HBsAg≤ 100 IU/mL;
HBeAg negative;
The fertile female subjects or the fertile male subjects agreed to take contraceptive measures from 7 days before the first administration until 24 weeks after the end of the administration cycle of ASC22. The serum pregnancy test of fertile female subjects must be negative within 7 days before the first administration.

Who cannot join

Patients with hepatitis a, hepatitis c (HCV RNA>15IU/L), hepatitis d or HIV infection; Patients with other active infections (e.g., respiratory tract infection, urinary tract infection and herpes simplex, cytomegalovirus, epstein-barr virus);
Fibrosis stage: Cirrhosis, portal hypertension, or advanced fibrosis (defined as Fibroscan≥9.5kPa or ARFI≥1.81m/sec or Fibrosis-4 (FIB-4)≥3.25 or METAVIR F≥3);
Liver cancer patients or blood AFP>1×ULN;
cohort1-5：Patients who received interferon therapy within 6 months before the first administration; cohort6: Patients who received interferon therapy before the first administration;
Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);
The investigator judges that the participants are not suitable for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing

Other trials in China

About this study

Official title: Phase IIa Single Dose and Phase IIb Mutiple Dose Clinical Studies to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneously Injected PD-L1 Antibody ASC22 in Patients With Chronic Hepatitis B

The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.

Read the detailed description

The study consists of two parts: the ASC22 single-dose IIa study and the ASC22 multi-dose IIb study. The IIa study consists of 3 cohorts of 0.3mg/kg, 1.0mg/kg and 2.5mg/kg, and the IIb study consists of 2 cohorts of 1.0mg/kg and 2.5mg/kg. The objective is to evaluate the safety, tolerance and efficacy of ASC22 in patients with chronic hepatitis B (CHB), and to provide a guidance for the determination of dosage regimen.

Conditions: Chronic Hepatitis b
Being tested: ASC22, sodium chloride
Keywords: Chronic Hepatitis b (CHB), PD-L1, Fc fusion protein injection
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.

ASC22Drug
200mg/1ml/1bottle
sodium chlorideDrug
90mg/10ml/1 bottle

Study groups in NCT04465890
Study group	Role	What they receive
cohort1: Single dose ASC22 injection 0.3mg/kg	Experimental	Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once. Receives: Drug: ASC22
cohort2:Single dose ASC22 injection 1.0mg/kg	Experimental	Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once. Receives: Drug: ASC22
cohort3:Single dose ASC22 injection 2.5mg/kg	Experimental	Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once. Receives: Drug: ASC22
cohort4: Multiple dose ASC22 injection 1.0mg/kg	Experimental	Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks Receives: Drug: ASC22
cohort5: Multiple dose ASC22 injection 2.5mg/kg	Experimental	Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks Receives: Drug: ASC22
cohort4: Placebo sodium chloride injection A	Placebo comparator	Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg). Receives: Drug: sodium chloride
cohort5: Placebo sodium chloride injection B	Placebo comparator	Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (2.5mg/kg). Receives: Drug: sodium chloride
cohort6: Multiple dose ASC22 injection 1.0mg/kg	Experimental	Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks Receives: Drug: ASC22
cohort6: Placebo sodium chloride injection A	Placebo comparator	Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg). Receives: Drug: sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the decreased HBsAg levels at 12 or 24 weeks of treatment or at 4, 12, or 24 weeks of follow-up visits compared with baseline.
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Measured: 48 weeks
Evaluate the number of patients with ≥0.5log reduction in HBsAg log10IU/ mL at 12 or 24 weeks of treatment, or at 4, 12, or 24 weeks of follow-up visits compared with baseline.
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Measured: 48 weeks

Secondary outcomes (4)

Evaluate the decline value of HBsAg level.
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Measured: 48 weeks
Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort.
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Measured: 48 weeks
Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort.
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Measured: 48 weeks
Evaluate the changes of peripheral blood lymphocyte subsets in each cohort.
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 20209 Aug 2024

First posted10 Jul 2020
Study start17 Jul 2020
Primary completion9 Aug 2024
Study completion9 Aug 2024

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04465890
Sponsor's protocol ID: ASC-ASC22-II-CTP-01
Status last verified: Sep 2024
First submitted: 22 Jun 2020
Last updated: 2 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis b trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIa Single Dose and Phase IIb Mutiple Dose Clinical Studies to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneously Injected PD-L1 Antibody ASC22 in Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT04465890
Acronym / sponsor ID: ASC-ASC22-II-CTP-01
Conditions: Chronic Hepatitis b
Keywords: Chronic Hepatitis b (CHB), PD-L1, Fc fusion protein injection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Peking University First Hospital, Beijing Clinical Service Center
Study start: 17 Jul 2020 (actual)
Primary completion: 9 Aug 2024 (actual)
Study completion: 9 Aug 2024 (actual)
First posted: 10 Jul 2020 (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 objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 9

Arm	Type	Receives
cohort1: Single dose ASC22 injection 0.3mg/kg	Experimental	Drug: ASC22Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once.
cohort2:Single dose ASC22 injection 1.0mg/kg	Experimental	Drug: ASC22Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once.
cohort3:Single dose ASC22 injection 2.5mg/kg	Experimental	Drug: ASC22Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once.
cohort4: Multiple dose ASC22 injection 1.0mg/kg	Experimental	Drug: ASC22Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks
cohort5: Multiple dose ASC22 injection 2.5mg/kg	Experimental	Drug: ASC22Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks
cohort4: Placebo sodium chloride injection A	Placebo comparator	Drug: sodium chloridePlacebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg).
cohort5: Placebo sodium chloride injection B	Placebo comparator	Drug: sodium chloridePlacebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (2.5mg/kg).
cohort6: Multiple dose ASC22 injection 1.0mg/kg	Experimental	Drug: ASC22Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks
cohort6: Placebo sodium chloride injection A	Placebo comparator	Drug: sodium chloridePlacebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18-65 years old (including boundary value), gender unlimited；
Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
HBV-DNA turns negative after treatment with nucleoside (acid) drugs;
cohort1-5:HBsAg≤ 10000 IU/mL; cohort6: HBsAg≤ 100 IU/mL;
HBeAg negative;

Key exclusion criteria (6 listed)

Patients with hepatitis a, hepatitis c (HCV RNA>15IU/L), hepatitis d or HIV infection; Patients with other active infections (e.g., respiratory tract infection, urinary tract infection and herpes simplex, cytomegalovirus, epstein-barr virus);
Fibrosis stage: Cirrhosis, portal hypertension, or advanced fibrosis (defined as Fibroscan≥9.5kPa or ARFI≥1.81m/sec or Fibrosis-4 (FIB-4)≥3.25 or METAVIR F≥3);
Liver cancer patients or blood AFP>1×ULN;
cohort1-5：Patients who received interferon therapy within 6 months before the first administration; cohort6: Patients who received interferon therapy before the first administration;
Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);

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
ASC22200mg/1ml/1bottle	Drug	cohort1: Single dose ASC22 injection 0.3mg/kg, cohort2:Single dose ASC22 injection 1.0mg/kg, cohort3:Single dose ASC22 injection 2.5mg/kg, cohort4: Multiple dose ASC22 injection 1.0mg/kg, cohort5: Multiple dose ASC22 injection 2.5mg/kg, cohort6: Multiple dose ASC22 injection 1.0mg/kg
sodium chloride90mg/10ml/1 bottle	Drug	cohort4: Placebo sodium chloride injection A, cohort5: Placebo sodium chloride injection B, cohort6: Placebo sodium chloride injection A

Primary outcome

Evaluate the decreased HBsAg levels at 12 or 24 weeks of treatment or at 4, 12, or 24 weeks of follow-up visits compared with baseline.
Time frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Evaluate the number of patients with ≥0.5log reduction in HBsAg log10IU/ mL at 12 or 24 weeks of treatment, or at 4, 12, or 24 weeks of follow-up visits compared with baseline.
Time frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).

4 secondary outcomes

Evaluate the decline value of HBsAg level.
Time frame: 48 weeks
Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort.
Time frame: 48 weeks
Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort.
Time frame: 48 weeks
Evaluate the changes of peripheral blood lymphocyte subsets in each cohort.
Time frame: 48 weeks

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 2 Dec 2024.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Hepatitis b

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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 ASC22 and sodium chloride in people with Chronic Hepatitis b, 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 6 inclusion and 6 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 2 Dec 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?

Evaluate the decreased HBsAg levels at 12 or 24 weeks of treatment or at 4, 12, or 24 weeks of follow-up visits compared with baseline. (time frame: 48 weeks). 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?

On the ClinicalTrials.gov record for NCT04465890.

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 2 Dec 2024.