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A Clinical Study of ASC22 in Subjects With Chronic Hepatitis B Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465890
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
Peking University First Hospital
Beijing Clinical Service Center
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: ASC22 Drug: sodium chloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC22 in Patients With Chronic Hepatitis B
Estimated Study Start Date : July 17, 2020
Estimated Primary Completion Date : January 16, 2022
Estimated Study Completion Date : January 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single dose ASC22 injection 0.3mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once.
Drug: ASC22
200mg/1ml/1bottle

Experimental: Single dose ASC22 injection 1.0mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once.
Drug: ASC22
200mg/1ml/1bottle

Experimental: Single dose ASC22 injection 2.5mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once.
Drug: ASC22
200mg/1ml/1bottle

Experimental: Multiple dose ASC22 injection 1.0mg/kg
Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks
Drug: ASC22
200mg/1ml/1bottle

Experimental: Multiple dose ASC22 injection 2.5mg/kg
Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks
Drug: ASC22
200mg/1ml/1bottle

Placebo Comparator: Placebo sodium chloride injection 1.0mg/kg
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).After 2 weeks ASC22 injection subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks.
Drug: ASC22
200mg/1ml/1bottle

Drug: sodium chloride
90mg/10ml/1 bottle

Placebo Comparator: Placebo sodium chloride injection 2.5mg/kg
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). After 2 weeks ASC22 injection subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks.
Drug: ASC22
200mg/1ml/1bottle

Drug: sodium chloride
90mg/10ml/1 bottle




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Evaluate the decline value of HBsAg level. [ Time Frame: 48 weeks ]
    Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).

  2. Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort. [ Time Frame: 48 weeks ]
    Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).

  3. Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort. [ Time Frame: 48 weeks ]
    Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).

  4. Evaluate the changes of peripheral blood lymphocyte subsets in each cohort. [ Time Frame: 48 weeks ]
    Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-65 years old (including boundary value), gender unlimited;
  2. Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
  3. HBV-DNA turns negative after treatment with nucleoside (acid) drugs;
  4. HBsAg≤ 10000 IU/ml;
  5. HBeAg negative;
  6. 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.

Exclusion Criteria:

  1. 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);
  2. 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);
  3. Liver cancer patients or blood AFP>1×ULN;
  4. Patients who received interferon therapy within 6 months before the first administration;
  5. Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);
  6. The investigator judges that the participants are not suitable for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465890


Contacts
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Contact: Guiqiang Wang, MD 86-13911405123 john131212@sina.com
Contact: Jun Li, MD 86-13520089612 lijun1350089612@sina.com

Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Peking University First Hospital
Beijing Clinical Service Center
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04465890    
Other Study ID Numbers: ASC-ASC22-II-CTP-01
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
Chronic Hepatitis b (CHB)
PD-L1
Fc fusion protein injection
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections