NCT04189276

Brief Summary

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

November 3, 2019

Last Update Submit

February 5, 2021

Conditions

Hepatitis B Virus (HBV)

Keywords

Hepatitis B Virus (HBV) infection

Outcome Measures

Primary Outcomes (2)

  • All the observed or reported AEs (adverse events)

    observe and record all the AEs of patients during the clinical trial and determine their correlation with the investigational medical product

    through study completion, an average of 60 weeks

  • HBsAg change

    evaluate the HBsAg change from the baseline to evaluate the efficacy of T101

    Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

Secondary Outcomes (4)

  • The percentage of Subjects' HBsAg decrease ≥ 1 log

    Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

  • The percentage of Subjects' HBsAg decrease ≥ 0.5 log

    Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

  • Negative convention rate of HBsAg

    Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

  • Positive convention rate of HBsAb

    Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

Study Arms (4)

Group1

ACTIVE COMPARATOR

T101+ETV(Entecavir) /TDF(Tenofovir)

Biological: ETV/TDF+T101 No.1

Group2

ACTIVE COMPARATOR

T101+ETV/TDF

Biological: ETV/TDF+T101 No.2

Group3

ACTIVE COMPARATOR

ETV or TDF

Biological: ETV or TDF

Group4

ACTIVE COMPARATOR

Peg-IFNα-2b+ETV/TDF

Biological: ETV/TDF+Peg-IFNα-2b

Interventions

ETV/TDF+T101 No.1BIOLOGICAL

Patients will be injected with T101 once on Day1 (Week0), Day8 (Week1), Day15 (Week2), Day106 (Week15), Day113 (Week16), Day120 (Week17), Day211 (Week30), Day218 (Week31), Day225 (Week32), Day316 (Week45), Day323 (Week46), Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.

Group1
ETV/TDF+T101 No.2BIOLOGICAL

Patients will be injected with T101 once on Day1 (Week0), Day106 (Week15), Day211 (Week30), Day316 (Week45); ETV or TDF will be administrated once each day successively until Day420.

Group2
ETV or TDFBIOLOGICAL

Patients will be administrated ETV or TDF once each day successively until Day420.

Group3
ETV/TDF+Peg-IFNα-2bBIOLOGICAL

Patients will be administrated Peg-IFNα-2b successively once a week until Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.

Group4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients between the ages of 18 and 60 years, male or female;
  • \. Body weight is no less than 45kg for female and no less than 50kg for male;
  • \. Meets the diagnosis and treatment standards of chronic hepatitis B in China's 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B;
  • \. Currently, should have taken nucleoside (acid) analogues for 1 year or more;
  • \. HBV DNA\<100 IU/ml; HBsAg is positive and no more than 3000 IU/ml；HBeAg is negative；
  • \. Be able to understand and sign informed consent.

You may not qualify if:

  • Patients with any of the following items will not be enrolled in this study:
  • \. Pregnant or lactating women; male or female who have planned to have children from the start of the study to sixth month after the end of the study.
  • \. Have received interferon treatment within 6 months prior to the screening;
  • \. Have taken strong immunomodulators (such as adrenocortical hormone, thymosin alpha 1, thymosin 5, etc.) within 6 months before the screening, and the course of treatment was more than 2 weeks;
  • \. Have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) within 6 months before screening, and the course of treatment was more than 2 weeks;
  • \. Currently or previously diagnosed or suspected with cirrhosis or liver cancer; or AFP \> 50ng/ml;
  • \. Liver diseases caused by other causes: including alcoholic hepatitis, drug hepatitis, autoimmune liver disease;
  • \. Currently be infected of HAV, HCV, HDV, HEV, HIV and syphilis;
  • \. Have mental diseases, including but not limited to depression, anxiety, mania, schizophrenia;
  • \. Uncontrolled epilepsy;
  • \. Complicated with serious systemic diseases, including but not limited to: autoimmune diseases (such as psoriasis, systemic lupus erythematosus, etc.); not well controlled cardiovascular disease (such as high blood pressure, unstable angina pectoris, heart failure, etc.), endocrine system disease (such as thyroid function hyperfunction or loss, diabetes, etc.), respiratory system diseases (such as pulmonary infection, chronic obstructive pulmonary disease and pulmonary interstitial diseases, etc.), digestive system diseases (e.g., chronic colitis, etc.), kidney disease (such as chronic kidney disease, renal insufficiency, etc.), blood system diseases (such as autoimmune anemia, hemophilia, etc.); currently or previously diagnosed or suspected with malignant tumor;
  • \. Fundus diseases, such as not well controlled retinopathy, etc.;
  • \. Laboratory neutrophil count\<1.5×109/L; platelet count \<90×109/L;
  • \. Prothrombin time was extended by more than 3 seconds compared with the upper limit of normal reference value (ULN);
  • \. ALT\>1.5×ULN; TBIL\>2×ULN; SCR\>1.5×ULN; serum creatine kinase \>3×ULN; ALB\<35g/L;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, 300150, China

Location

MeSH Terms

Conditions

Hepatitis BInfections

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2019

First Posted

December 6, 2019

Study Start

December 10, 2019

Primary Completion

June 30, 2021

Study Completion

December 1, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

CN(3)