NCT04202653

Brief Summary

This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

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

December 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 15, 2019

Last Update Submit

December 17, 2019

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HBsAg quantification at week 24

    HBsAg quantification are measured

    week 24

Secondary Outcomes (5)

  • HBsAg loss rates at week 24

    week 24

  • HBsAg seroconversion rates at week 24

    week 24

  • HBeAg loss rates at week 24

    week 24

  • HBeAg seroconversion rates at week 24

    week 24

  • HBV DNA<20IU/mL rates at week 24

    week 24

Study Arms (6)

Naive:ETV

ACTIVE COMPARATOR

Entecavir 0.5 mg po daily for 24 weeks in naive patients

Drug: ETV

Naive:ETV+TQ-A3334

EXPERIMENTAL

Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients

Drug: ETVDrug: TQ-A3334

Naive:ETV+TQ-A3334+TQ-B2450

EXPERIMENTAL

Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients

Drug: ETVDrug: TQ-A3334Drug: TQ-B2450

Experienced:ETV

ACTIVE COMPARATOR

Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients

Drug: ETV

Experienced:ETV+TQ-A3334

EXPERIMENTAL

Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients

Drug: ETVDrug: TQ-A3334

Experienced:ETV+TQ-A3334+TQ-B2450

EXPERIMENTAL

Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients

Drug: ETVDrug: TQ-A3334Drug: TQ-B2450

Interventions

ETVDRUG

entecavir 0.5 mg qd

Experienced:ETVExperienced:ETV+TQ-A3334Experienced:ETV+TQ-A3334+TQ-B2450Naive:ETVNaive:ETV+TQ-A3334Naive:ETV+TQ-A3334+TQ-B2450
TQ-A3334DRUG

TQ-A3334 po qw

Experienced:ETV+TQ-A3334Experienced:ETV+TQ-A3334+TQ-B2450Naive:ETV+TQ-A3334Naive:ETV+TQ-A3334+TQ-B2450
TQ-B2450DRUG

TQ-B2450 q3w iv

Experienced:ETV+TQ-A3334+TQ-B2450Naive:ETV+TQ-A3334+TQ-B2450

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients from 18 to 65 years of age;
  • Chronic hepatitis B infection
  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
  • Agree to participate in the study and sign the patient informed consent.

You may not qualify if:

  • Patients who had NAs resistance;
  • Other antiviral, anti-neoplastic or immunomodulatory treatment;
  • Women with ongoing pregnancy or breast-feeding;
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
  • ALT \>10 ULN;
  • LSM \>9kPa ;
  • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
  • Signs or symptoms of hepatocellular carcinoma;
  • Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening;
  • Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men;
  • Serum creatinine level \> 1.5 ULN in screening period.
  • Phosphorus \< 0.65 mmol/L;
  • ANA \> 1:100;
  • History of severe psychiatric disease;
  • History of a severe seizure disorder or current anticonvulsant use;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Infectious Diseases

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 17, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

December 19, 2019

Record last verified: 2019-12