CompletedNCT04168333Updated Dec 4, 2019

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients

A Phase 1 interventional study of T101 Group and Placebo Group in Hepatitis B Virus (HBV), sponsored by Tasly Tianjin Biopharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by Tasly Tianjin Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 1 year 9 months after the study started (first participant enrolled Jan 2018, registered Oct 2019).

Phase: Phase 1
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

Hepatitis B virus (HBV) infection is a worldwide health problem. It has been proved that the persistence of HBV is associated with the failure to stimulate an efficient HBV-specific immune response. T101, the Chinese counterpart of TG1050, is a replication-defective adenovirus serotype 5 (Ad5) expressing multiple HBV-specific antigens (core, polymerase and envelope) and is used as therapeutic vaccine for chronic hepatitis B patients. The application of T101 aims at inducing a broad HBV-specific cellular immune response and ultimately eliminating HBV infection.

Read the detailed description

This study is a randomized, double-blind, placebo-controlled, single dose (SD) and multiple dose (MD) administration study.

Primary Objective: Safety and tolerability;

Secondary Objective:

Antiviral activity of T101 (HBsAg levels).
Cellular (HBV-specific) and humoral (AD5 neutralizing antibodies, NAd5) immune responses to T101.

Key Inclusion Criteria:

Chronic hepatitis B patients with positive HBsAg.
Patients must be receiving antiviral treatment with nucleoside analogs and have negative HBV DNA (defined as HBV DNA \<20 IU/mL).

Conditions studied

Hepatitis B Virus (HBV)

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Keywords

Hepatitis B virus (HBV) infection

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 36 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Tasly Tianjin Biopharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

1. Signed, written Independent Ethics Committee (IEC)-approved informed consent.
1. Patients can cooperate to finish the trial in accordance with the requirements of protocol.
3）Patients (including partners) are willing to have no pregnancy program and take effective contraceptive measures voluntarily from the initiation of trial to 6 months after the last administration.
1. 18 through 65 years of age, inclusive.
5）Body weight is no less than 50 kg for male or no less than 45 kg for female and body mass index(BMI) must be within the range of 18-30kg/m2.
6）Compensated liver disease; defined as total bilirubin ≤2 × ULN, PT ≤ 1.2 ×ULN, platelets ≥100,000/mm3(100*109/L), serum albumin ≥35 g/L, and no prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage).
1. Patients must be receiving antiviral treatment with nucleoside analog and have negative HBV DNA(defined HBV DNA \<20 IU/Ml).
1. Chronic hepatitis B patients have positive HBsAg.
1. ALT ≤ 1.5×ULN.
1. Haemoglobin ≥ 10 g/L
1. Creatinine clearance > 50mL/min.
1. Neutrophils ≥1,200/mm3(1.2*109/L).
1. FibroScan score ≤ 17.5 kPa within 6 months prior to screening or during screening, or proven not to have cirrhosis according to liver tissues within 12 months.

Exclusion criteria

Exclusion Criteria:

1. Addicted to smoking (>5 cigarettes per day) for 3 months prior to the initiation of trial.
1. Subjects susceptible to allergies, including a history of allergy to investigational medical product (IMP) or its buffer.
1. History of drug abuse and/or alcohol abuse(≥14 units of alcohol per week; 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine).
1. Patients who have donated or lost an amount of blood> 450ml within 3 months prior to the screening of the trial.
1. Patients who are positive urine test of drug on screening or a history of drug abuse or use of narcotic drugs during the past five years.
1. Patients who have used any drug that can alter the enzyme activity of liver within 28 days prior to screening.
1. Patients who have taken any prescription, nonprescription, vitamin product or herbal medicine within 14 days prior to the screening(except for nucleoside analogues).
1. Patients who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks prior to screening, or have strenuous exercise, or other factors that affect drug absorption, distribution, metabolism and excretion.
1. Patients who are taking inhibitors or inducers of CYP3A4, P-gp or Bcrp such as itraconazole, ketoconazole or dronedarone.
1. Patients who have significant changes in diet or exercise habit.
1. Patients who have participated in any clinical trial or taken any IMP within 3 months prior to the trial.
1. Patients with an clinically significant and abnormal ECG.
1. Female patients who are pregnant, breast-feeding or positive result of pregnancy test.
1. Patients with abnormal laboratory test results that have clinically significant or clinically significant disease(including but not limited to the gastrointestinal tract, kidney, liver, neurological, haematological, endocrine, lung, immune, mental or cardiovascular disease).
1. Patients with α-fetoprotein > 50 ng/Ml.
1. Patients with positive hepatitis C antibody, HIV antibody, or Treponema pallidum antibody on screening.
1. Patients who could not be enrolled in the judgement of the investigators.
1. Patients with acute disease or accompanied medication on screening.
1. Patients who have taken chocolate or any food and drink that are rich in caffeine or xanthine within 48 hours prior to the administration of IMP.
1. Patients who have taken any alcohol product within 24 hours prior to the administration of IMP.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 36 participants (actual)

Study arms

Active comparator
T101 Group
The study will consist of 2 cohorts: Single Dose (SD) Cohort: 9 chronic hepatitis B patients will be enrolled and be divided into 3 groups, with 3 patients in each group. Multiple Dose (MD) Cohort: 18 chronic hepatitis B patients will be enrolled and be divided into 2 groups, with 9 patients in each group.
Biological: T101 Group
Placebo comparator
Placebo Group
The study will consist of 2 cohorts: Single Dose (SD) Cohort: 3 chronic hepatitis B patients will be enrolled in this group. Multiple Dose (MD) Cohort: 6 chronic hepatitis B patients will be enrolled in this group.
Biological: Placebo Group

Interventions

BiologicalT101 Group
Single Dose (SD) Cohort: In each group, 3 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+9VP (Group1)/1.0E+10VP (Group2)/1.0E+11VP (Group 3) on D1. Multiple Dose (MD) Cohort: In each group, 9 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+10VP (Group1)/1.0E+11VP (Group2) on D1, D8, D15.
BiologicalPlacebo Group
Single Dose (SD) Cohort: 3 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1. Multiple Dose (MD) Cohort: 6 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1, D8, D15.

What researchers measure

Primary outcomes

Adverse events
Observe all the adverse events of all patients, record their clinical features, severity, time of occurence, end time, duration, treatment measures, recovery and determine their correlation with T101
Time frame: through study completion, an average of 1 year
Vital signs index
vital signs measure: include body temperature, pulse rate, respiratory rate and blood pressure, to observe whether there are abnormal index, especially whether there are abnormal index caused by acute allergic reaction.
Time frame: Single Dose Group: baseline, Day-1, Day1, Day8, Day15, Day2ine9; Multiple Dose Group: baseline, Day-1, Day7, Day8, Day14, Day15, Day22, Day29, Day43, Day71, Day99.
Routine blood test
Observe the blood routine tests results of all patients, compare the change of each index before and after the treatment, and determine their correlation with T101 if abnormal index occur.
Time frame: Single Dose Group: baseline, Day-1, Day8, Day15, Day29; Multiple Dose Group: baseline, Day-1, Day7, Day14, Day22, Day29, Day43, Day71, Day99, Day 197, Day379.
Blood biochemical test
Observe the blood biochemical tests results of all patients, compare the change of each index before and after the treatment, and determine their correlation with T101 if abnormal index occur.
Time frame: Single Dose Group: baseline, Day-1, Day8, Day15, Day29; Multiple Dose Group: baseline, Day-1, Day7, Day14, Day22, Day29, Day43, Day71, Day99, Day 197, Day379.
Coagulation function test
Observe the coagulation function tests results of all patients, compare the change of each index before and after the treatment, and determine their correlation with T101 if abnormal index occur.
Time frame: Single Dose Group: baseline, Day-1, Day8, Day15, Day29; Multiple Dose Group: baseline, Day-1, Day7, Day14, Day22, Day29, Day43, Day71, Day99, Day 197, Day379.
Routine urinalysis
Observe the routine urinalysis tests results of all patients, compare the change of each index before and after the treatment, and determine their correlation with T101 if abnormal index occur.
Time frame: Single Dose Group: baseline, Day-1, Day8, Day15, Day29; Multiple Dose Group: baseline, Day-1, Day7, Day14, Day22, Day29, Day43, Day71, Day99, Day 197, Day379.

Secondary outcomes

HBsAg quantitative levels
Evaluate the efficacy of T101
Time frame: Single Dose Group: Day1, Day29; Multiple Dose Group: Day1, Day29, Day43, Day71, Day99, Day197, Day379.
HBeAg quantitative levels
Evaluate the efficacy of T101
Time frame: Single Dose Group: Day1, Day29; Multiple Dose Group: Day1, Day29, Day43, Day71, Day99, Day197, Day379.
Ad5 neutralizing antibodies
Use Analysis of luciferase Ad5 neutralizing antibody method to evaluate the changes of NAd5 titers after T101 administration
Time frame: Single Dose Group: Day1, Day15, Day29; Multiple Dose Group: Day1, Day29, Day43, Day71, Day99, Day197, Day379.
Cellular and humoral immune responses
Detect the T-cell responses by interferon-γ（INF-γ） ELISPOT
Time frame: Single Dose Group: Day1, Day15, Day29; Multiple Dose Group: Day1, Day29, Day43, Day71, Day99, Day197, Day379.

Study locations

1 site

The First Hospital of Jilin University
Changchun, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04168333
Lead sponsor: Tasly Tianjin Biopharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Nov 19, 2019
Start date: Jan 8, 2018
Primary completion: Oct 14, 2019
Completion: Oct 14, 2019
Last update: Dec 4, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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