NCT04180150

Brief Summary

This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.

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
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

November 18, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 16, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

November 26, 2019

Last Update Submit

December 12, 2019

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (4)

  • Cmax

    Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).

    Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.

  • Tmax

    To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.

    Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.

  • AUC0-t

    To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.

    Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.

  • Cytokine

    Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.

    Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7.

Secondary Outcomes (2)

  • HBV biomarker

    Day 1 pre-dose, day 84, day 168, day 336 post-dose.

  • Lymphocyte function

    Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.

Study Arms (2)

TQ-A3334 combined with entecavir

EXPERIMENTAL

Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks

Drug: TQ-A3334Drug: Entecavir Tablet

Placebo combined with entecavir

PLACEBO COMPARATOR

Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks

Drug: PlaceboDrug: Entecavir Tablet

Interventions

TQ-A3334DRUG

TQ-A3334 is a kind of TLR7 receptor agonist.

TQ-A3334 combined with entecavir
PlaceboDRUG

Placebo is a treatment which is designed to have no therapeutic value.

Placebo combined with entecavir
Entecavir TabletDRUG

Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.

Placebo combined with entecavirTQ-A3334 combined with entecavir

Eligibility Criteria

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

You may qualify if:

  • \. 18 and 65 years old ; 2. HBsAg positive at least for 6 months ; 3. HBeAg positive chronic hepatitis B, HBV DNA \> 10\^5 copies/ml; 4. Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN; 5. New diagnosed chronic hepatitis B subjects;

You may not qualify if:

  • Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The second affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

The first hospital of Jilin University

Changchun, Jinlin, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

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

Central Study Contacts

Junqi Niu, M.D.

CONTACT

0431-88782168junqiniu@aliyun.com

Hong Ren, M.D.

CONTACT

023-63693213renhong0531@vip.sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 27, 2019

Study Start

November 18, 2019

Primary Completion

September 30, 2020

Study Completion

December 31, 2021

Last Updated

December 16, 2019

Record last verified: 2019-10

Locations

CN(2)