An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy

NCT04157257 | Unknown Phase 2

• 1 other identifier: QL-007-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 60 Subjects who meet all the selection criteria will be randomly assigned to (A) QL007 200mg BID+ Tenofovir dipirofurate fumarate （TDF）300 mg QD, (B) QL007 200 mg BID+ Entecavir 0.5 mg QD, (C)TDF 300 mg QD, (D) Entecavir 0.5 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 tables in combination with TDF or Entecavir in patients with chronic hepatitis b who have received nucleoside (acid) therapy, and to recommend a reasonable regimen for phase III study.

Conditions

Chronic Hepatitis b

Keywords

nucleoside (acid) therapy

Outcome Measures

Primary Outcomes (1)

• Main index of pharmacodynamics

  The change of HBsAg levels at week 24 compared to baseline

  24 weeks

Secondary Outcomes (5)

• The secondary pharmacodynamic index

  96 weeks

• The secondary pharmacodynamic index

  96 weeks

• The secondary pharmacodynamic index

  96 weeks

• Other evaluation indexes of pharmacodynamics exploration

  96 weeks

• To evaluate the safety of QL-007 in combination with TDF or Entecavir: incidence of adverse events

  96 weeks

Study Arms (4)

QL-007 +TDF

EXPERIMENTAL

QL-007 200 mg BID +TDF 300 mg QD

Drug: TDF tablet; Drug: QL-007

QL-007 +Entecavir

EXPERIMENTAL

QL-007 200 mg BID +Entecavir 0.5 mg QD

Drug: Entecavir Tablet; Drug: QL-007

TDF monotherapy

ACTIVE COMPARATOR

TDF tablet 300 mg QD

Drug: TDF tablet

Entecavir monotherapy

ACTIVE COMPARATOR

Entecavir tablet 0.5 mg QD

Drug: Entecavir Tablet

Interventions

TDF tablet DRUG

TDF tablet 300mg QD

Also known as: Tenofovir dipirofurate fumarate tablet

QL-007 +TDF; TDF monotherapy

Entecavir Tablet DRUG

Entecavir tablet 0.5mg QD

Also known as: Entecavir

Entecavir monotherapy; QL-007 +Entecavir

QL-007 DRUG

QL-007 tablets 200mg BID

Also known as: QL-007 tablet

QL-007 +Entecavir; QL-007 +TDF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years (inclusive) with chronic HBV infection prior to baseline;
• Subjects who have received a entecavir or tenofovir ester treatment for more than 1 year before screening ;
• HBsAg \> 250 IU/mL and HBV DNA \< 60 IU/mL at screening period;
• ALT≤ 2×ULN;
• Participants must have understood and signed the ICF.

You may not qualify if:

• Confirmed co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
• History of liver disease other than chronic hepatitis B;
• History of Gilbert's Disease;
• History of decompensated liver disease or any sign of decompensated liver disease at the screening period;
• Evidence of moderate or severe fibrosis or cirrhosis;
• Evidence of HCC or AFP \> 50 ng/ml at the screening period.
• Any Clinical laboratory values meet the certain standards at the screening period;
• Subjects have clinically significant, uncontrolled heart disease and/or recent cardiac event;
• Risks of serious kidney and respiratory diseases;
• Impaired gastrointestinal (GI) function or GI disease that may alter absorption of QL-007 as determined by the Investigator;
• Receiving medications that meet one of the following criteria and that cannot be discontinued ≥1 week prior to the start of treatment QL-007:
• Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes;
• Moderate or strong inhibitors or strong inducers of CYP3A4
• Intake of any drugs that can reduce enzyme activity;
• History of bleeding diathesis;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Southern Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

The first hospital of jilin university

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Heartburn

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Jinlin Hou, PhD

  Southern Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

• Junqi Niu, PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anbo Xiang, PhD

CONTACT

18815317378; anbo.xiang@qilu-pharma.com

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 6, 2019
• First Posted: November 8, 2019
• Study Start: July 26, 2019
• Primary Completion: December 1, 2020
• Study Completion: October 1, 2022
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

CN (2)