An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b

NCT04157699 | Unknown Phase 2

• 1 other identifier: QL-007-201
• Study Type: interventional
• Target: 100
• 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. 100 Subjects who meet all the selection criteria will be randomly assigned 1:1:1:1:1 to (A) QL007 100 mg QD+ Tenofovir dipirofurate fumarate （TDF）300 mg QD, (B) QL007 200 mg QD+ TDF 300 mg QD, (C) QL007 400 mg QD+ TDF 300 mg QD, (D) QL007 200 mg BID+ TDF 300 mg QD, (E) TDF 300 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 in combination with TDF in HBeAg positive patients with chronic hepatitis b, and to recommend a reasonable regimen for phase III study.

Conditions

Chronic Hepatitis b

Keywords

HBeAg-positive chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of QL-007 in combination with TDF in patients with HBeAg-positive chronic hepatitis b: HBV DNA level

  The change of HBV DNA level at week 24 of treatment compared to baseline

  24 weeks

Secondary Outcomes (8)

• serological indexs

  96 weeks

• serological indexs

  96 weeks

• Virological indexs

  96 weeks

• Virological indexs

  96 weeks

• biochemistry index

  96 weeks

Study Arms (5)

QL-007 100 mg QD + TDF

EXPERIMENTAL

QL-007 tablet 100 mg QD was combined with TDF tablet 300mg

Drug: TDF tablet; Drug: QL-007

QL-007 200 mg QD + TDF

EXPERIMENTAL

QL-007 tablets 200 mg QD were combined with TDF tablet 300mg

Drug: TDF tablet; Drug: QL-007

QL-007 400 mg QD+ TDF

EXPERIMENTAL

QL-007 tablets 400 mg QD were combined with TDF tablet 300mg

Drug: TDF tablet; Drug: QL-007

QL-007 200 mg BID+ TDF

EXPERIMENTAL

QL007 tablets 200 mg BID were combined with TDF tablet 300mg

Drug: TDF tablet; Drug: QL-007

TDF monotherapy

ACTIVE COMPARATOR

TDF tablet 300mg

Drug: TDF tablet

Interventions

TDF tablet DRUG

TDF tablet 300mg QD

Also known as: Tenofovir disoproxil fumarate tablet

QL-007 100 mg QD + TDF; QL-007 200 mg BID+ TDF; QL-007 200 mg QD + TDF; QL-007 400 mg QD+ TDF; TDF monotherapy

QL-007 DRUG

QL-007 tablet

QL-007 100 mg QD + TDF; QL-007 200 mg BID+ TDF; QL-007 200 mg QD + TDF; QL-007 400 mg QD+ 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;
• Positive for HBeAg;
• Patients who had not previously received anti-HBV treatment (including nucleoside or interferon) or had not received antiviral treatment for HBV (including nucleoside or interferon) within 6 months prior to the first taking the study drug;
• HBV DNA≥20,000 IU/mL;
• ALT levels \> upper limit of normal value (ULN) and\<5 times ULN;
• Participants must have understood and signed the ICF.

You may not qualify if:

• Known 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, which may affect the judgment of the effectiveness or safety of the study drug
• History of Gilbert's Disease;
• History of decompensated liver disease or any sign of decompensated liver disease in the screening period;
• Evidence of moderate or severe fibrosis or cirrhosis;
• Evidence of HCC or AFP \> 50 ng / ml in the screening period ;
• Any Clinical laboratory values meet certain standards in the screening period;
• subjects have clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months);
• 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

Interventions

Tenofovir

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 12, 2019

Record last verified: 2019-11

Locations

CN (2)