- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157257
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
An Open-Label Phase 2 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 : a Multicenter, Randomized, Positive Controlled Clinical Trialcontrolled Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Anbo Xiang, PhD
- Phone Number: 18815317378
- Email: anbo.xiang@qilu-pharma.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Southern Hospital of Southern Medical University
-
Contact:
- Jinlin Hou, PhD
-
-
Jilin
-
Changchun, Jilin, China, 130000
- Recruiting
- The First Hospital of Jilin University
-
Contact:
- Junqi Niu, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Risks of mental and nervous system diseases during screening;
- Pregnant or lactating female subjects; Female subjects of childbearing age who were not willing to use effective contraception throughout the study period or male subjects whose partners were fertile but were not willing to use effective contraception;
- Volunteers who took an Investigational Product within 3 months or who have been within 5 half-lives of other trial drugs before the randomization;
- Any other condition , which in the opinion of investigator would make a patient unfit for participation in a clinical study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QL-007 +TDF
QL-007 200 mg BID +TDF 300 mg QD
|
TDF tablet 300mg QD
Other Names:
QL-007 tablets 200mg BID
Other Names:
|
Experimental: QL-007 +Entecavir
QL-007 200 mg BID +Entecavir 0.5 mg QD
|
QL-007 tablets 200mg BID
Other Names:
Entecavir tablet 0.5mg QD
Other Names:
|
Active Comparator: TDF monotherapy
TDF tablet 300 mg QD
|
TDF tablet 300mg QD
Other Names:
|
Active Comparator: Entecavir monotherapy
Entecavir tablet 0.5 mg QD
|
Entecavir tablet 0.5mg QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Main index of pharmacodynamics
Time Frame: 24 weeks
|
The change of HBsAg levels at week 24 compared to baseline
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary pharmacodynamic index
Time Frame: 96 weeks
|
The changes of HBsAg and HBeAg level at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 compared to baseline
|
96 weeks
|
The secondary pharmacodynamic index
Time Frame: 96 weeks
|
The percentage of subjects with HBsAg and HBeAg serological clearance and/or seroconversion at 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 weeks
|
96 weeks
|
The secondary pharmacodynamic index
Time Frame: 96 weeks
|
The percentage of subjects with normal ALT level at weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96
|
96 weeks
|
Other evaluation indexes of pharmacodynamics exploration
Time Frame: 96 weeks
|
The changes of HBV RNA and HBcrAg compared with baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96
|
96 weeks
|
To evaluate the safety of QL-007 in combination with TDF or Entecavir: incidence of adverse events
Time Frame: 96 weeks
|
The incidence of adverse events
|
96 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Junqi Niu, PhD, The First Hospital of Jilin University
- Principal Investigator: Jinlin Hou, PhD, Southern Hospital of Southern Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Entecavir
Other Study ID Numbers
- QL-007-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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