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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04157699
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: TDF tablet Drug: QL-007 Phase 2

Detailed Description:
The subjects received the drug treatment for a total of 96 weeks, which was divided into two stages: the first stage: 0-24 weeks as the core treatment period and 25-48 weeks as the extended treatment period. The second stage: 49-96 weeks is the extended treatment period,subjects will enter the second stage of treatment according to the dose of the first stage. When the efficacy data of the first phase determine the optimal dose of QL-007, all subjects entering the second phase will receive the optimal dose of QL-007 and continue treatment with tenofovir dipirofurate fumarate (QL-007 XX mg+TDF) for the second phase 49-96 weeks of extended treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b: a Multicenter, Randomized, Positive Controlled Clinical Trial
Actual Study Start Date : July 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: QL-007 100 mg QD + TDF
QL-007 tablet 100 mg QD was combined with TDF tablet 300mg
Drug: TDF tablet
TDF tablet 300mg QD
Other Name: Tenofovir disoproxil fumarate tablet

Drug: QL-007
QL-007 tablet

Experimental: QL-007 200 mg QD + TDF
QL-007 tablets 200 mg QD were combined with TDF tablet 300mg
Drug: TDF tablet
TDF tablet 300mg QD
Other Name: Tenofovir disoproxil fumarate tablet

Drug: QL-007
QL-007 tablet

Experimental: QL-007 400 mg QD+ TDF
QL-007 tablets 400 mg QD were combined with TDF tablet 300mg
Drug: TDF tablet
TDF tablet 300mg QD
Other Name: Tenofovir disoproxil fumarate tablet

Drug: QL-007
QL-007 tablet

Experimental: QL-007 200 mg BID+ TDF
QL007 tablets 200 mg BID were combined with TDF tablet 300mg
Drug: TDF tablet
TDF tablet 300mg QD
Other Name: Tenofovir disoproxil fumarate tablet

Drug: QL-007
QL-007 tablet

Active Comparator: TDF monotherapy
TDF tablet 300mg
Drug: TDF tablet
TDF tablet 300mg QD
Other Name: Tenofovir disoproxil fumarate tablet




Primary Outcome Measures :
  1. To evaluate the efficacy of QL-007 in combination with TDF in patients with HBeAg-positive chronic hepatitis b: HBV DNA level [ Time Frame: 24 weeks ]
    The change of HBV DNA level at week 24 of treatment compared to baseline


Secondary Outcome Measures :
  1. serological indexs [ Time Frame: 96 weeks ]
    The changes of HBsAg and HBeAg level from baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96

  2. serological indexs [ Time Frame: 96 weeks ]
    The percentage of subjects with HBsAg and HBeAg serological clearance and/or seroconversion at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96

  3. Virological indexs [ Time Frame: 96 weeks ]
    The changes of HBV DNA level compared to baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96

  4. Virological indexs [ Time Frame: 96 weeks ]
    The rate of HBV DNA negative subjects (HBV DNA <60 IU/mL) at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96

  5. biochemistry index [ Time Frame: 96 weeks ]
    The changes of ALT at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 compared to baseline

  6. biochemistry 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

  7. Other evaluation indexes of pharmacodynamics exploration [ Time Frame: 96 weeks ]
    The changes of HBV RNA and HBcrAg level compared with baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96

  8. To evaluate the tolerance of QL-007 in combination with TDF: incidence of adverse events [ Time Frame: 96 weeks ]
    The incidence of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18-70 years (inclusive) with chronic HBV infection prior to baseline;
  2. Positive for HBeAg;
  3. 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;
  4. HBV DNA≥20,000 IU/mL;
  5. ALT levels > upper limit of normal value (ULN) and<5 times ULN;
  6. Participants must have understood and signed the ICF.

Exclusion Criteria:

  1. Known co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
  2. History of liver disease other than chronic hepatitis B, which may affect the judgment of the effectiveness or safety of the study drug
  3. History of Gilbert's Disease;
  4. History of decompensated liver disease or any sign of decompensated liver disease in the screening period;
  5. Evidence of moderate or severe fibrosis or cirrhosis;
  6. Evidence of HCC or AFP > 50 ng / ml in the screening period ;
  7. Any Clinical laboratory values meet certain standards in the screening period;
  8. subjects have clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months);
  9. Risks of serious kidney and respiratory diseases;
  10. Impaired gastrointestinal (GI) function or GI disease that may alter absorption of QL-007 as determined by the Investigator;
  11. 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
  12. Intake of any drugs that can reduce enzyme activity;
  13. History of bleeding diathesis;
  14. Risks of mental and nervous system diseases during screening;
  15. 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;
  16. Volunteers who took an Investigational Product within 3 months or who have been within 5 half-lives of other trial drugs before the randomization.
  17. Any other condition , which in the opinion of investigator would make a patient unfit for participation in a clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157699


Contacts
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Contact: Anbo Xiang, PhD 18815317378 anbo.xiang@qilu-pharma.com

Locations
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China, Guangdong
Southern Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jinlin Hou, PhD         
Principal Investigator: Jinlin Hou, PhD         
China, Jilin
The first hospital of Jilin university Recruiting
Changchun, Jilin, China, 130000
Contact: Junqi Niu, PhD         
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Jinlin Hou, PhD Southern Hospital of Southern Medical University
Principal Investigator: Junqi Niu, PhD First Hospital of Jilin University
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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04157699    
Other Study ID Numbers: QL-007-201
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qilu Pharmaceutical Co., Ltd.:
HBeAg-positive chronic hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents