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Chronic Hepatitis bPhase 2NCT04157699

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

A Phase 2 study testing TDF tablet and QL-007 in people with Chronic Hepatitis b, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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+… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis b
What is being tested?
TDF tablet and QL-007
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesChina
Study dates
26 Jul 2019to Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 ;
Show all 19Show fewer
  • 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;
  • 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.

Trial locations and contacts

2 sites in 1 country.

Anbo Xiang, PhD contact

18815317378

anbo.xiang@qilu-pharma.com

China2 sites, 2 recruiting

  • The first hospital of Jilin university

    Changchun, Jilin, 130000

    Junqi Niu, PhD

    Recruiting

  • Southern Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

    Jinlin Hou, PhD

    Jinlin Hou, PhD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
TDF tablet, QL-007
Keywords
HBeAg-positive chronic hepatitis B
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDF tabletDrug

    Also called Tenofovir disoproxil fumarate tablet

    TDF tablet 300mg QD

  • QL-007Drug

    QL-007 tablet

Study groups in NCT04157699
Study groupRoleWhat they receive
QL-007 100 mg QD + TDFExperimentalQL-007 tablet 100 mg QD was combined with TDF tablet 300mg
Receives: Drug: TDF tablet; Drug: QL-007
QL-007 200 mg QD + TDFExperimentalQL-007 tablets 200 mg QD were combined with TDF tablet 300mg
Receives: Drug: TDF tablet; Drug: QL-007
QL-007 400 mg QD+ TDFExperimentalQL-007 tablets 400 mg QD were combined with TDF tablet 300mg
Receives: Drug: TDF tablet; Drug: QL-007
QL-007 200 mg BID+ TDFExperimentalQL007 tablets 200 mg BID were combined with TDF tablet 300mg
Receives: Drug: TDF tablet; Drug: QL-007
TDF monotherapyActive comparatorTDF tablet 300mg
Receives: Drug: TDF tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 weeks

Secondary outcomes (8)

  1. serological indexs

    The changes of HBsAg and HBeAg level from baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96

    Measured: 96 weeks

  2. serological indexs

    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

    Measured: 96 weeks

  3. Virological indexs

    The changes of HBV DNA level compared to baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96

    Measured: 96 weeks

  4. Virological indexs

    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

    Measured: 96 weeks

  5. biochemistry index

    The changes of ALT at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 compared to baseline

    Measured: 96 weeks

  6. biochemistry index

    The percentage of subjects with normal ALT level at weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96

    Measured: 96 weeks

  7. Other evaluation indexes of pharmacodynamics exploration

    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

    Measured: 96 weeks

  8. To evaluate the tolerance of QL-007 in combination with TDF: incidence of adverse events

    The incidence of adverse events

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2019
  2. Study start26 Jul 2019
  3. Primary completionDec 2020 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04157699
Sponsor's protocol ID
QL-007-201
Status last verified
Nov 2019
First submitted
6 Nov 2019
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TDF tablet and QL-007 in people with Chronic Hepatitis b, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anbo Xiang, PhD (18815317378, anbo.xiang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04157699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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