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Hepatitis B Virus (HBV)Phase 2NCT04189276

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

A Phase 2 study testing ETV/TDF+T101 No.1, ETV/TDF+T101 No.2 and ETV or TDF in people with Hepatitis B Virus (HBV), run by Tasly Tianjin Biopharmaceutical Co., Ltd. at 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hepatitis B Virus (HBV)
What is being tested?
ETV/TDF+T101 No.1, ETV/TDF+T101 No.2 and ETV or TDF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesChina
Study dates
10 Dec 2019to Dec 2021
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients must meet all the following inclusion criteria to be enrolled in this study:
  • 1. Patients between the ages of 18 and 60 years, male or female;
  • 2. Body weight is no less than 45kg for female and no less than 50kg for male;
  • 3. Meets the diagnosis and treatment standards of chronic hepatitis B in China's 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B;
  • 4. Currently, should have taken nucleoside (acid) analogues for 1 year or more;
  • 5. HBV DNA<100 IU/ml; HBsAg is positive and no more than 3000 IU/ml；HBeAg is negative；
  • 6. Be able to understand and sign informed consent.

Who cannot join

  • Patients with any of the following items will not be enrolled in this study:
  • 1. Pregnant or lactating women; male or female who have planned to have children from the start of the study to sixth month after the end of the study.
  • 2. Have received interferon treatment within 6 months prior to the screening;
  • 3. Have taken strong immunomodulators (such as adrenocortical hormone, thymosin alpha 1, thymosin 5, etc.) within 6 months before the screening, and the course of treatment was more than 2 weeks;
  • 4. Have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) within 6 months before screening, and the course of treatment was more than 2 weeks;
  • 5. Currently or previously diagnosed or suspected with cirrhosis or liver cancer; or AFP > 50ng/ml;
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  • 6. Liver diseases caused by other causes: including alcoholic hepatitis, drug hepatitis, autoimmune liver disease;
  • 7. Currently be infected of HAV, HCV, HDV, HEV, HIV and syphilis;
  • 8. Have mental diseases, including but not limited to depression, anxiety, mania, schizophrenia;
  • 9. Uncontrolled epilepsy;
  • 10. Complicated with serious systemic diseases, including but not limited to: autoimmune diseases (such as psoriasis, systemic lupus erythematosus, etc.); not well controlled cardiovascular disease (such as high blood pressure, unstable angina pectoris, heart failure, etc.), endocrine system disease (such as thyroid function hyperfunction or loss, diabetes, etc.), respiratory system diseases (such as pulmonary infection, chronic obstructive pulmonary disease and pulmonary interstitial diseases, etc.), digestive system diseases (e.g., chronic colitis, etc.), kidney disease (such as chronic kidney disease, renal insufficiency, etc.), blood system diseases (such as autoimmune anemia, hemophilia, etc.); currently or previously diagnosed or suspected with malignant tumor;
  • 11. Fundus diseases, such as not well controlled retinopathy, etc.;
  • 12. Laboratory neutrophil count<1.5×109/L; platelet count <90×109/L;
  • 13. Prothrombin time was extended by more than 3 seconds compared with the upper limit of normal reference value (ULN);
  • 14. ALT>1.5×ULN; TBIL>2×ULN; SCR>1.5×ULN; serum creatine kinase >3×ULN; ALB<35g/L;
  • 15. ANA>1:1000, anti-smooth muscle antibody>1:1000, thyrotropic hormone receptor antibody >2×ULN;
  • 16. Allergic constitution or allergic to experimental drugs and excipients;
  • 17. Plan to receive or have already had an organ transplant;
  • 18. Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial;
  • 19. Other cases that could not be enrolled in the judgement of the investigators.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Youan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100069

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality, 300150

Other trials in China

About this study

Official title: A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.

Being tested
ETV/TDF+T101 No.1, ETV/TDF+T101 No.2, ETV or TDF, ETV/TDF+Peg-IFNα-2b
Keywords
Hepatitis B Virus (HBV) infection
Medical subject headings
Hepatitis B, Infections

What participants receive

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

  • ETV/TDF+T101 No.1Biological

    Patients will be injected with T101 once on Day1 (Week0), Day8 (Week1), Day15 (Week2), Day106 (Week15), Day113 (Week16), Day120 (Week17), Day211 (Week30), Day218 (Week31), Day225 (Week32), Day316 (Week45), Day323 (Week46), Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.

  • ETV/TDF+T101 No.2Biological

    Patients will be injected with T101 once on Day1 (Week0), Day106 (Week15), Day211 (Week30), Day316 (Week45); ETV or TDF will be administrated once each day successively until Day420.

  • ETV or TDFBiological

    Patients will be administrated ETV or TDF once each day successively until Day420.

  • ETV/TDF+Peg-IFNα-2bBiological

    Patients will be administrated Peg-IFNα-2b successively once a week until Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.

Study groups in NCT04189276
Study groupRoleWhat they receive
Group1Active comparatorT101+ETV(Entecavir) /TDF(Tenofovir)
Receives: Biological: ETV/TDF+T101 No.1
Group2Active comparatorT101+ETV/TDF
Receives: Biological: ETV/TDF+T101 No.2
Group3Active comparatorETV or TDF
Receives: Biological: ETV or TDF
Group4Active comparatorPeg-IFNα-2b+ETV/TDF
Receives: Biological: ETV/TDF+Peg-IFNα-2b

What is being measured

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

  1. All the observed or reported AEs (adverse events)

    observe and record all the AEs of patients during the clinical trial and determine their correlation with the investigational medical product

    Measured: through study completion, an average of 60 weeks

  2. HBsAg change

    evaluate the HBsAg change from the baseline to evaluate the efficacy of T101

    Measured: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

Secondary outcomes (4)

  1. The percentage of Subjects' HBsAg decrease ≥ 1 log

    to evaluate the efficacy of T101

    Measured: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

  2. The percentage of Subjects' HBsAg decrease ≥ 0.5 log

    to evaluate the efficacy of T101

    Measured: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

  3. Negative convention rate of HBsAg

    to evaluate the efficacy of T101

    Measured: Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

  4. Positive convention rate of HBsAb

    to evaluate the efficacy of T101

    Measured: Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

Timeline

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

  1. First posted6 Dec 2019
  2. Study start10 Dec 2019
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completionDec 2021 (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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04189276
Sponsor's protocol ID
TSL-BM-T101-II
Status last verified
Feb 2021
First submitted
3 Nov 2019
Last updated
8 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ETV/TDF+T101 No.1, ETV/TDF+T101 No.2 and ETV or TDF in people with Hepatitis B Virus (HBV), run by Tasly Tianjin Biopharmaceutical Co., Ltd. at 3 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 7 inclusion and 20 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All the observed or reported AEs (adverse events) (time frame: through study completion, an average of 60 weeks). The study lists 2 primary outcomes in all. 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 NCT04189276.

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 8 Feb 2021.

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