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Chronic Hepatitis BPhase 4NCT05282407

A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B

A Phase 4 study testing Tenofovir disoproxil 245mg and Tenofovir disoproxil fumarate 300mg in people with Chronic Hepatitis B, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase4, multicenter, open-label, randomized study to demonstrate that the Tenolid Tab switching group is non-inferior to the virologic suppression effect compared to the Viread Tab continuous administration group and evaluate the safety of Tenolid Tab. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Chronic Hepatitis B
What is being tested?
Tenofovir disoproxil 245mg and Tenofovir disoproxil fumarate 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteSouth Korea
Study dates
20 Nov 2017to 17 Apr 2019
Phase
Phase 4
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • As of the date of written consent, adults aged 19 or above
  • Patients with chronic hepatitis B
  • For chronic hepatitis B, Viread Tab. monotherapy† for more than 48 weeks, HBV suppression‡(virologic suppression) was confirmed, and it was determined that Tenofovir monotherapy for more than 48 weeks would be required.
  • † However, patients who take Viread Tab for more than 48 weeks before screening but do not take Viread Tab at the time of screening and discontinue the administration within 4 weeks until the time of randomization can be registered. (treatment gap ≤ 28 days)
  • HBV DNA < 400 copies/mL (=69 IU/mL*) * IU/mL is converting to copies/mL by unit for each institution. (Ex: 5.8 copies/mL = 1 IU/mL)
  • Subject who voluntarily consents to participate in the clinical trial and signs an informed consent

Who cannot join

  • Patients with liver cancer or decompensated liver cirrhosis* *Cirrhosis with clinical signs/symptoms of decompensation (jaundice, ascites, variceal bleeding, hepatic coma)
  • Patients with Hepatitis C virus (HCV), human immunodeficiency virus (HIV) with overlapping infections (HCV Ab positive, HIV Ab positive) However, if the HCV Ab or HIV Ab test result is judged to be 'false positive' by the investigator, HCV or HIV infection can be confirmed through additional confirmatory tests (HCV, HIV RNA test), etc.
  • Patients with other clinically significant liver disease (Hemochromatosis, Wilson's disease, Alcoholic liver disease, Autoimmune hepatitis, α-1 antitrypsin deficiency)
  • Patients confirmed by laboratory test results as followings
  • Severe anemia: Hemoglobin < 8g/dL ② Inadequate renal function: eGFR (Ccr, Cockcroft-Gault formula) < 50 mL/min ③ Inadequate hepatic function:
  • Total bilirubin > 3.0 mg/dL
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  • Albumin < 2.8 mg/dL
  • Prothrombin Time(PT) > INR 2.2
  • Patients with malignant tumors diagnosed within 5 years prior to screening However, in the case of basal cell carcinoma or squamouscell carcinoma of the skin, it is possible to participate in the clinical trial if it is judged to be 'cured' at the discretion of the investigator after surgery (treatment),.
  • Patients who are scheduled for an organ transplantation or who have undergone organ transplantation surgery
  • Patients with a history of clinically significant neuropsychiatric disorders, alcoholism, or drug dependence
  • Patients known to have hypersensitivity or allergy to components of investigational products or similar drugs
  • Patients who administered immunosuppressive drugs within 24 weeks prior to screening or who administered systemic corticosteroids over a limited dose (equivalent to prednisolone 10 mg/day) for 4 consecutive weeks or more.
  • Patients who are expected to require administration of the following drugs during the clinical trial period
  • ① Immunosuppressive drug
  • ② Systemic corticosteroids above a limited dose (equivalent to prednisolone 10 mg/day) for 2 consecutive weeks or more
  • ③ Drugs affecting renal excretion, drugs inducing nephrotoxicity or hepatotoxicity
  • ④ Anti-HBV drugs other than Tenofovir (ex. emtricitabine, lamivudine, telbivudine, clevudine, entecavir, interferone)
  • ⑤ Patients who administered hepatotonics at a stable dose for more than 3 months before screening can be registered.
  • Those who have a history of fractures requiring bone mineral density (BMD) monitoring or are at risk of osteopenia, who are judged unable to participate in clinical trials according to the investigator's judgment
  • For pregnant, lactating and reproductive women, patients who do not consent to contraception by a medically accepted method (surgical sterilization, intrauterine device, condom or diaphragm) during the clinical trial period
  • Patients who participated in another clinical trial within 12 weeks prior to screening and received investigational drugs or investigational devices.
  • In addition to the above, subject considered ineligible to participate in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab From Viread Tab in Chronic Hepatitis B Patients on Treatment With Tenofovir Disoproxil Fumarate

This is a Phase4, multicenter, open-label, randomized study to demonstrate that the Tenolid Tab switching group is non-inferior to the virologic suppression effect compared to the Viread Tab continuous administration group and evaluate the safety of Tenolid Tab. This clinical trial was conducted on patients who were taking Viread Tab as monotherapy for more than 48 weeks for chronic hepatitis B.

At the time of screening(Visit 1), information on factors related to medical history and prognosis including Viread Tab administration were collected retrospectively from the subjects who voluntarily signed the informed consent form (ICF). Only subjects who are determined to be suitable for the study eligibility(inclusion/exclusion) criteria as a result of the screening evaluations are randomized in a 1:1 ratio to one of the two groups at the baseline.

Subjects will receive investigational product start on the next day of randomization for 48 weeks. Subjects will visit to the study site on 12, 24, 36, 24 weeks after starting dosing investigational product and evaluated for effectiveness of virologic suppression and safety.

Being tested
Tenofovir disoproxil 245mg, Tenofovir disoproxil fumarate 300mg
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.

  • Tenofovir disoproxil 245mgDrug

    1 tablet q.d. for 48 weeks

  • Tenofovir disoproxil fumarate 300mgDrug

    1 tablet q.d. for 48 weeks

Study groups in NCT05282407
Study groupRoleWhat they receive
Experimental groupExperimentalTenolid Tab
Receives: Drug: Tenofovir disoproxil 245mg
Control groupActive comparatorViread Tab
Receives: Drug: Tenofovir disoproxil fumarate 300mg

What is being measured

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

  1. Inhibiting† rate of HBV virus at 48 weeks after baseline †HBV DNA < 400 copies/mL (=69 IU/mL*) *IU/mL is converting to copies/mL by unit for each institution. (ex: 5.8 copies/mL = 1 IU/mL)

    Measured: 48 weeks

Secondary outcomes (10)

  1. Inhibiting† rate of HBV virus at 12, 24 and 36 weeks after baseline †HBV DNA < 400 copies/mL (=69 IU/mL*) * IU/mL is converting to copies/mL by unit for each institution. (ex: 5.8 copies/mL = 1 IU/mL)

    Measured: 12, 24, and 36 weeks

  2. Undetected‡ rate of HBV virus at 12, 24, 36 and 48 weeks after baseline ‡ The lower limit of quantification (LLOQ) for each institution is used, and if it is less than the LLOQ, the HBV DNA level is set to '0'.

    Measured: 12, 24, 36 and 48 weeks

  3. Change of HBV DNA(log10 copies/mL) at 12, 24, 36 and 48 weeks from baseline

    Measured: 12, 24, 36 and 48 weeks

  4. Loss rate of HBeAg in HBeAg(+) patients at 12, 24, 36 and 48 weeks after baseline

    Measured: 12, 24, 36 and 48 weeks

  5. Seroconversion† rate of HBeAg in HBeAg(+) patients at 12, 24, 36 and 48 weeks after baseline †Generation of anti-HBe

    Measured: 12, 24, 36 and 48 weeks

  6. Loss rate of HBsAg in HBsAg(+) patients at 12, 24, 36 and 48 weeks after baseline

    Measured: 12, 24, 36 and 48 weeks

  7. Seroconversion† rate of HBsAg in HBsAg(+) patients at 12, 24, 36 and 48 weeks after baseline †Generation of anti-HBs

    Measured: 12, 24, 36 and 48 weeks

  8. Normal rate of ALT at 12, 24, 36 and 48 weeks after baseline

    Measured: 12, 24, 36 and 48 weeks

  9. Change of ALT at 12, 24, 36 and 48 weeks from baseline

    Measured: 12, 24, 36 and 48 weeks

  10. Virologic breakthrough* rate within 48 weeks after baseline *HBV DNA ≥ 400 copies/mL: twice in a row at intervals of 2 weeks or more or HBV DNA levels: increasing by 1log10 from Nadir levels of each subject twice in a row (HBV DNA <400 copies/mL)

    Measured: 48 weeks

Timeline

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

  1. First posted16 Mar 2022
  2. Study start20 Nov 2017
  3. Primary completion17 Apr 2019
  4. Study completion17 Apr 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282407
Sponsor's protocol ID
TNLD01
Status last verified
Feb 2022
First submitted
25 Feb 2022
Last updated
1 Apr 2022
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 4 study testing Tenofovir disoproxil 245mg and Tenofovir disoproxil fumarate 300mg in people with Chronic Hepatitis B, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.

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 23 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: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Inhibiting† rate of HBV virus at 48 weeks after baseline †HBV DNA < 400 copies/mL (=69 IU/mL*) *IU/mL is converting to copies/mL by unit for each institution. (ex: 5.8 copies/mL = 1 IU/mL) (time frame: 48 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 NCT05282407.

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 1 Apr 2022.

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