Hepatitis B, ChronicPhase 4HBVNCT03485534
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
A Phase 4 study testing Tenofovir Disoproxil Fumarate and Tenofovir Disoproxil in people with Hepatitis B, Chronic, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Tenofovir Disoproxil Fumarate and Tenofovir Disoproxil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2018to 4 Nov 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
- HBeAg negative and HBeAb positive at screening
Who cannot join
- Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
- Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
- Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Significant renal, cardiovascular, pulmonary, or neurological disease
- currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.
In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks
Read the detailed description
Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase.
The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .
- Conditions
- Hepatitis B, Chronic
- Being tested
- Tenofovir Disoproxil Fumarate, Tenofovir Disoproxil
- 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 FumarateDrug
Also called Viread
Viread 300mg
Tenofovir DisoproxilDrug
Also called Virehepa
Virehepa 245mg
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir Disoproxil | Experimental | Tenofovir Disoproxil 245mg, a daily dose for 48 weeks Receives: Drug: Tenofovir Disoproxil |
| Tenofovir Disoproxil Fumarate | Placebo comparator | Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA inhibition
plasma HBV DNA level of less than 400 copies per milliliter
Measured: 48weeks
Secondary outcomes (1)
viral suppression
an HBV DNA level of <400 copies per milliliter
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start23 Jan 2018
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Open-label, randomized, Parallel
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- C&R Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Youngsuk Lim, PHD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485534
- Sponsor's protocol ID
- DW_TEN001
- Acronym
- HBV
- Status last verified
- Jun 2022
- First submitted
- 27 Mar 2018
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate
- ClinicalTrials.gov ID
- NCT03485534
- Acronym / sponsor ID
- HBV / DW_TEN001
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Collaborators
- C&R Research, Inc.
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.
In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks
Detailed description
Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase.
The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized, Parallel
| Arm | Type | Receives |
|---|---|---|
| Tenofovir Disoproxil | Experimental | Drug: Tenofovir DisoproxilTenofovir Disoproxil 245mg, a daily dose for 48 weeks |
| Tenofovir Disoproxil Fumarate | Placebo comparator | Drug: Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
- HBeAg negative and HBeAb positive at screening
Key exclusion criteria (5 listed)
- Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
- Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
- Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Significant renal, cardiovascular, pulmonary, or neurological disease
- currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil FumarateAlso: VireadViread 300mg | Drug | Tenofovir Disoproxil Fumarate |
| Tenofovir DisoproxilAlso: VirehepaVirehepa 245mg | Drug | Tenofovir Disoproxil |
Primary outcome
HBV DNA inhibition
Time frame: 48weeks
plasma HBV DNA level of less than 400 copies per milliliter
1 secondary outcome
viral suppression
Time frame: 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngsuk Lim, PHD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Disoproxil Fumarate and Tenofovir Disoproxil in people with Hepatitis B, Chronic, run by Daewoong 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 2 inclusion and 5 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 9 Jun 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. Some participants in this study may receive a placebo. 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?
HBV DNA inhibition (time frame: 48weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.