Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48Phase 3NCT03236610

Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir

A Phase 3 study testing tenofovir monotherapy and tenofovir plus entecavir combination in people with Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48, run by Uijeongbu St. Mary Hospital at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 19 years and older
Conditions the study is for: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
What is being tested?: tenofovir monotherapy and tenofovir plus entecavir combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteSouth Korea
Study dates: 1 Jan 2016to 30 Jun 2019
Phase: Phase 3
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

HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM(rtL180M and/or M204V/I) \& ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months

Who cannot join

Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

Uijeongbu St. Mary Hospital
Uijongbu
Chang Wook Kim, 82318203997, cwkim@catholic.ac.kr
Recruiting

Other trials in South Korea

About this study

Official title: Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized Open-label Controlled Trial

Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
Being tested: tenofovir monotherapy, tenofovir plus entecavir combination

What participants receive

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

tenofovir monotherapyDrug
switching to tenofovir monotherapy
tenofovir plus entecavir combinationDrug
continuing tenofovir plus entecavir

Study groups in NCT03236610
Study group	Role	What they receive
tenofovir	Experimental	Not described Receives: Drug: tenofovir monotherapy
tenofovir plus entecavir	Active comparator	Not described Receives: Drug: tenofovir plus entecavir combination

What is being measured

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

SVR at week 48
Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48
Measured: 48 week

Timeline

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

1 Jan 201630 Jun 2019

First posted2 Aug 2017
Study start1 Jan 2016
Primary completion30 Jun 2018 (estimated)
Study completion30 Jun 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48Studies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03236610
Sponsor's protocol ID: XC15MIMI0100U
Status last verified: Jul 2017
First submitted: 28 Jul 2017
Last updated: 2 Aug 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized Open-label Controlled Trial
ClinicalTrials.gov ID: NCT03236610
Acronym / sponsor ID: XC15MIMI0100U
Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 112 participants (estimated)
Lead sponsor: Uijeongbu St. Mary HospitalUniversity, hospital or other
Study start: 1 Jan 2016 (actual)
Primary completion: 30 Jun 2018 (estimated)
Study completion: 30 Jun 2019 (estimated)
First posted: 2 Aug 2017 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
tenofovir	Experimental	Drug: tenofovir monotherapy
tenofovir plus entecavir	Active comparator	Drug: tenofovir plus entecavir combination

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM(rtL180M and/or M204V/I) \& ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months

Key exclusion criteria (1 listed)

Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

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 monotherapyswitching to tenofovir monotherapy	Drug	tenofovir
tenofovir plus entecavir combinationcontinuing tenofovir plus entecavir	Drug	tenofovir plus entecavir

Primary outcome

SVR at week 48
Time frame: 48 week
Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.

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.

Uijeongbu St. Mary Hospital

Uijongbu, South Korea

82318203997

cwkim@catholic.ac.kr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 2 Aug 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SVR at week 48 (time frame: 48 week). 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 NCT03236610.

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 2 Aug 2017.