Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48Phase 3NCT03236584

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

A Phase 3 study testing lamivudine plus adefovir combination and Tenofovir Disoproxil Fumarate 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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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?: lamivudine plus adefovir combination and Tenofovir Disoproxil Fumarate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: No sites listed yet
Study dates: 1 Sep 2015to 30 Mar 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) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval

Who cannot join

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

About this study

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

Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
Being tested: lamivudine plus adefovir combination, Tenofovir Disoproxil Fumarate

What participants receive

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

lamivudine plus adefovir combinationDrug
continuing lamivudine plus adefovir
Tenofovir Disoproxil FumarateDrug
switching to tenofovir

Study groups in NCT03236584
Study group	Role	What they receive
lamivudine adefovir	Active comparator	Not described Receives: Drug: lamivudine plus adefovir combination
tenofovir	Experimental	Not described Receives: Drug: Tenofovir Disoproxil Fumarate

What is being measured

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

SVR
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 Sep 201530 Mar 2019

First posted2 Aug 2017
Study start1 Sep 2015
Primary completion30 Mar 2018 (estimated)
Study completion30 Mar 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: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03236584
Sponsor's protocol ID: UC15MISI0099
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
Individual data sharing: 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 Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial
ClinicalTrials.gov ID: NCT03236584
Acronym / sponsor ID: UC15MISI0099
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: 76 participants (actual)
Lead sponsor: Uijeongbu St. Mary HospitalUniversity, hospital or other
Study start: 1 Sep 2015 (actual)
Primary completion: 30 Mar 2018 (estimated)
Study completion: 30 Mar 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
lamivudine adefovir	Active comparator	Drug: lamivudine plus adefovir combination
tenofovir	Experimental	Drug: Tenofovir Disoproxil Fumarate

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) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval

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
lamivudine plus adefovir combinationcontinuing lamivudine plus adefovir	Drug	lamivudine adefovir
Tenofovir Disoproxil Fumarateswitching to tenofovir	Drug	tenofovir

Primary outcome

SVR
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.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

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.

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?

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?

SVR (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 NCT03236584.

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.