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Hepatitis B, ChronicPhase 4NCT02826070

EFFORT Further Extension Study

A Phase 4 study testing Telbivudine, Adefovir dipivoxil and off-treatment follow-up in people with Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 20 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Telbivudine, Adefovir dipivoxil and off-treatment follow-up
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
20 sitesChina
Study dates
Apr 2015to Oct 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients who completed EFFORT extension study.
  • Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA <9 Log copies/mL and ALT ≥2×ULN.
  • Patients who are willing to participate in the further extension study.
  • Patient is willing and able to comply with the study drug regimen and all other study requirements.
  • Patients must give written informed consent before any assessment is performed.

Who cannot join

  • 1. Poor compliance judged by investigators

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • 302 Military Hospital Of China

    Beijing, Beijing Municipality

  • Beijing Ditan Hospital

    Beijing, Beijing Municipality

  • BeiJing YouAn Hospital ,Capital Medical University

    Beijing, Beijing Municipality

  • Department of infectious disease, First Hospital of Peking University

    Beijing, Beijing Municipality

  • People's Hospital of Beijing University

    Beijing, Beijing Municipality

  • First Hospital .Jilin Unniversity

    Changchun, Jilin

  • Xiangya Hospital Central-South Univrsity

    Changsha, Hunan

  • The Second Affiliated of ChongQing University of Medical Science

    Chongqing, Chongqing Municipality

  • Department of Infectious Disease, Nanfang Hospital

    Guangzhou, Guangdong

  • No. 8 People's Hospital In GuangZhou

    Guangzhou, Guangdong

  • The Third Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • JiNan Infectious Diseases Hospital

    Jinan, Shandong

  • No.81 Hospital of PLA

    Nanjing, Jiangsu

  • Changhai Hospital affiliated to Second Military Medical University

    Shanghai, Shanghai Municipality

  • Huashan Hospital，Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality

  • ShengJing Hospital of China Medical University

    Shengyang, Liaoning

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Tangdu Hospital

    XiAn, Shanxi

Other trials in China

About this study

Official title: Efficacy of Long-term Telbivudine Treatment on Histological Improvements in Patients With Chronic Hepatitis B (EFFORT Further Extension Study)

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.

Being tested
Telbivudine, Adefovir dipivoxil, off-treatment follow-up
Keywords
Chronic Hepatitis B
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.

  • TelbivudineDrug

    Telbivudine, 600mg, oral, daily

  • Adefovir dipivoxilDrug

    Adefovir dipivoxil 10mg, oral, daily

  • off-treatment follow-upOther

Study groups in NCT02826070
Study groupRoleWhat they receive
Off-treatmentOtherPatients who had stopped treatment during EFFORT extension study could receive 2-year off-treatment follow-up. All the patients in Part I will be followed up at the interval of 12 weeks. For these patients, if they have hepatitis flare during follow-up, they will be re-treated with telbivudine combined with adefovir for the left study period ( the total study period is 2 years) and followed up at the interval of 12 weeks. Hepatitis flare is defined as HBV DNA>4 Log10 copies/mL with either ALT≥5 times upper limit of normal (ULN) or TBIL≥2×ULN，or 2 ≤ALT ≤5 ×ULN (at two consecutive visits at least 2 weeks apart) and total bilirubin (TBIL) <2×ULN.
Receives: Other: off-treatment follow-up
On-treatmentOtherPatients with continuous treatment during EFFORT extension study will continue treatment, without off-treatment rule in the further extension study. The treatment strategy is depended on the HBV DNA level of each individual, that is, for patients with negative HBV DNA level (defined as HBV DNA <20 IU/mL) will continue their previous treatment strategy; and for patients with positive HBV DNA level (defined as HBV DNA>=20 IU/mL) will receive the combination therapy of telbivudine and adefovir, irrespective of their previous treatment strategy. All the patients in Part II will be followed up at the interval of 24 weeks until they complete the 2-year on-treatment follow-up. Patients will be conducted liver biopsy at the sixth year of treatment. All the patients with telbivudine monotherapy will be switched to telbivudine plus adefovir once confirmed HBV DNA breakthrough developed.
Receives: Drug: Telbivudine; Drug: Adefovir dipivoxil

What is being measured

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

  1. Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score).

    Measured: Week 48

Secondary outcomes (12)

  1. Percentage of patients achieving hepatitis B virus (HBV) DNA <300copies/mL at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  2. Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  3. Percentage of patients with HBsAg loss or HBsAg seroconversion at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  4. The percentage of patients with alanine aminotransferase (ALT) normalization at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  5. Percentage of patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  6. Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  7. Incidence of adverse effect at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  8. Percentage of patients with glomerular filtration rate (GFR) shifting to >90 mL/min/1.73 m2 for patients with GFR <90 mL/min/1.73 m2 at baseline of EFFORT study at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  9. Sustained response rate of durability of HBeAg seroconversion at week 48 and 96 in off-treatment group

    Measured: week 48, week 96

  10. Percentage of patients who re-achieved ALT normalization and HBV DNA <300 copies/mL in the patients retreated who developed hepatitis flare after stopping treatment in off-treatment group

    Measured: week 96

  11. Incidence of abnormal laboratory examination at week 48 and 96 in on-treatment group

    Measured: week 48, week 96

  12. Percentage of hepatitis flare at week 48 and 96 in off-treatment group

    Measured: week 48, week 96

Timeline

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

  1. First posted7 Jul 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2016 (estimated)
  4. Study completionOct 2017 (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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02826070
Sponsor's protocol ID
MOH-09
Status last verified
Jun 2016
First submitted
27 Jun 2016
Last updated
7 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telbivudine, Adefovir dipivoxil and off-treatment follow-up in people with Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 20 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 5 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 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?

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?

Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score). (time frame: Week 48). 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 NCT02826070.

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 7 Jul 2016.

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