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Chronic Hepatitis BEVOLVENCT01726439

Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China

An observational study of Chronic Hepatitis B, run by Bristol-Myers Squibb at 54 sites in China.

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

To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis B
How many people
3,434 participants
Where
54 sitesChina
Study dates
Dec 2012to 31 Dec 2018
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following: * Hospitals where 300 or more CHB patients are treated monthly * Hospitals where PCR can be performed in the hospital's laboratory to measure HBV DNA serum levels

Who may be able to join

  • CHB patients, or CHB patients with compensated cirrhosis, as defined by the current Chinese guidelines
  • Male or female
  • ≥ 18 years of age
  • Either Hepatitis B e antigen (HBeAg) positive or negative
  • Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient self-report)
  • Has compensated liver disease
Show all 9Show fewer
  • Patients with compensated cirrhosis
  • Patients who consent to participate in this study
  • Local residents with medical reimbursement coverage preferred

Who cannot join

  • Co-infected with hepatitis C virus (HCV)
  • CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase
  • CHB patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study
  • CHB patients with a confirmed pregnancy

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

China54 sites

  • Local Institution

    Baoding, Hebei, 071000

  • Local Institution

    Beijing, Beijing Municipality, 100050

  • Local Institution

    Changchun, Jilin, 130000

  • Local Institution

    Changsha, Hunan, 410006

  • Local Institution

    Changsha, Hunan, 410008

  • Local Institution

    Changsha, Hunan, 410013

  • Local Institution

    Changshu, Jiangsu, 215500

  • Local Institution

    Changzhou, Jiangsu, 213001

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Chengdu, Sichuan, 610072

  • Local Institution

    Chongqing, Chongqing Municipality, 400038

  • Local Institution

    Chongqing, Chongqing Municipality, 710032

  • Local Institution

    Dalian, Liaoning, 116001

  • Local Institution

    Daqing, Heilongjiang, 163461

  • Local Institution

    Foshan, Guangdong, 528000

  • Local Instution

    Fushun, Liaoning, 113000

  • Local Institution

    Fuzhou, Fujian, 350000

  • Local institution

    Guiyang, Guizhou, 550000

  • Local Institution

    Guiyang, Guizhou, 55000

  • Local Institution

    Haerbin, Heilongjiang, 150086

  • Local Institution

    Haikou, Hainan, 570100

  • Local institution

    Hangzhou, Zhejiang, 310000

  • Local Institution

    Hangzhou, Zhejiang, 310006

  • Local Institution

    Hangzhou, Zhejiang, 310023

  • Local Institution

    Jinan, Shandong, 250000

  • Local Institution

    Jinghua, Zhejiang, 300000

  • Local Institution

    Nangchang, Jiangxi, 330006

  • Local Institution

    Nanjing, Jiangsu, 210000

  • Local Institution

    Nanning, Guangxi, 530000

  • Local Institution

    Ningbo, Zhejiang, 315010

  • Local Institution

    Ordos, Inner Mongolia, 17000

  • Local Institution

    Qingdao, Shandong, 266000

  • Local Institution

    Quanzhou, Fujian, 362002

  • Local Institution

    Shengyang, Liaoning

  • Local Institution

    Shenyang, Liaoning, 110006

  • Local Institution

    Shenzhen, Guangdong, 528000

  • Local Institution

    Shijiazhuang, Hebei, 050000

  • Local Institution

    Shiyan, Hubei, 430000

  • Local Institution

    Suzhou, Jiangsu, 215000

  • Local Institution

    Taiyuan, Shanxi, 030000

  • Local Institution

    Taiyuan, Shanxi, 30000

  • Local Institution

    Tianjin, Tianjin Municipality, 300000

  • Local Institution

    Ürümqi, Xinjiang, 830001

  • Local Institution

    Ürümqi, Xinjiang, 830052

  • Local Institution

    Wuhan, Hubei, 430022

  • Local Institution

    Wuhan, Hubei, 430032

  • Local Institution

    Xi’an, Shanxi, 710032

  • Local Institution

    Xi’an, Shanxi, 710061

  • Local Institution

    Xiamen, Fujian, 1361009

  • Local institution

    Yanji, Jilin, 133000

  • Local Institution

    Yantai, Shandong, 264001

  • Local Institution

    Yinchuan, Ningxia, 750000

  • Local Institution

    Zhengzhou, Henan, 430000

  • Local Institution

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A 5-year Prospective and Observational Study to Evaluate the Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Chronic Hepatitis B (CHB) Patients Naive to NUC in Real World Practice at Hospitals in Tier 2 Cities in China (the EVOLVE Study)

To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study

Read the detailed description

Sampling Method: Consecutive patient sampling

Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study

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.

Study groups in NCT01726439
Study groupRoleWhat they receive
CHB patients who are naive to NUC treatmentCHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China

What is being measured

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

  1. Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy

    Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) < 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory

    Measured: 48 weeks after initial NUC antiviral therapy

Secondary outcomes (6)

  1. Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)

    Measured: Baseline (Day 1) and 48 weeks

  2. Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)

    Measured: 24 weeks and 96 weeks

  3. Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options

    Measured: 24 weeks, 48 weeks and 96 weeks

  4. Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment

    HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory

    Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

  5. Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance

    Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

  6. Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms

    Measured: 48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

Timeline

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

  1. First posted15 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01726439
Sponsor's protocol ID
AI463-952
Acronym
EVOLVE
Status last verified
Jul 2020
First submitted
6 Nov 2012
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • Jia J, Shang J, Tang H, Jiang J, Ning Q, Dou X, Zhang S, Zhang M, Han T, Tan D, Zhou X, Chen G, Sheng J, Su Z, Chen H, Dai E, Ye Y, Guo Y, Shen Y, Yuan J, Wei Z, Zhu S; EVOLVE Study Group. Long-term outcomes in Chinese patients with chronic hepatitis B receiving nucleoside/nucleotide analogue therapy in real-world clinical practice: 5-year results from the EVOLVE study. Antivir Ther. 2020;25(6):293-304. doi: 10.3851/IMP3372.

    PubMed 33090970

  • Jia J, Tang H, Ning Q, Jiang J, Dou X, Zhang M, Zhang S, Shang J, Lu W, Ye Y, Wang X, Li M, Liu J, Bo Q, Tan W; EVOLVE Study Group. Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results. Antivir Ther. 2018;23(3):201-209. doi: 10.3851/IMP3205.

    PubMed 29116050

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis B, run by Bristol-Myers Squibb at 54 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 9 inclusion and 4 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 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.

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?

Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy (time frame: 48 weeks after initial NUC antiviral therapy). 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 NCT01726439, which also lists 2 linked publications.

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 15 Jul 2020.

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