Chronic Hepatitis BPhase 4NCT01926288
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
A Phase 4 study testing Entecavir maleate tablets, blank Baraclude tablets and Blank maleate entecavir tablets in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Entecavir maleate tablets, blank Baraclude tablets and Blank maleate entecavir tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 9 sitesChina
- Study dates
- Oct 2008to Mar 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- Aged 18 to 70 years old，male or female
- Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA> 105 copies/ml.
- 1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
- Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
- Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
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- WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
- Creatinine (Cr) ≤ 1.5 × ULN.
- If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
- Patients signed an informed consent form and compliance was good.
Who cannot join
- Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
- Patients with cirrhosis or liver cancer.
- Patients have participated in another therapeutic clinical trial in 3 months.
- Granulocyte count <1.5 × 109 / L, hemoglobin (HB)<100g / L, sera alpha-fetoprotein(AFP)> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
- Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
- Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
- Pregnant woman, lactating women or those who wre allergic for study drug.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Department of Infectious Diseases,Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing You An Hospital,Capital Medical University
Beijing, Beijing Municipality, 100054
The First Affiliated Hospital Of The Third Mililary Medical University
Chongqing, Chongqing Municipality, 400038
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Sichuan, 400010
West China Hospital Of Sichuan University
Chongqing, Sichuan, 400010
The First Affiliated Hospital Of Zhejiang University
Hangzhou, Zhejiang, 310003
The First Affiliated Hospital Of Nanjing Medical University
Nanjing, Jiangsu, 210029
Shanghai Jiaotong University Affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
- Conditions
- Chronic Hepatitis B
- Being tested
- Entecavir maleate tablets, blank Baraclude tablets, Blank maleate entecavir tablets, Baraclude tablets
- 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.
Entecavir maleate tabletsDrug
blank Baraclude tabletsDrug
Blank maleate entecavir tabletsDrug
Baraclude tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| HBeAg positive group | Other | Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Receives: Drug: Entecavir maleate tablets; Drug: blank Baraclude tablets; Drug: Blank maleate entecavir tablets; Drug: Baraclude tablets |
| HBeAg-negative group | Other | Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Receives: Drug: Entecavir maleate tablets; Drug: blank Baraclude tablets; Drug: Blank maleate entecavir tablets; Drug: Baraclude tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with baseline, decline of serum HBV-DNA in the value
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startOct 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Yan yan, doctor, Principal investigator, Department of Infectious Diseases,Peking University First HospitalShi Guang feng, doctor, Principal investigator, Huashan HospitalXie Qing, doctor, Principal investigator, Shanghai Jiaotong University Affiliated Ruijin HospitalTang Hong, doctor, Principal investigator, West China HospitalZhang Da zhi, doctor, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityMao Qing, doctor, Principal investigator, The First Affiliated Hospital Of The Third Mililary Medical UniversityNing Qin, doctor, Principal investigator, Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and TechnologyLi Jun, doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926288
- Sponsor's protocol ID
- CTTQ805-4
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu JH, Wang S, Zhang DZ, Yu YY, Si CW, Zeng Z, Xu ZN, Li J, Mao Q, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C. World J Clin Cases. 2022 Oct 6;10(28):10085-10096. doi: 10.12998/wjcc.v10.i28.10085.
PubMed 36246814Xu JH, Wang S, Xu ZN, Yu YY, Si CW, Zeng Z, Li J, Mao Q, Zhang DZ, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144. J Viral Hepat. 2017 Oct;24(10):877-884. doi: 10.1111/jvh.12710. Epub 2017 Aug 11.
PubMed 28345157Li N, Xu JH, Yu M, Wang S, Si CW, Yu YY. Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy. World J Gastroenterol. 2015 Nov 21;21(43):12421-9. doi: 10.3748/wjg.v21.i43.12421.
PubMed 26604649
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
- ClinicalTrials.gov ID
- NCT01926288
- Acronym / sponsor ID
- CTTQ805-4
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBeAg positive group | Other | Drug: Entecavir maleate tablets, Drug: blank Baraclude tablets, Drug: Blank maleate entecavir tablets, Drug: Baraclude tabletsEntecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . |
| HBeAg-negative group | Other | Drug: Entecavir maleate tablets, Drug: blank Baraclude tablets, Drug: Blank maleate entecavir tablets, Drug: Baraclude tabletsEntecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- Aged 18 to 70 years old，male or female
- Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA> 105 copies/ml.
- 1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
- Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
Key exclusion criteria (7 listed)
- Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
- Patients with cirrhosis or liver cancer.
- Patients have participated in another therapeutic clinical trial in 3 months.
- Granulocyte count <1.5 × 109 / L, hemoglobin (HB)<100g / L, sera alpha-fetoprotein(AFP)> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
- Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
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 |
|---|---|---|
| Entecavir maleate tablets | Drug | HBeAg positive group, HBeAg-negative group |
| blank Baraclude tablets | Drug | HBeAg positive group, HBeAg-negative group |
| Blank maleate entecavir tablets | Drug | HBeAg positive group, HBeAg-negative group |
| Baraclude tablets | Drug | HBeAg positive group, HBeAg-negative group |
Primary outcome
Compared with baseline, decline of serum HBV-DNA in the value
Time frame: 5 years
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 29 Dec 2017.
- Derived from this study: PubMed 36246814Xu JH, Wang S, Zhang DZ, Yu YY, Si CW, Zeng Z, Xu ZN, Li J, Mao Q, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C. World J Clin Cases. 2022 Oct 6;10(28):10085-10096. doi: 10.12998/wjcc.v10.i28.10085.
- Derived from this study: PubMed 28345157Xu JH, Wang S, Xu ZN, Yu YY, Si CW, Zeng Z, Li J, Mao Q, Zhang DZ, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144. J Viral Hepat. 2017 Oct;24(10):877-884. doi: 10.1111/jvh.12710. Epub 2017 Aug 11.
- Derived from this study: PubMed 26604649Li N, Xu JH, Yu M, Wang S, Si CW, Yu YY. Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy. World J Gastroenterol. 2015 Nov 21;21(43):12421-9. doi: 10.3748/wjg.v21.i43.12421.
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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.
Yu Yan yan, doctor principal investigator
Department of Infectious Diseases,Peking University First Hospital
Shi Guang feng, doctor principal investigator
Huashan Hospital
Xie Qing, doctor principal investigator
Shanghai Jiaotong University Affiliated Ruijin Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir maleate tablets, blank Baraclude tablets and Blank maleate entecavir tablets in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 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 10 inclusion and 7 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
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?
Compared with baseline, decline of serum HBV-DNA in the value (time frame: 5 years). 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 NCT01926288, which also lists 3 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 29 Dec 2017.