Chronic Hepatitis BNCT02287857
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
A study testing Domestic Tenofovir Disoproxil Fumarate Tablets and Tenofovir Disoproxil Fumarate Tablets of Gilead in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead. 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?
- Domestic Tenofovir Disoproxil Fumarate Tablets and Tenofovir Disoproxil Fumarate Tablets of Gilead
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 15 sitesChina
- Study dates
- Sep 2014to Oct 2019
- Phase
- Interventional
- 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
- The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- Aged 18 to 65 years old，male or female
- Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA> 105copies/ml； HBeAg-negative subjects, HBV-DNA> 104copies/ml.
- 2 times the upper normal limit (2 × 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 ≥ 80 × 109 / L, serum albumin (ALB)≥ 35 g / L.
- Creatinine (Cr) ≤ 1× ULN，serum phosphate was normal.
- Patients signed an informed consent form and compliance was good.
Who cannot join
- Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.
- Patients with cirrhosis or liver cancer.
- Pregnant woman, lactating women .
- Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
- Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
- Patients allergic for study drug.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015
Xiao hua Hao, doctor, 13466590802, xiaohualuck@sina.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Li qin Yu, doctor, 010-66119025, jgbgs090101@126.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Hao Wang, doctor, 010-88325988, jgbgs090101@126.com
- Recruiting
Beijing You An Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Mei xia Wang, doctor, 010-83997322, youangcp@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdou, Sichuan, 610041
Juan Liao, doctor, 15828323384, hxcrgcp@163.com
- Recruiting
First Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400039
Yong chuan Chen, doctor, 13883405537, zwmcyc@163.com
- Recruiting
Third Affiliated Hospital of Sun Yat-sen
Guangzhou, Guangdong, 510630
Qian Huang, doctor, 02085253153, sankyk@163.com
- Recruiting
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Li hua Wu, doctor, 13819195192
- Recruiting
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003
Yu Pan, doctor, 13814099474
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xu Huang, doctor, 02568136360, jsphkj@163.com
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yi feng Wang, doctor, 02154661789, ruijin_gcp@126.com
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Fei Dong, doctor, 02152888041
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Na Li, doctor, 18916082023, lina40125@shaphc.org
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xiu Jin, doctor, 13526660319
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Juan Li, doctor, 13526506270
About this study
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
- Conditions
- Chronic Hepatitis B
- Being tested
- Domestic Tenofovir Disoproxil Fumarate Tablets, Tenofovir Disoproxil Fumarate Tablets of Gilead
- 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.
Domestic Tenofovir Disoproxil Fumarate TabletsDrug
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
Tenofovir Disoproxil Fumarate Tablets of GileadDrug
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead
| Study group | Role | What they receive |
|---|---|---|
| Domestic Tenofovir Disoproxil Fumarate Tablets | Experimental | Not described Receives: Drug: Domestic Tenofovir Disoproxil Fumarate Tablets |
| Tenofovir Disoproxil Fumarate Tablets of Gilead | Active comparator | Not described Receives: Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead |
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: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan yan Yu, doctor, Principal investigator, Peking University First HospitalHao Wang, doctor, Principal investigator, Peking University People's HospitalJun Chen, doctor, Principal investigator, Beijing Ditan HospitalXin yue Chen, doctor, Principal investigator, Beijing You An Hospital, Capital Medical UniversityWen hong Zhang, doctor, Principal investigator, Huashan HospitalQing Xie, doctor, Principal investigator, Ruijin HospitalShan ming Wu, doctor, Principal investigator, Shanghai Public Health Clinical CenterHong Tang, doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287857
- Sponsor's protocol ID
- CTTQ-TDF-V4.0
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2014
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen XF, Fan YN, Si CW, Yu YY, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Xu JH. Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks. World J Clin Cases. 2021 Jun 26;9(18):4690-4699. doi: 10.12998/wjcc.v9.i18.4690.
PubMed 34222435Liang RY, Xu JH, Si CW, Wang S, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Yu YY. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778.
PubMed 31415381
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02287857
- Acronym / sponsor ID
- CTTQ-TDF-V4.0
- Conditions
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 11 Nov 2014 (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 Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Domestic Tenofovir Disoproxil Fumarate Tablets | Experimental | Drug: Domestic Tenofovir Disoproxil Fumarate Tablets |
| Tenofovir Disoproxil Fumarate Tablets of Gilead | Active comparator | Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- Aged 18 to 65 years old，male or female
- Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA> 105copies/ml； HBeAg-negative subjects, HBV-DNA> 104copies/ml.
- 2 times the upper normal limit (2 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
- Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
Key exclusion criteria (6 listed)
- Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.
- Patients with cirrhosis or liver cancer.
- Pregnant woman, lactating women .
- Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
- Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
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 |
|---|---|---|
| Domestic Tenofovir Disoproxil Fumarate Tablets1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead | Drug | Domestic Tenofovir Disoproxil Fumarate Tablets |
| Tenofovir Disoproxil Fumarate Tablets of Gilead1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead | Drug | Tenofovir Disoproxil Fumarate Tablets of Gilead |
Primary outcome
Compared with baseline, decline of serum HBV-DNA in the value
Time frame: 48 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Derived from this study: PubMed 34222435Chen XF, Fan YN, Si CW, Yu YY, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Xu JH. Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks. World J Clin Cases. 2021 Jun 26;9(18):4690-4699. doi: 10.12998/wjcc.v9.i18.4690.
- Derived from this study: PubMed 31415381Liang RY, Xu JH, Si CW, Wang S, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Yu YY. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778.
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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.
Yan yan Yu, doctor principal investigator
Peking University First Hospital
Hao Wang, doctor principal investigator
Peking University People's Hospital
Jun Chen, doctor principal investigator
Beijing Ditan Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domestic Tenofovir Disoproxil Fumarate Tablets and Tenofovir Disoproxil Fumarate Tablets of Gilead in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 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 6 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan yan Yu, doctor (13901194223, yyy@bjnu.edu), or a site near the patient. 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: 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 NCT02287857, 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 19 Mar 2019.