Chronic Hepatitis BNCT02167503
Observational Study on Patients With Chronic Hepatitis B
An observational study of Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 14 sites in China.
Trial summary
The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 10,000 participants
- Where
- 14 sitesChina
- Study dates
- May 2014to May 2020
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis B from hospital
Who may be able to join
- Male or female, aged over 30 (inclusive) years of old
- Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months)
- For patients with HBsAg positive, patients should be undergoing anti-viral treatment
- For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided.
- Life expectancy is more than 1 year
- Good treatment compliance.
Who cannot join
- Patients has a history of diagnosis of hepatocellular carcinoma
- Patients with Child Pugh C
- Coinfected with HCV, HDV and HIV
- Suffering from other serious disease
- Taking part in other clinical trial
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Beijing Ditan Hospital
Beijing, Beijing Municipality
Jun Cheng, MD
Jun Cheng, MD
- Recruiting
Beijing Friendship Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality
Hong Ma, MD, 13651096128
hong ma, MD
- Recruiting
BeiJing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality
XinYue Chen, MD, 13911212398
XinYue Chen
- Recruiting
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality
Yanyan Yu, MD, 13901194223
Yanyan Yu, MD
- Recruiting
People's Hospital of Beijing University
Beijing, Beijing Municipality
Lai Wei, MD
Lai Wei, MD
- Recruiting
First Hospital .Jilin Unniversity
Changchun, Jilin
JunQi Niu, MD, 13756661205
JunQi Niu
- Recruiting
Xiangya Hospital Central-South Univrsity
Changsha, Hunan
DeMing Tan, MD, 13875986817
DeMing Tan, MD
- Recruiting
Department of infectious disease, Nanfang Hospital
Guangzhou, Guangdong, 510515
Jinlin Hou, MD
Jinlin Hou, MD
- Recruiting
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
ZhiLiang Gao, MD, 13902263533
ZhiLiang GAo
- Recruiting
The First Affiliated Hospital of College of Medicine ，Zhejiang University
Hangzhou, Zhejiang
JiFang Sheng, MD, 13600519200
JiFang Sheng
- Recruiting
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality
GuangFeng Shi, MD, 13817780666
GuangFeng Shi, MD
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality
Qing Xie, MD, 13651804273
Qing Xie
- Recruiting
ShengJing Hospital of China Medical University
Shenyang, Liaoning
XiaoGuang Dou, MD, 13898867074
XiaoGuang Dou
- Recruiting
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Qin Ning, 13971521450
Qin Ning
About this study
Official title: A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)
The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.
- Conditions
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rates of hepatocellular carcinoma
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167503
- Sponsor's protocol ID
- MOH-08
- Status last verified
- Jun 2014
- First submitted
- 17 Jun 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)
- ClinicalTrials.gov ID
- NCT02167503
- Acronym / sponsor ID
- MOH-08
- Conditions
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China
- Study start
- May 2014
- Primary completion
- May 2020 (estimated)
- First posted
- 19 Jun 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 study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis B from hospital
Key inclusion criteria (6 listed)
- Male or female, aged over 30 (inclusive) years of old
- Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months)
- For patients with HBsAg positive, patients should be undergoing anti-viral treatment
- For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided.
- Life expectancy is more than 1 year
Key exclusion criteria (5 listed)
- Patients has a history of diagnosis of hepatocellular carcinoma
- Patients with Child Pugh C
- Coinfected with HCV, HDV and HIV
- Suffering from other serious disease
- Taking part in other clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative rates of hepatocellular carcinoma
Time frame: Year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
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A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
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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.
Jinlin Hou, MD principal investigator
Nanfang Hospital, Southern Medical University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 14 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 6 inclusion and 5 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 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 Jinlin Hou, MD (86-20-61641941, jlhousmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative rates of hepatocellular carcinoma (time frame: Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2014; AzTrials last refreshed its copy on 3 Nov 2026.