Hepatitis B, ChronicNCT03358108
A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)
An observational study of Hepatitis B, Chronic, run by Qin Ning at 11 sites in China.
Trial summary
This is a prospective, multicentre observational follow-up study of PegIFN treatment unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will join this study after finished following clinical trail about A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 1,600 participants
- Where
- 11 sitesChina
- Study dates
- 27 Feb 2018to 1 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor,NPGV studies, were included in the observational study after they finished.
Who may be able to join
- Male and female patients from 18 to 65 years of age;
- Have finished the OSST,COST,Endeavor, Anchor,NPGV studies;
- Agree to participate in the study and sign the patient informed consent.
Who cannot join
- patients have not participated in the OSST,Cost,Endeavor,Anchor or NPGV study ;
- unable or unwilling to provide informed consent or follow the research requirements
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
BeiJing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality
Chen Xinyue, Doctor
- Recruiting
Departmen of infectious disease, Xiangya Hospital, Central-south Universit
Changsha, Hunan
Tan Deming, Doctor
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Jiang Jiaji, Doctor
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
- Recruiting
The Second Hospital of Nanjing
Nanjing, Jiangsu
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
- Recruiting
Traditional Chinese Medicine,Xiamen Hospital
Shantou, Xiamen
- Recruiting
The first affiliated hospital of Wenzhou medical universtiy
Wenzhou, Zhejiang
Chen Yongping, Doctor
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Qin Ning, Ph.D. M.D., 86 27 83662391, qning@vip.sina.com
Meifang Han, Ph.D. M.D., 86 27 83662391, hanmeifang@hotmail.com
- Recruiting
The First Affiliated Hospital of College of Medicine, Zhejiang University
Zhejiang, Hangzhou, Doctor
Qi Xia
About this study
Official title: A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)
This is a prospective, multicentre observational follow-up study of PegIFN treatment unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will join this study after finished following clinical trail about A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B(OSST trail),A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B (COST study), Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients(Endeavor study),A Prospective Clinical Trial in Chronic Hepatitis B Patients Nucleotide Analogues Experienced (Anchor A Study),Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients (NPGV study).We plan to compare the HBsAg negative rate and maintenance rate,the occurrence of liver cirrhosis and the occurrence rate of hepatocellular carcinoma(HCC) related to hepatitis B virus(HBV) within five years between interferon group (including interferon alone or interferon combined with other drugs) and nucleoside analogues.Patients were divided into two groups based on whether they received interferon or not.
Read the detailed description
Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor NPGV studies, were included in the observational study after they finished. The patients entered the following two observation groups based on previous studies: Group A: formerly interferon group (including interferon alone or interferon combined with other drugs); Group B: formerly nucleoside analogue treatment group. Each group was followed for five years.All patients were followed up for physical examination (vital signs, whole body examination) and laboratory assessment (HBsAg quantification, HBeAg quantification, HBV DNA, HBV immunology marker, blood routine, blood biochemistry, alpha fetoprotein, Fibroscan, liver Doppler) in every six month.
- Conditions
- Hepatitis B, Chronic
- 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 group | Role | What they receive |
|---|---|---|
| Group A: interferon group | formerly interferon group (including interferon alone or interferon combined with other drugs) | |
| Group B:nucleoside analogue group | formerly nucleoside analogue treatment group. Each group was followed for five years |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBsAg negative at week 260
Compare the HBsAg negative rate at week 260 with that at baseline
Measured: week 260
Secondary outcomes (8)
The maintenance response rate of HBsAg negativity at week 260
the proportion of patients with sustained HBsAg negativity at week 260 among the patients whose HBsAg negative at baseline
Measured: week 260
HBsAg quantification decline from baseline to week 260
HBsAg quantification decline from baseline to week 260 are measured.
Measured: week 260
Change from baseline in HBsAg seroconversion at week 260
HBsAg seroconversion from baseline is measured
Measured: week 260
The rate of HBsAb positive at week 260
Compare the rate of HBsAb positive at week 260 with that at baseline
Measured: week 260
Measure the Fibroscan value
Fibroscan value from baseline is measured
Measured: week 260
the occurrence rate of liver cirrhosis
Statistics for occurrence rates of liver cirrhosis
Measured: week 260
the occurrence rate of HCC related to HBV
Statistics for occurrence rates of HCC related to HBV
Measured: week 260
The proportion of patients with HBV DNA <1000 copies / mL
Statistics the proportion of patients with HBV DNA <1000 copies / mL
Measured: week 260
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start27 Feb 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
- Investigators
- Ning Qin, Doctor, Principal investigator, Department of Infectious Diseases, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358108
- Sponsor's protocol ID
- OCEAN study
- Status last verified
- Oct 2018
- First submitted
- 20 Nov 2017
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)
- ClinicalTrials.gov ID
- NCT03358108
- Acronym / sponsor ID
- OCEAN study
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Nov 2017 (actual)
- 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.
This is a prospective, multicentre observational follow-up study of PegIFN treatment unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will join this study after finished following clinical trail about A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B(OSST trail),A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B (COST study), Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients(Endeavor study),A Prospective Clinical Trial in Chronic Hepatitis B Patients Nucleotide Analogues Experienced (Anchor A Study),Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients (NPGV study).We plan to compare the HBsAg negative rate and maintenance rate,the occurrence of liver cirrhosis and the occurrence rate of hepatocellular carcinoma(HCC) related to hepatitis B virus(HBV) within five years between interferon group (including interferon alone or interferon combined with other drugs) and nucleoside analogues.Patients were divided into two groups based on whether they received interferon or not.
Detailed description
Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor NPGV studies, were included in the observational study after they finished. The patients entered the following two observation groups based on previous studies: Group A: formerly interferon group (including interferon alone or interferon combined with other drugs); Group B: formerly nucleoside analogue treatment group. Each group was followed for five years.All patients were followed up for physical examination (vital signs, whole body examination) and laboratory assessment (HBsAg quantification, HBeAg quantification, HBV DNA, HBV immunology marker, blood routine, blood biochemistry, alpha fetoprotein, Fibroscan, liver Doppler) in every six month.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: interferon group | – | –formerly interferon group (including interferon alone or interferon combined with other drugs) |
| Group B:nucleoside analogue group | – | –formerly nucleoside analogue treatment group. Each group was followed for five years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor,NPGV studies, were included in the observational study after they finished.
Key inclusion criteria (3 listed)
- Male and female patients from 18 to 65 years of age;
- Have finished the OSST,COST,Endeavor, Anchor,NPGV studies;
- Agree to participate in the study and sign the patient informed consent.
Key exclusion criteria (2 listed)
- patients have not participated in the OSST,Cost,Endeavor,Anchor or NPGV study ;
- unable or unwilling to provide informed consent or follow the research requirements
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
The rate of HBsAg negative at week 260
Time frame: week 260
Compare the HBsAg negative rate at week 260 with that at baseline
8 secondary outcomes
The maintenance response rate of HBsAg negativity at week 260
Time frame: week 260
HBsAg quantification decline from baseline to week 260
Time frame: week 260
Change from baseline in HBsAg seroconversion at week 260
Time frame: week 260
The rate of HBsAb positive at week 260
Time frame: week 260
Measure the Fibroscan value
Time frame: week 260
the occurrence rate of liver cirrhosis
Time frame: week 260
the occurrence rate of HCC related to HBV
Time frame: week 260
The proportion of patients with HBV DNA <1000 copies / mL
Time frame: week 260
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
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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.
Ning Qin, Doctor principal investigator
Department of Infectious Diseases, Tongji Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Qin Ning at 11 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 3 inclusion and 2 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 Ning Qin, Doctor (862783662391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of HBsAg negative at week 260 (time frame: week 260). 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 Oct 2018.