Hepatitis BPhase 4NCT00222664
Qidong Hepatitis B Intervention Study
A Phase 4 study testing Hep-V Vax in people with Hepatitis B and Liver Neoplasms, run by University of Oxford at 3 sites in 2 countries.
Trial summary
During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hepatitis B, Liver Neoplasms, Liver Diseases
- What is being tested?
- Hep-V Vax
- How many people
- 80,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 1983to Dec 2004
- 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 0 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- all infants born in Qidong between September 1983 and November 1990
Who cannot join
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Cancer Institute, Chinese Academy of Medical Sciences
Beijing
Qidong Liver Cancer Institute
Qidong, Jiangsu
United Kingdom1 site
Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, OX3 7LF
About this study
During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.
- Conditions
- Hepatitis B, Liver Neoplasms, Liver Diseases
- Being tested
- Hep-V Vax
- Keywords
- hepatitis B, hepatocellular carcinoma, prevention, vaccination
- Medical subject headings
- Hepatitis B, Liver Neoplasms, Liver Diseases, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hep-V VaxBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 1983
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80,000 participants
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Qidong Liver Cancer Institute, Merck Institute for Therapeutic Research
- Investigators
- Zongtang Sun, MD, Study director, Cancer Institute and Hospital, Chinese Academy of Medical SciencesRichard Peto, Msc, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222664
- Sponsor's protocol ID
- Qidong-HBV-Study
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Sun Z, Zhu Y, Stjernsward J, Hilleman M, Collins R, Zhen Y, Hsia CC, Lu J, Huang F, Ni Z, et al. Design and compliance of HBV vaccination trial on newborns to prevent hepatocellular carcinoma and 5-year results of its pilot study. Cancer Detect Prev. 1991;15(4):313-8.
PubMed 1665400
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qidong Hepatitis B Intervention Study
- ClinicalTrials.gov ID
- NCT00222664
- Acronym / sponsor ID
- Qidong-HBV-Study
- Conditions
- Hepatitis B, Liver Neoplasms, Liver Diseases
- Keywords
- hepatitis B, hepatocellular carcinoma, prevention, vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80,000 participants
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Qidong Liver Cancer Institute, Merck Institute for Therapeutic Research
- Study start
- Sep 1983
- Study completion
- Dec 2004
- First posted
- 22 Sep 2005 (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.
During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all infants born in Qidong between September 1983 and November 1990
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Hep-V Vax | Biological | – |
Primary outcome
Not reported in the source record.
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 22 Sep 2005.
- Results publication: PubMed 1665400Sun Z, Zhu Y, Stjernsward J, Hilleman M, Collins R, Zhen Y, Hsia CC, Lu J, Huang F, Ni Z, et al. Design and compliance of HBV vaccination trial on newborns to prevent hepatocellular carcinoma and 5-year results of its pilot study. Cancer Detect Prev. 1991;15(4):313-8.
Related trials for Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Not yet recruitingPhase 1
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
Chronic Hepatitis B Virus
Recruiting
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Hepatitis B, Vaccination; Infection
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.
Zongtang Sun, MD study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Richard Peto, Msc study director
University of Oxford
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hep-V Vax in people with Hepatitis B and Liver Neoplasms, run by University of Oxford at 3 sites in 2 countries.
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 1 inclusion and 1 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 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, United Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222664, which also lists 1 linked publication.
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 22 Sep 2005.