HepatitisHCVESNCT04593355
HCV Epidemiological Survey in China Rural Area
An observational study of Hepatitis, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatitis
- How many people
- 6,068 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Sep 2012
- How long will I take part?
- 5 Years
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are from the northeast of China. Most of the patients have been infected by the hepatitis c virus due to the drug abuse. Many of them share the same syringe for drug intravenous injection. However, HIV infection has been rarely detected.
Who may be able to join
- aged from 20 to 65
Who cannot join
- Has history of decompensated liver diseases
- Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
- Has a history of autoimmune hepatitis
- History of a severe seizure disorder or current anticonvulsant use
- History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HCV Epidemiological Survey of Chinese in Northeast Rural Area Which Have Injection History
The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population.
Read the detailed description
Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. More importantly, many of those patients with chronic hepatitis C eventually develop cirrhosis and hepatocellular carcinoma(HCC).Our survey found the rate of hepatitis c infection in northeastern China without intervention is 34.3%, due to the abuse of caffeine sodium benzoate. This population has the similar mode of transmission, which is a fine study of the natural outcome hepatitis C. We plan to carry out epidemiological studies for this population, review of the influencing factors of the disease, and analyze the host factors that can effect the prognosis.
- Conditions
- Hepatitis
- Keywords
- Predict, Hepatitis C Virus, Metabolomics
- Medical subject headings
- Hepatitis, Hepatitis C
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 |
|---|---|---|
| HCV | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Anti-HCV
Co-infection status are analyzed.
Measured: Baseline
Secondary outcomes (7)
Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)
ALT AST are assayed to detect the hepatic function.
Measured: Baseline
Fibrosis stage
Fibrosis is analyzed with Fibroscan.
Measured: Baseline
Regular blood test
The distribution and absolute count of the different types of blood cells are assayed.
Measured: Baseline
Blood HCV RNA Copies
Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.
Measured: Baseline
HCV genotype
HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.
Measured: Baseline
Drug abuse history
Patients will be asked about their drug usage history.
Measured: Baseline
Alcohol ,smoking condition
Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study startDec 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Time perspective
- Prospective
- Enrolment
- 6,068 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Principal investigator, Junqi Niu, The First Hospital of Jilin University
- Investigators
- Junqi Niu, PhD/MD, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593355
- Sponsor's protocol ID
- 20110101
- Acronym
- HCVES
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCV Epidemiological Survey of Chinese in Northeast Rural Area Which Have Injection History
- ClinicalTrials.gov ID
- NCT04593355
- Acronym / sponsor ID
- HCVES / 20110101
- Conditions
- Hepatitis
- Keywords
- Predict, Hepatitis C Virus, Metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,068 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- Dec 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Oct 2020 (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.
The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population.
Detailed description
Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. More importantly, many of those patients with chronic hepatitis C eventually develop cirrhosis and hepatocellular carcinoma(HCC).Our survey found the rate of hepatitis c infection in northeastern China without intervention is 34.3%, due to the abuse of caffeine sodium benzoate. This population has the similar mode of transmission, which is a fine study of the natural outcome hepatitis C. We plan to carry out epidemiological studies for this population, review of the influencing factors of the disease, and analyze the host factors that can effect the prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV | – | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are from the northeast of China. Most of the patients have been infected by the hepatitis c virus due to the drug abuse. Many of them share the same syringe for drug intravenous injection. However, HIV infection has been rarely detected.
Key inclusion criteria (1 listed)
- aged from 20 to 65
Key exclusion criteria (7 listed)
- Has history of decompensated liver diseases
- Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
- Has a history of autoimmune hepatitis
- History of a severe seizure disorder or current anticonvulsant use
- History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
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
Blood Anti-HCV
Time frame: Baseline
Co-infection status are analyzed.
7 secondary outcomes
Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)
Time frame: Baseline
Fibrosis stage
Time frame: Baseline
Regular blood test
Time frame: Baseline
Blood HCV RNA Copies
Time frame: Baseline
HCV genotype
Time frame: Baseline
Drug abuse history
Time frame: Baseline
Alcohol ,smoking condition
Time frame: Baseline
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 20 Oct 2020.
- Cooperator's homepageLink provided by the sponsor.
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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.
Junqi Niu, PhD/MD study chair
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, run by The First Hospital of Jilin University at 1 site 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 1 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Blood Anti-HCV (time frame: Baseline). 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 20 Oct 2020.