Hepatitis CNCT01594554
A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
An observational study of Hepatitis C, run by Peking University People's Hospital at 1 site in China.
Trial summary
A 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 600
Who may be able to join
- None. Patients from AI452-009 study who accepted ICF to be follow up
Who cannot join
- < 18 years old not Han ethnic Not be willing to be followed up to 5 years
Trial locations and contacts
1 site in 1 country.
Lai Wei, Prof contact
China1 site, 1 recruiting
- Recruiting
Wei Lai
Beijing, Beijing Municipality, 100044
Wei Lai, MD, weelai@163.com
Li Hong, Ph. D.
About this study
Official title: A 5-year Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Real World Clinical Practice for Patients of Newly Confirmed HCV Infection in China (2012-2016)
A 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.
Read the detailed description
A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). In the AI452-009 study, all patients had a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study (AI452-018, CCgenos follow up phase, ClinicalTrials.gov Identifier: NCT01293279) is to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.
- Conditions
- Hepatitis C
- Keywords
- HCV viral genotypes, host genotypes, IL28B, Outcome, Follow-Up, ITPA, RNA, China
- Medical subject headings
- 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 Patients | A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA level
- HCV RNA level when on HCV treatments
Measured: 5 years
Secondary outcomes (4)
Subjects ratio of cirrhosis, HCC and death
- Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options
Measured: 5 years
Viral genotypes of subjects
Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime
Measured: 5 years
Host genotypes of subjects
Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime
Measured: 5 years
Diabetes status of subjects
Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Lai Wei, Peking University People's Hospital
- Investigators
- Hong Li, Ph.D, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594554
- Sponsor's protocol ID
- AI452018 ST
- Other IDs
- CCgenos Follow-up phase
- Status last verified
- May 2012
- First submitted
- 4 Apr 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang R, Shang J, Chen H, Li J, Xie Q, Feng J, Wei L, Rao H. Sustained virologic response improved the long-term health-related quality of life in patients with chronic hepatitis C: a prospective national study in China. BMC Infect Dis. 2024 Jan 10;24(1):72. doi: 10.1186/s12879-023-08940-3.
PubMed 38200419Wu N, Rao HY, Yang WB, Gao ZL, Yang RF, Fei R, Gao YH, Jin Q, Wei L. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chin Med J (Engl). 2020 Feb 5;133(3):253-261. doi: 10.1097/CM9.0000000000000629.
PubMed 31934936Rao H, Xie Q, Shang J, Gao Z, Chen H, Sun Y, Jiang J, Niu J, Zhang L, Wang L, Zhao L, Li J, Yang R, Zhu S, Li R, Wei L. Real-world clinical outcomes among individuals with chronic HCV infection in China: CCgenos study. Antivir Ther. 2019;24(7):473-483. doi: 10.3851/IMP3334.
PubMed 31566575
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Real World Clinical Practice for Patients of Newly Confirmed HCV Infection in China (2012-2016)
- ClinicalTrials.gov ID
- NCT01594554
- Acronym / sponsor ID
- AI452018 ST
- Conditions
- Hepatitis C
- Keywords
- HCV viral genotypes, host genotypes, IL28B, Outcome, Follow-Up, ITPA, RNA, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2012
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 9 May 2012 (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.
A 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.
Detailed description
A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). In the AI452-009 study, all patients had a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study (AI452-018, CCgenos follow up phase, ClinicalTrials.gov Identifier: NCT01293279) is to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV Patients | – | –A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 600
Key inclusion criteria (1 listed)
- None. Patients from AI452-009 study who accepted ICF to be follow up
Key exclusion criteria (1 listed)
- < 18 years old not Han ethnic Not be willing to be followed up to 5 years
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
HCV RNA level
Time frame: 5 years
• HCV RNA level when on HCV treatments
4 secondary outcomes
Subjects ratio of cirrhosis, HCC and death
Time frame: 5 years
Viral genotypes of subjects
Time frame: 5 years
Host genotypes of subjects
Time frame: 5 years
Diabetes status of subjects
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- Derived from this study: PubMed 38200419Huang R, Shang J, Chen H, Li J, Xie Q, Feng J, Wei L, Rao H. Sustained virologic response improved the long-term health-related quality of life in patients with chronic hepatitis C: a prospective national study in China. BMC Infect Dis. 2024 Jan 10;24(1):72. doi: 10.1186/s12879-023-08940-3.
- Derived from this study: PubMed 31934936Wu N, Rao HY, Yang WB, Gao ZL, Yang RF, Fei R, Gao YH, Jin Q, Wei L. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chin Med J (Engl). 2020 Feb 5;133(3):253-261. doi: 10.1097/CM9.0000000000000629.
- Derived from this study: PubMed 31566575Rao H, Xie Q, Shang J, Gao Z, Chen H, Sun Y, Jiang J, Niu J, Zhang L, Wang L, Zhao L, Li J, Yang R, Zhu S, Li R, Wei L. Real-world clinical outcomes among individuals with chronic HCV infection in China: CCgenos study. Antivir Ther. 2019;24(7):473-483. doi: 10.3851/IMP3334.
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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.
Lai Wei, Prof contact
Hong Li, Ph.D study director
Bristol-Myers Squibb
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 C, run by Peking University People's Hospital 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 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: status not confirmed, as of the sponsor's last update on 10 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lai Wei, Prof (weelai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV RNA level (time frame: 5 years). 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 NCT01594554, which also lists 3 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 10 May 2012.