Hepatitis C, ChronicNCT02011932
Prospective Observational Study of Disease Progression in Chronic Hepatitis C
An observational study of Hepatitis C, Chronic and Disease Progression, run by Beijing YouAn Hospital.
Trial summary
The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic, Disease Progression, Liver Cirrhosis
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The plasma donors were primarily chosen from healthy farmers and agricultural workers living in a remote small city in the Northwest China.
Who may be able to join
- All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.
- The Hepatitis C Virus antibody was positive.
- All patients did not receive interferon therapy before being recruited.
Who cannot join
- Patients with evidences for other forms of liver diseases.
- The coinfection with hepatitis B virus or other virus.
About this study
Official title: Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation
The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.
- Conditions
- Hepatitis C, Chronic, Disease Progression, Liver Cirrhosis
- Medical subject headings
- Hepatitis C, Chronic, Disease Progression, Liver Cirrhosis
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 |
|---|---|---|
| Healthy volunteers | Not described | |
| Chronic hepatitis C | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis progression rate
Measured: 20 years
The incidence of cirrhosis
Measured: 20 years
Risk factors for the occurrence of cirrhosis
Measured: 20 years
Secondary outcomes (2)
The incidence of hepatocellular carcinoma
Measured: 20 years
Number of participants with chronic hepatitis C-related complications
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing YouAn Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongping Duan, Beijing YouAn Hospital
- Investigators
- Zhongping Duan, Ph.D.,M.D., Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011932
- Sponsor's protocol ID
- BJYAH-2011-045
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.
PubMed 12407575Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
PubMed 9121257Ghany MG, Kleiner DE, Alter H, Doo E, Khokar F, Promrat K, Herion D, Park Y, Liang TJ, Hoofnagle JH. Progression of fibrosis in chronic hepatitis C. Gastroenterology. 2003 Jan;124(1):97-104. doi: 10.1053/gast.2003.50018.
PubMed 12512034Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000 Jan 18;132(2):105-11. doi: 10.7326/0003-4819-132-2-200001180-00003.
PubMed 10644270
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation
- ClinicalTrials.gov ID
- NCT02011932
- Acronym / sponsor ID
- BJYAH-2011-045
- Conditions
- Hepatitis C, Chronic, Disease Progression, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Beijing YouAn HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2030 (estimated)
- First posted
- 16 Dec 2013 (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 purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Chronic hepatitis C | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The plasma donors were primarily chosen from healthy farmers and agricultural workers living in a remote small city in the Northwest China.
Key inclusion criteria (3 listed)
- All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.
- The Hepatitis C Virus antibody was positive.
- All patients did not receive interferon therapy before being recruited.
Key exclusion criteria (2 listed)
- Patients with evidences for other forms of liver diseases.
- The coinfection with hepatitis B virus or other virus.
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
Fibrosis progression rate
Time frame: 20 years
The incidence of cirrhosis
Time frame: 20 years
Risk factors for the occurrence of cirrhosis
Time frame: 20 years
2 secondary outcomes
The incidence of hepatocellular carcinoma
Time frame: 20 years
Number of participants with chronic hepatitis C-related complications
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Background: PubMed 12407575Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.
- Background: PubMed 9121257Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
- Background: PubMed 12512034Ghany MG, Kleiner DE, Alter H, Doo E, Khokar F, Promrat K, Herion D, Park Y, Liang TJ, Hoofnagle JH. Progression of fibrosis in chronic hepatitis C. Gastroenterology. 2003 Jan;124(1):97-104. doi: 10.1053/gast.2003.50018.
- Background: PubMed 10644270Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000 Jan 18;132(2):105-11. doi: 10.7326/0003-4819-132-2-200001180-00003.
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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.
Zhongping Duan, Ph.D.,M.D. principal investigator
Beijing YouAn Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Disease Progression, run by Beijing YouAn Hospital.
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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Fibrosis progression rate (time frame: 20 years). The study lists 3 primary outcomes in all. 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 NCT02011932, which also lists 4 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 17 Dec 2013.