Chronic Hepatitis CNCT01453244
Pharmacogenomic Research in Korean Patients With Hepatitis C
An observational study of Chronic Hepatitis C, run by Inje University at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 373 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Mar 2013
- 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: Korean patients with chronic hepatitis C
Who may be able to join
- Hepatitis C virus infected patients
Who cannot join
- Patients who infected Hepatitis B virus or Human immunodeficiency virus
- HCV infected patients previously treated with antiviral drugs
- Patients had a history of autoimmune hemolytic anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C
The aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Pharmacogenomics, IL28B, ITPA
- Medical subject headings
- Hepatitis C, 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 |
|---|---|---|
| SVR group | A patients who achieved SVR (sustained virologic response) | |
| non-SVR group | A patients who not achieved SVR (sustained virologic response) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (SVR)
Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment
Measured: 24 weeks after the end of treatment
Secondary outcomes (1)
Anemia
- a reduction in Hemoglobin of >3.0 g/dL
- a reduction in Hemoglobin levels to 10.0g/dL.
Measured: 4 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- Jae-Gook Shin, M.D, phD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453244
- Sponsor's protocol ID
- 11-037
- Status last verified
- May 2013
- First submitted
- 13 Oct 2011
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C
- ClinicalTrials.gov ID
- NCT01453244
- Acronym / sponsor ID
- 11-037
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Pharmacogenomics, IL28B, ITPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Oct 2011 (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 aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVR group | – | –A patients who achieved SVR (sustained virologic response) |
| non-SVR group | – | –A patients who not achieved SVR (sustained virologic response) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean patients with chronic hepatitis C
Key inclusion criteria (1 listed)
- Hepatitis C virus infected patients
Key exclusion criteria (3 listed)
- Patients who infected Hepatitis B virus or Human immunodeficiency virus
- HCV infected patients previously treated with antiviral drugs
- Patients had a history of autoimmune hemolytic anemia
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
Sustained virological response (SVR)
Time frame: 24 weeks after the end of treatment
Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment
1 secondary outcome
Anemia
Time frame: 4 weeks after start of treatment
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 3 Jun 2013.
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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.
Jae-Gook Shin, M.D, phD principal investigator
Inje 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 Chronic Hepatitis C, run by Inje University at 1 site in South Korea.
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 3 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 3 Jun 2013. 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 South Korea. 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?
Sustained virological response (SVR) (time frame: 24 weeks after the end of treatment). 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 3 Jun 2013.