Chronic Hepatitis C Viral InfectionNCT01159613
Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
An observational study of Chronic Hepatitis C Viral Infection, run by Ziv Hospital at 1 site in Israel.
Trial summary
The working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Viral Infection
- What is being tested?
- Responders and Non Responders
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Jan 2009
- 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: chronic HCV genotype 1 naïve patients
Who may be able to join
- Chronic HCV genotype 1 naive patients
Who cannot join
- Co infection with HBV, HIV, HDV
- Decompensated liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Low HDL Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
The working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.
Read the detailed description
Lipoproteins are closely connected to the process of hepatitis C virus (HCV) infection. Metabolic syndrome predicts negative treatment outcome in HCV infection.
Aim: to assess the association between lipids components of the metabolic syndrome and sustained viral response (SVR).
- Conditions
- Chronic Hepatitis C Viral Infection
- Being tested
- Responders, Non Responders
- Keywords
- SVR, Cholesterol level, fibrosis score, HDL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespondersOther
Responders
Non RespondersOther
Non Responders
| Study group | Role | What they receive |
|---|---|---|
| Non Responders | Non Responders Receives: Other: Non Responders | |
| RESPONDERS | Not described Receives: Other: Responders |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained viral response
achieving SVR
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Viral InfectionStudies 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
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Collaborators
- Hillel Yafe MC Hadera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159613
- Sponsor's protocol ID
- HDL + HCV
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 9 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Low HDL Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
- ClinicalTrials.gov ID
- NCT01159613
- Acronym / sponsor ID
- HDL + HCV
- Conditions
- Chronic Hepatitis C Viral Infection
- Keywords
- SVR, Cholesterol level, fibrosis score, HDL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ziv HospitalOther government
- Collaborators
- Hillel Yafe MC Hadera
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Jul 2010 (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 working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.
Detailed description
Lipoproteins are closely connected to the process of hepatitis C virus (HCV) infection. Metabolic syndrome predicts negative treatment outcome in HCV infection.
Aim: to assess the association between lipids components of the metabolic syndrome and sustained viral response (SVR).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Responders | – | Other: Non RespondersNon Responders |
| RESPONDERS | – | Other: Responders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic HCV genotype 1 naïve patients
Key inclusion criteria (1 listed)
- Chronic HCV genotype 1 naive patients
Key exclusion criteria (2 listed)
- Co infection with HBV, HIV, HDV
- Decompensated liver disease
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 |
|---|---|---|
| RespondersResponders | Other | RESPONDERS |
| Non RespondersNon Responders | Other | Non Responders |
Primary outcome
sustained viral response
Time frame: 72 weeks
achieving SVR
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 9 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Viral Infection, run by Ziv Hospital at 1 site in Israel.
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 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: finished, as of the sponsor's last update on 9 Jul 2010. 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 Israel. 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 viral response (time frame: 72 weeks). 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 9 Jul 2010.