Hemodialysed Patients With Impaired Liver EnzymesNCT01054664
The Incidence of Occult Hepatitis C Virus Infection in Hemodialysed Patients With Liver Enzymes Disturbances
An observational study of Hemodialysed Patients With Impaired Liver Enzymes, run by Meir Medical Center at 1 site in Israel.
Trial summary
To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild impairment of liver enzymes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysed Patients With Impaired Liver Enzymes
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to not given
- 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: hemodialysis patients with impaired liver enzymes
Who may be able to join
- Hemodialysed patients with impaired liver enzymes
Who cannot join
- hepatitis B and C positive
Trial locations and contacts
1 site in 1 country.
Israel1 site
Plotkin Eleonora
Kfar Saba
Osnat Klein, MD, 972 9 7472517, Klein.Osnat@clalit.org.il
About this study
To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild impairment of liver enzymes
Read the detailed description
occult hepatitis C virus will be checked in monocytes of hemodialyzed patients with permanent mild impairment of liver enzymes This population has no evidence of hepatitis B or C according to standard laboratory tests (HVC antibodies,HCV PCR, hepatitis B antibodies) Hepatitis C virus RNA will be performed in peripheral blood mononuclear cells of hemodialysed patients
- Keywords
- liver enzymes, peripheral mononuclear blood cells, hemodialysis, hepatitis C, RNA
- 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 |
|---|---|---|
| impaired liver enzymes | Not described | |
| normal liver enzymes | Not described | |
| hepatitis C antibodies positive | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysed Patients With Impaired Liver EnzymesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054664
- Sponsor's protocol ID
- nephrop003
- Status last verified
- Jan 2010
- First submitted
- 21 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Occult Hepatitis C Virus Infection in Hemodialysed Patients With Liver Enzymes Disturbances
- ClinicalTrials.gov ID
- NCT01054664
- Acronym / sponsor ID
- nephrop003
- Keywords
- liver enzymes, peripheral mononuclear blood cells, hemodialysis, hepatitis C, RNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- First posted
- 22 Jan 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.
To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild impairment of liver enzymes
Detailed description
occult hepatitis C virus will be checked in monocytes of hemodialyzed patients with permanent mild impairment of liver enzymes This population has no evidence of hepatitis B or C according to standard laboratory tests (HVC antibodies,HCV PCR, hepatitis B antibodies) Hepatitis C virus RNA will be performed in peripheral blood mononuclear cells of hemodialysed patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| impaired liver enzymes | – | – |
| normal liver enzymes | – | – |
| hepatitis C antibodies positive | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis patients with impaired liver enzymes
Key inclusion criteria (1 listed)
- Hemodialysed patients with impaired liver enzymes
Key exclusion criteria (1 listed)
- hepatitis B and C positive
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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.
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 Hemodialysed Patients With Impaired Liver Enzymes, run by Meir Medical Center 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 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 22 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Plotkin, MD (972 9 7472517, nora.plotkin@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Jan 2010.