Hepatitis CNCT01025531
Cell Bound Complement Activation Proteins as Markers of Liver Injury
An observational study of Hepatitis C, run by University of Pittsburgh at 1 site in United States.
Trial summary
Subjects who eventually undergo treatment for HCV, we will gather treatment data (start and stop dates), and repeat CB-CAP analysis at weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2014
- 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: patients who are newly diagnosed with Hepatitis C
Who may be able to join
- Age 18 years of age or older at time of evaluation
- Able to give informed consent
- Confirmed HCV infection by standard antibody testing any time prior to enrollment
- Detectable HCV RNA in routine clinical testing any time prior to enrolment (since our aim is to determine the correlation between CB-CAPs and histologic activity in chronic HCV)
- Undergoing liver biopsy as part of their routine clinical care
Who cannot join
- Any previous treatment for HCV
- Any other chronic or active liver disease that, in the opinion of the investigator, can affect liver histology (history of alcohol use in itself will not be an exclusion criteria)
- HIV coinfection
- Chronic Hepatitis B infection (HBsAg+ or HBeAg+ or HBV DNA+ upon last testing)
- Acute Hepatitis A infection (HAV IgM+ upon last testing)
- Use of medications that may cause increase in serum aminotransferase levels (e.g. HMG co-A reductase inhibitors, anti-epileptics, etc.) within 30 days prior to enrollment
- Any chronic or active inflammatory disease that may potentially be associated with higher inflammatory markers (examples include, but not limited to: tuberculosis, inflammatory bowel disease, pneumonia, autoimmune disease)
Trial locations and contacts
1 site in 1 country.
About this study
Subjects who eventually undergo treatment for HCV, we will gather treatment data (start and stop dates), and repeat CB-CAP analysis at weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Routine laboratory data will also be collected at these time points.
Read the detailed description
The investigators will recruit consecutive HCV infected subjects from the Center for Liver Diseases (CLD) at the University of Pittsburgh Medical Center (UPMC) who are scheduled to undergo a liver biopsy as part of their routine clinical care. The liver biopsies will be read concurrently by a single study pathologist who is blinded to the subjects' clinical status. At the time of liver biopsy, blood will be drawn to perform CB-CAP assays. The CB-CAP levels will be correlated with the liver biopsy result to assess their ability to predict degree of liver injury. The investigators will retrieve labs done for routine clinical care closest to the time of liver biopsy, including complete blood count, serum aminotransferase levels, and a biochemical profile.
A total of 250 subjects will be recruited for this study. Data gathered would include demographic and clinical information, risk factors for HCV, information about drug and alcohol use and anthropometric measurements (height, weight, abdominal circumference, etc.).
For the subset of subjects who are then initiated on treatment for HCV by their healthcare providers, we will gather treatment information (start date, stop date, treatment regimen and dosage, etc.) and blood will be drawn at treatment weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Routine laboratory data will also be collected at these time points. The +/- 2 week time window is allowed so that the blood draw can be done at a routine clinical visit.
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- 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 |
|---|---|---|
| patients with newly diagnosed Hepatitis C | Hepatitis C patients newly diagnosed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the association between CB-CAP levels and liver fibrosis
Measured: 5 years
Secondary outcomes (1)
Determine the effect of HCV treatment upon CB-CAP levels
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 posted3 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeel Butt, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025531
- Sponsor's protocol ID
- PRO08060224
- Other IDs
- physician funding
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2009
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Bound Complement Activation Proteins as Markers of Liver Injury
- ClinicalTrials.gov ID
- NCT01025531
- Acronym / sponsor ID
- PRO08060224
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Dec 2009 (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.
Subjects who eventually undergo treatment for HCV, we will gather treatment data (start and stop dates), and repeat CB-CAP analysis at weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Routine laboratory data will also be collected at these time points.
Detailed description
The investigators will recruit consecutive HCV infected subjects from the Center for Liver Diseases (CLD) at the University of Pittsburgh Medical Center (UPMC) who are scheduled to undergo a liver biopsy as part of their routine clinical care. The liver biopsies will be read concurrently by a single study pathologist who is blinded to the subjects' clinical status. At the time of liver biopsy, blood will be drawn to perform CB-CAP assays. The CB-CAP levels will be correlated with the liver biopsy result to assess their ability to predict degree of liver injury. The investigators will retrieve labs done for routine clinical care closest to the time of liver biopsy, including complete blood count, serum aminotransferase levels, and a biochemical profile.
A total of 250 subjects will be recruited for this study. Data gathered would include demographic and clinical information, risk factors for HCV, information about drug and alcohol use and anthropometric measurements (height, weight, abdominal circumference, etc.).
For the subset of subjects who are then initiated on treatment for HCV by their healthcare providers, we will gather treatment information (start date, stop date, treatment regimen and dosage, etc.) and blood will be drawn at treatment weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Routine laboratory data will also be collected at these time points. The +/- 2 week time window is allowed so that the blood draw can be done at a routine clinical visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with newly diagnosed Hepatitis C | – | –Hepatitis C patients newly diagnosed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are newly diagnosed with Hepatitis C
Key inclusion criteria (5 listed)
- Age 18 years of age or older at time of evaluation
- Able to give informed consent
- Confirmed HCV infection by standard antibody testing any time prior to enrollment
- Detectable HCV RNA in routine clinical testing any time prior to enrolment (since our aim is to determine the correlation between CB-CAPs and histologic activity in chronic HCV)
- Undergoing liver biopsy as part of their routine clinical care
Key exclusion criteria (7 listed)
- Any previous treatment for HCV
- Any other chronic or active liver disease that, in the opinion of the investigator, can affect liver histology (history of alcohol use in itself will not be an exclusion criteria)
- HIV coinfection
- Chronic Hepatitis B infection (HBsAg+ or HBeAg+ or HBV DNA+ upon last testing)
- Acute Hepatitis A infection (HAV IgM+ upon last testing)
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
Determine the association between CB-CAP levels and liver fibrosis
Time frame: 5 years
1 secondary outcome
Determine the effect of HCV treatment upon CB-CAP levels
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Adeel Butt, MD principal investigator
University of Pittsburgh
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 University of Pittsburgh at 1 site in United States.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 8 Dec 2014. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the association between CB-CAP levels and liver fibrosis (time frame: 5 years). 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 8 Dec 2014.