Hepatitis C PatientsNCT01195987
Immune Dysregulation in Hepatitis C Patients With or Without Arthritis
An observational study of Hepatitis C Patients, run by The Center for Rheumatic Disease, Allergy, & Immunology at 1 site in United States.
Trial summary
The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Patients
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hepatitis positive patients with and without osteoarthritis, with a group of Hepatitis C negative and no osteoarthritis to serve as controls.
Who may be able to join
- All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment.
- Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment.
- 10 normal healthy controls- Hep C neg and without osteoarthritis (OA).
Who cannot join
- HIV patients
- Those with concomitant alcoholic liver disease
- Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
Nabih I Abdou, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Center for Rheumatic Disease, Allergy & Immunology
Kansas City, Missouri, 64111
Cindy A Greenwell, MD, PHD, 816-531-0930, cindy@centerforrheumatic.com
Nabih I Abdou, MD, PhD
About this study
The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.
Read the detailed description
Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.
- Conditions
- Hepatitis C Patients
- Keywords
- Hepatitis C, Arthritis
- Medical subject headings
- Hepatitis C, Arthritis
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 |
|---|---|---|
| Hepatitis C with Arthritis | Not described | |
| Hepatitis C without Arthritis | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C PatientsStudies 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
- The Center for Rheumatic Disease, Allergy, & Immunology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's Hospital
- Investigators
- Nabih I Abdou, MD, PhD, Principal investigator, Center for Rheumatic Disease, Allergy & Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195987
- Sponsor's protocol ID
- 09-290
- Status last verified
- Sep 2010
- First submitted
- 3 Sep 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Dysregulation in Hepatitis C Patients With or Without Arthritis
- ClinicalTrials.gov ID
- NCT01195987
- Acronym / sponsor ID
- 09-290
- Conditions
- Hepatitis C Patients
- Keywords
- Hepatitis C, Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & ImmunologyUniversity, hospital or other
- Collaborators
- St. Luke's Hospital
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 8 Sep 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 purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.
Detailed description
Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C with Arthritis | – | – |
| Hepatitis C without Arthritis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis positive patients with and without osteoarthritis, with a group of Hepatitis C negative and no osteoarthritis to serve as controls.
Key inclusion criteria (3 listed)
- All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment.
- Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment.
- 10 normal healthy controls- Hep C neg and without osteoarthritis (OA).
Key exclusion criteria (3 listed)
- HIV patients
- Those with concomitant alcoholic liver disease
- Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.
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 8 Sep 2010.
Related trials for Hepatitis C Patients
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Recruiting
Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum
Hepatitis C
Active, not recruitingPhase 1
DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection
Chronic Hepatitis, Hepatitis C Infection
Not yet recruitingPhase 2/3
Treatment of CKD Patients With HCV
HCV Infection ( Genotype 4) in CKD Patients
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.
Nabih I Abdou, MD, PhD contact
Nabih I Abdou, MD, PhD principal investigator
Center for Rheumatic Disease, Allergy & Immunology
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 Patients, run by The Center for Rheumatic Disease, Allergy, & Immunology 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 3 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: status not confirmed, as of the sponsor's last update on 8 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nabih I Abdou, MD, PhD (816-531-0930), 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 8 Sep 2010.