Hepatitis CNCT03587714
Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients
An observational study of Hepatitis C, run by Assiut University at 1 site in Egypt.
Trial summary
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- HCV RT-PCR
- How many people
- 800 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Mar 2018
- How long will I take part?
- 3 Months
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All rheumatologic and other muscloskeletal diseased patients attending Rheumatology clinic Assuit university hospital
Who may be able to join
- Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection
Who cannot join
- pregnancy and end organ failure
Trial locations and contacts
1 site in 1 country.
About this study
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.
Read the detailed description
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.
This study aims at detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt.
Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection. Patients' serum samples were screened for the presence of anti-HCV antibodies. Patients with positive serology were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)
- Conditions
- Hepatitis C
- Being tested
- HCV RT-PCR
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV RT-PCRDiagnostic test
HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RT-PCR
positive
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Jan 2017
- Primary completion1 Dec 2017
- Study completion1 Mar 2018
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 Assiut UniversityThe 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
- Cross-sectional
- Enrolment
- 800 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Manal Hassanien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587714
- Sponsor's protocol ID
- Hepatitis C
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients
- ClinicalTrials.gov ID
- NCT03587714
- Acronym / sponsor ID
- Hepatitis C
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 16 Jul 2018 (actual)
- 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.
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.
Detailed description
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.
This study aims at detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt.
Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection. Patients' serum samples were screened for the presence of anti-HCV antibodies. Patients with positive serology were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All rheumatologic and other muscloskeletal diseased patients attending Rheumatology clinic Assuit university hospital
Key inclusion criteria (1 listed)
- Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection
Key exclusion criteria (1 listed)
- pregnancy and end organ failure
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 |
|---|---|---|
| HCV RT-PCRHCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR) | Diagnostic test | – |
Primary outcome
HCV RT-PCR
Time frame: 3 months
positive
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 16 Jul 2018.
- Individual participant dataSharing planned: Yes. detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt
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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.
Manal Hassanien, MD principal investigator
Assiut 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 Hepatitis C, run by Assiut University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 16 Jul 2018. 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 Egypt. 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?
HCV RT-PCR (time frame: 3 months). 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 16 Jul 2018.