Hepatitis ENCT03488589
HEV in Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver
An observational study of Hepatitis E, run by Mahmoud Abdel Rahman.
Trial summary
Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3 million human cases per year worldwide, with around 70,000 deaths. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis E
- What is being tested?
- serum samples for HEV RNA PCR
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients fulfilling the inclusion criteria of acute hepatitis either admitted to Al-Rajhi University hospital for liver,visiting Al-Rajhy university hospital outpatient clinics for gastroentrology and hepatology or consultations from other departments at Assiut University hospitals
Who may be able to join
- • Patients have clinical diagnosis of acute viral hepatitis as (recent onset of nausea, fever, fatigue, abdominal pain , hepatomegaly and abnormal transaminases (at least 2 fold higher than the upper normal level))
- Post-transplant acute hepatitis
Who cannot join
- hepatitis A, B and C patients
- autoimmune hepatitis
- Alcoholism
- Treatment with hepatotoxic drugs
- Biliary disease
- Infection with CMV or EBV
- Taken ribavirin therapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hepatitis E Virus Infection Among Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver
Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3 million human cases per year worldwide, with around 70,000 deaths. Most cases occur in endemic countries, but the number of cases in low-endemic areas has increased. HEV seroprevalence is high in developing countries, such as India and Southeast Asia, ranging from 27-80%. Acute disease mortality is 1-4%, with risk being higher in pregnant women and immunodeficient patients.
The four more prevalent genotypes are allocated into two groups. Epidemic hepatitis E includes genotypes 1 and 2, which are considered human viruses and have caused the epidemics of hepatitis. These forms are transmitted mainly by contaminated water and the fecal-oral route. endemic hepatitis E includes genotypes 3 and 4, which are considered swine viruses (common in domestic and wild pigs), capable of infecting humans as an accidental host and therefore considered zoonotics.
Read more
The course and clinical presentation of hepatitis E is highly variable. The detailed mechanisms that lead to the different clinical outcomes in hepatitis E are only partially understood. It is known that both viral factors (genotype and dose of inoculum) and host factors (presence of previous liver disease, pregnancy and distinct genetic polymorphisms) determine the course of infection. In most cases, hepatitis E causes self-limited illness, lasting from a few days to weeks, with an average of 4-6 weeks. However, in developed countries it can cause chronic disease with rapid progression to cirrhosis, especially in patients who are transplanted, have hematological malignancies requiring chemotherapy, or have infection with HIV.
Hepatitis E is an underdiagnosed disease, partly due to the use of serological tests with low sensitivity. Diagnosis can be made indirectly by detecting antibodies against HEV in the serum, or directly by detecting the genome of the virus in blood or other body fluids. The tests for anti-hepatitis E antibody screening are commercially available, but none of them has been approved by the Food and Drug Administration (FDA). Unfortunately, the sensitivity and specificity of these tests vary greatly and this could explain the discrepancies in rates of anti-hepatitis E antibodies published for the various populations studied. The tests for viral RNA in serum and feces are confirmatory, but still experimental.
- Conditions
- Hepatitis E
- Being tested
- serum samples for HEV RNA PCR
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum samples for HEV RNA PCRDiagnostic test
serum samples HEV RNA PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
HEV incidence estimation among acute hepatitis patients
in our university hospital HEV is underestimated due to the lack of laboratory investigation of it . so, by this study we aim to estimate the number of affected cases with HEV infection among symptomatic patients with acute hepatitis.
Measured: 1-2 years
Secondary outcomes (1)
Detection of Hepatitis E viral nucleic acid in stool and serum
Detection of Hepatitis E viral nucleic acid in stool and serum of acute non- A, B or C hepatitis patients and compare between the viral load in both samples. and according the results we can recommend the preferred sample type to be used later for detection of the virus .
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis EStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Abdel Rahman
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Mahmoud Abdel Rahman, Assiut University
- Investigators
- Enas A Reda, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488589
- Sponsor's protocol ID
- Assiut2018
- Status last verified
- Jul 2018
- First submitted
- 28 Mar 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis E Virus Infection Among Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver
- ClinicalTrials.gov ID
- NCT03488589
- Acronym / sponsor ID
- Assiut2018
- Conditions
- Hepatitis E
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mahmoud Abdel RahmanUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 5 Apr 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.
Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3 million human cases per year worldwide, with around 70,000 deaths. Most cases occur in endemic countries, but the number of cases in low-endemic areas has increased. HEV seroprevalence is high in developing countries, such as India and Southeast Asia, ranging from 27-80%. Acute disease mortality is 1-4%, with risk being higher in pregnant women and immunodeficient patients.
The four more prevalent genotypes are allocated into two groups. Epidemic hepatitis E includes genotypes 1 and 2, which are considered human viruses and have caused the epidemics of hepatitis. These forms are transmitted mainly by contaminated water and the fecal-oral route. endemic hepatitis E includes genotypes 3 and 4, which are considered swine viruses (common in domestic and wild pigs), capable of infecting humans as an accidental host and therefore considered zoonotics.
The course and clinical presentation of hepatitis E is highly variable. The detailed mechanisms that lead to the different clinical outcomes in hepatitis E are only partially understood. It is known that both viral factors (genotype and dose of inoculum) and host factors (presence of previous liver disease, pregnancy and distinct genetic polymorphisms) determine the course of infection. In most cases, hepatitis E causes self-limited illness, lasting from a few days to weeks, with an average of 4-6 weeks. However, in developed countries it can cause chronic disease with rapid progression to cirrhosis, especially in patients who are transplanted, have hematological malignancies requiring chemotherapy, or have infection with HIV.
Hepatitis E is an underdiagnosed disease, partly due to the use of serological tests with low sensitivity. Diagnosis can be made indirectly by detecting antibodies against HEV in the serum, or directly by detecting the genome of the virus in blood or other body fluids. The tests for anti-hepatitis E antibody screening are commercially available, but none of them has been approved by the Food and Drug Administration (FDA). Unfortunately, the sensitivity and specificity of these tests vary greatly and this could explain the discrepancies in rates of anti-hepatitis E antibodies published for the various populations studied. The tests for viral RNA in serum and feces are confirmatory, but still experimental.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients fulfilling the inclusion criteria of acute hepatitis either admitted to Al-Rajhi University hospital for liver,visiting Al-Rajhy university hospital outpatient clinics for gastroentrology and hepatology or consultations from other departments at Assiut University hospitals
Key inclusion criteria (2 listed)
- • Patients have clinical diagnosis of acute viral hepatitis as (recent onset of nausea, fever, fatigue, abdominal pain , hepatomegaly and abnormal transaminases (at least 2 fold higher than the upper normal level))
Key exclusion criteria (7 listed)
- hepatitis A, B and C patients
- autoimmune hepatitis
- Alcoholism
- Treatment with hepatotoxic drugs
- Biliary 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 |
|---|---|---|
| serum samples for HEV RNA PCRserum samples HEV RNA PCR | Diagnostic test | – |
Primary outcome
HEV incidence estimation among acute hepatitis patients
Time frame: 1-2 years
in our university hospital HEV is underestimated due to the lack of laboratory investigation of it . so, by this study we aim to estimate the number of affected cases with HEV infection among symptomatic patients with acute hepatitis.
1 secondary outcome
Detection of Hepatitis E viral nucleic acid in stool and serum
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: Yes
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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.
Enas A Reda, professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis E, run by Mahmoud Abdel Rahman.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud Ab Mahmoud (01064344557, mam_rahman2015@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEV incidence estimation among acute hepatitis patients (time frame: 1-2 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 24 Jul 2018.