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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mahmoud Ab Mahmoud contact

01064344557

mam_rahman2015@yahoo.com

Asmaa Ab Abdullah contact

01141002390

Asmaaabdelazziz6@gmail.com

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.

  1. 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)
  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.

  1. First posted5 Apr 2018
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 Oct 2020 (estimated)

Resources

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)
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

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.

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