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Parvovirus B19 Infection in Hereditary Hemolytic Anemias Patients

Egypt244 participantsStarted 2018-02-10

Plain-language summary

Although many studies investigated the prevalence and manifestations of HPV-B19 infection in patients with sickle cell anemia (SCA), thalassemia, and hereditary spherocytosis (HS) separately, there is limited information about the extent to which HPV-B19 infection leads to severe complications and chronic infection.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed hereditary hemolytic anemias patients (age above 12 years) presented with signs and symptoms of hereditary hemolytic anemia (HHA) and admitted or treated in emergency departments or Hematology Units at Internal Medicine Departments of various university hospitals will be screened for enrollment in this study. Exclusion Criteria: * • Patients will be diagnosed with non-HHA as ( autoimmune hemolytic anemia, microangiopathic hemolytic anemia (MAHA), Wilson disease, paroxysmal nocturnal hemoglobinuria (PNH). * HHA-patients will refuse to consent to this study. * Serologic evidence of recent virus infection other than human parvovirus B19 (HPV-B19); hepatitis A (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E virus (HEV,) cytomegalovirus (CMV), Epstein-Barr virus (EBV), or positive test for HIV. * HHA patients with uncontrolled diabetes mellitus (DM). * HHA patients with a history of nephrotic syndrome or chronic kidney disease(CKD). * HHA patients with a history of treatment by immunosuppressive drugs. * HHA patients with clinical and laboratory evidence of relevant toxicity related to iron chelation. * HHA patients with severe systemic diseases (such as cardiovascular, renal, and hepatic disease) or surgical/medical conditions that might interfere with follow-up instructions. * HHA patients with a life expectancy of less than 1 year. * HHA patients with psychiatric disorders or a history of drug abuse, *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of hereditary hemolytic anemias (HHA) patients with symptomatic HPV-B19 infection

Timeframe: 2 years

Common clinical manifestations of symptomatic HPV-B19 infection in patients with HHA

Timeframe: 2 years

Number of cytopenias

Timeframe: 2 years

Number of patients presenting with extreme hyperbilirubinemia during HPV-B19 infection

Timeframe: 2 years

Frequency of autoimmune bone marrow failure

Timeframe: 2 years

Frequency of autoimmune hepatitis

Timeframe: Through study completion

Frequency of renal involvement and acute kidney injury

Timeframe: Through study completion

Trial details

NCT IDNCT04822090

SponsorSohag University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-10

View on ClinicalTrials.gov More Parvovirus B19 Infection trials

Plain-language summary

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of hereditary hemolytic anemias (HHA) patients with symptomatic HPV-B19 infection

Timeframe: 2 years

Common clinical manifestations of symptomatic HPV-B19 infection in patients with HHA

Timeframe: 2 years

Number of cytopenias

Timeframe: 2 years

Number of patients presenting with extreme hyperbilirubinemia during HPV-B19 infection

Timeframe: 2 years

Frequency of autoimmune bone marrow failure

Timeframe: 2 years

Frequency of autoimmune hepatitis

Timeframe: Through study completion

Frequency of renal involvement and acute kidney injury

Timeframe: Through study completion