|
Transfusion Associated HCV in a Pediatric Population Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Transfusion Associated HCV in a Pediatric Population conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Transfusion Associated HCV in a Pediatric Population Clinical research trials and Transfusion Associated HCV in a Pediatric Population healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Transfusion Associated HCV in a Pediatric Population. Transfusion Associated HCV in a Pediatric Population Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Transfusion Associated HCV in a Pediatric Population clinical trial. Human subjects often receive the most effective healthcare possible for their Transfusion Associated HCV in a Pediatric Population condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Transfusion Associated HCV in a Pediatric Population  Transfusion Associated HCV in a Pediatric Population
Transfusion Associated HCV in a Pediatric Population
For Condition: Blood Transfusion,Hepatitis, Viral, Human
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To identify a large cohort of children transfused in the decade prior to second-generation anti-hepatitis C virus (HCV) donor screening (1982-1992). This will not only identify cases for the study of persistent infection and chronic hepatitis in children, but will allow for the determination of the annualized risk of transfusion-associated hepatitis (TAH) infection in children, data that are not currently available.
Details: BACKGROUND: Accumulating data indicate that 70 to 80 percent of adults infected with the hepatitis C virus (HCV) develop persistent infection that may be associated with chronic hepatitis, cirrhosis, hepatocellular carcinoma and end-stage liver disease. Despite these potential mortal outcomes, the progression is indolent, and serious chronic sequelae may not occur for 10 to 50 years, by which time many transfused adults have died of unrelated causes. Infants and children, on the other hand, are far more likely to survive their transfusion episode, to have a long life span after HCV acquisition and, by inference, to experience the decades-long evolution to HCV-related cirrhosis and hepatocellular carcinoma. DESIGN NARRATIVE: The years 1982-1992 have been selected because TAH incidence in adults was still high at that time and because all subjects would be under age 15 at enrollment and unlikely to have been exposed to sexual contact or IV drug use. Maternal testing is performed to exclude perinatal transmission. Sixty-five hundred children who meet the eligibility criteria of the study have been transfused at Children's National Medical Center (CNMC) during this period, and archival serum specimens are available for 22 percent. The total eligible cohort is contacted and asked to provide a blood sample that is tested for antibodies to HCV and to the newly discovered hepatitis G virus (HGV). Subjects found antibody positive on initial screen are enrolled in long-term followup that includes serial determinations for alanine aminotransferase (ALT), other liver-related assays, viral serology with confirmatory testing, PCR for HCV and HGV RNA, HCV genotyping and, in those with evidence of chronic hepatitis, liver biopsy. Biopsy may also be performed on a subset with chronic viremia, but normal ALT, pending approval of an advisory panel of liver experts. A serum repository will be established for evaluation of new diagnostic methods for HCV, HGV, and other etiologic agents of posttranstusion hepatitis. This study will determine the minimal rate of transfusion-induced HCV and HGV infection and will allow for an annualized incidence estimate and a determination of the national burden of transfusion-induced hepatitis virus infection in children, a value that is currently unknown. In addition, by use of archival samples and the interval from transfusion to testing, the study will determine the duration of infection and rate of viral persistence. Finally, prospective followup with liver biopsy will establish the extent of disease in those chronically infected. If persistent infection and chronic liver disease are as common in children as in adults, this would have major implications for anti-viral therapy programs and might shift treatment emphasis to pediatric populations where response rates might be higher and where long-term benefit would be greater.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 4319;
Study Start Date: May 1996
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005402
Other Blood Transfusion Studies:
1. Risk of Post Transfusion Hepatitis C Virus Infection
2. Prospective Study of HIV Infection in Hemophiliacs
3. Trial to Reduce Alloimmunization to Platelets (TRAP)
4. KSHV Infection in Blood Donors from Texas
5. Retrovirus Epidemiology Donor Study I (REDS I)
Related Studies:
Other Blood Transfusion Clinical Trials
Other Clinical Trials
Other Clinical Trials
Transfusion Associated HCV in a Pediatric Population
|
|
|
|
|
|
|
|
