An interventional study of Reiferon R and Ribavirin in Hepatitis C, Chronic, sponsored by National Liver Institute, Egypt. Completed at 3 sites in Egypt. Open to participants aged 3 Years to 19 Years. Per ClinicalTrials.gov, last updated 2014-01-06.
Sponsored by National Liver Institute, Egypt · Not applicable, Interventional, and Treatment
Egypt has the highest prevalence of hepatitis C virus infection in adults (up to 20%) and children (up to 5.5%). The major genotype (90%) is type 4. Pegylated interferon-alpha-2a or -2b and ribavirin have been used in small numbers of hepatitis C virus-infected children with sustained virological response being higher in genotypes 2 and 3 than in genotypes 1 and 4. Genotype 4 is has been described as difficult-to-treat genotype. Several attempts to modify treatment protocols have been tried in adults in an attempt to achieve higher rates of sustained virological response. Shortening injection interval and/or treatment duration prolongation have been tried with variable outcome reports.
A novel Hansenula- derived pegylated interferon alpha 2a: 20 Kilo dalton (Reiferon Retard) has been used over the last 4 years in the Egyptian market.
We aimed to investigate the safety and efficacy of Reiferon retard plus ribavirin customized regimen in hepatitis C virus-RNA seropositive Egyptian children. Forty six children with chronic hepatitis C virus aged 3-19 years were selected from 3 hepatic tertiary centers.
Clinical and laboratory evaluation were undertaken. Quantitative polymerase chain reaction (PCR) for HCV-RNA was done before starting treatment, at 4, 12, 24, 48, 72 weeks during treatment and 6 months after stoppage of treatment. All patients were assigned to receive a weekly subcutaneous injection of pegylated interferon alpha 2-a ( Reiferon Retard) plus oral Ribavirin daily for 12 weeks ,then cases were divided according to PCR results into 2 groups.
Group I: Patients who continued treatment on weekly basis: this group included patients who had negative PCR at week 12 as well those who had positive PCR without any change in viremia. Group II: Patients who continued treatment on a 5- days schedule: this group included patients who had any decrease in viremia at week 12.
Patients who were PCR-negative at week 48 and had at least one PCR-positive test during therapy were assigned to have an extended treatment course of 6 months duration.
The occurrence of adverse effects was assessed during treatment and follow up
hepatitis C virus is a major health problem, not only in adults but also in the pediatric age group. In Egypt, the prevalent genotype is the difficult-to-treat genotype 4. Attempts are being made to improve the treatment outcomes. In the current study we aim to investigate the effect of customized pegylated interferon-alpha-2a plus ribavirin in children with chronic hepatitis C virus. For that, 46 children with chronic hepatitis C virus were recruited from three tertiary Pediatric Hepatology centers. All were assigned to receive weekly subcutaneous pegylated interferon-alpha-2a plus daily ribavirin for 12 weeks. At this point, the study population was divided into two arms. Arm 1 included those who became hepatitis C virus-RNA negative by polymerase chain reaction and those who showed no change of viremia or a decrease of less than 1 log. This group continued treatment on weekly bases for 48 weeks, even those who are hepatitis C virus-RNA positive. Arm 2; included patients who had a decrease in viremia more than one log of pre-treatment viremia level. For those patients, injection interval was shortened to every 5-day for a completion period of 48 weeks. Patients from either group who were polymerase chain reaction-negative at week 48, but had at least one polymerase chain reaction-positive test during therapy, were assigned to have an extended treatment course up to 72 weeks.
So the first customization was,
The occurrence of adverse effects, virological and biochemical responses were assessed during treatment and follow up.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 46 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →National Liver Institute, Egypt is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
patients who continued treatment on weekly basis (7-day schedule). This group included patients who were HCV-RNA negative at week 12 and those who had \< 1 log decrease in HCV-RNA viremia
Drug: Reiferon R · Drug: Ribavirin
patients who continued treatment on a 5-day schedule. This group included patients who had ≥ 1 log decrease in viremia (compared to pre-treatment level) at week 12
Drug: Reiferon R · Drug: Ribavirin
subcutaneous injection of 100 μg/m2
Also known as: Hansenula-derived pegylated interferon alpha 2a, Reiferon Retard
15 mg/kg daily on two divided doses
To study the safety of Hansenula-Derived Pegylated-Interferon Alpha-2a (Reiferon retard) in attaining sustained virological response in children with chronic hepatitis C virus infection
The efficacy and Safety was assessed during the 48 weeks of therapy, patients were monitored clinically, laboratory for the appearance of any side effects
Time frame: 48 weeks
Efficacy of treatment customization on the outcome
To assess the effect of tailoring treatment \[by decreasing the interval between injection (5days vs 7 days) and prolonging duration of therapy (48 weeks vs 72 weeks)\] on sustained virological response based on the on-treatment virologic response
Time frame: 96 weeks
To assess predictors of sustained virological response
1. compare demographic parameters in responders and non-responders 2. comparing pretreatment hepatitis C viremia in responders and non-responders 3. compare expected duration of infection in responders and non-responders 4. compare histopathological changes in responders and non-responders 5. compare pretreatment liver enzymes in responders and non-responders 6. compare treatment duration in responders and non-responders 7. compare injection interval in responders and non-responders
Time frame: 96 weeks
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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National Liver Institute, Egypt