Hansenula-Derived Pegylated-Interferon Alpha-2a in Egyptian Children With Chronic HCV

NCT02027493 | Completed DMC

• 1 other identifier: NLI-YAGCC-CUPH-HCV-PEG-PED
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatitis C, Chronic

Keywords

Children; Chronic hepatitis C; Hansenula polymorpha; Pegylated interferon; Response rate; Ribavirin; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  48 weeks

Secondary Outcomes (1)

• Efficacy of treatment customization on the outcome

  96 weeks

Other Outcomes (1)

• To assess predictors of sustained virological response

  96 weeks

Study Arms (2)

Reiferon R weekly plus ribavirin

ACTIVE COMPARATOR

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

Reiferon R (every 5-day) plus ribavirin

ACTIVE COMPARATOR

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

Interventions

Reiferon R DRUG

subcutaneous injection of 100 μg/m2

Also known as: Hansenula-derived pegylated interferon alpha 2a, Reiferon Retard

Reiferon R (every 5-day) plus ribavirin; Reiferon R weekly plus ribavirin

Ribavirin DRUG

15 mg/kg daily on two divided doses

Reiferon R (every 5-day) plus ribavirin; Reiferon R weekly plus ribavirin

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children aged 3-19 years
• compensated chronic HCV infection (HCV-RNA positive by PCR for more than 6 months)
• whose hemoglobin was ≥10 g/dL
• neutrophilic count \> 1500/mm3
• platelet count \> 75,000/mm3
• normal random blood sugar
• normal serum creatinine
• normal serum ferritin
• normal thyroid function tests
• normal lipid profile
• no other causes of liver disease (autoimmune hepatitis, Wilson disease, alpha one antitrypsin deficiency nor hepatitis B virus infection).
• Liver biopsy was mandatory for enrollment

You may not qualify if:

• decompensated cirrhosis
• any other cause of liver disease associating HCV infection
• body mass index ≥ 95 percentile
• severe psychiatric conditions
• uncontrolled seizure disorder
• decompensated cardiovascular disease, renal insufficiency
• evidence of retinopathy
• decompensated thyroid disease
• hemoglobinopathy
• immunologically mediated diseases or any other chronic illness requiring long term immunosuppressive drugs
• previous interferon therapy within one year of enrollment

Sponsors & Collaborators

• National Liver Institute, Egypt: lead
• Yassin Abdelghaffar Charity Center for Liver Disease and Research: collaborator
• National Hepatology & Tropical Medicine Research Institute: collaborator
• Ain Shams University: collaborator
• Cairo University: collaborator

Study Sites (3)

Department of Pediatrics, Cairo University Pediatric Hospital

Cairo, Cairo Governorate, Egypt

Location

National Liver Institute

Menoufiya, Menofiya, 32511, Egypt

Location

Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Cairo, 2851, Egypt

Location

Related Publications (1)

• El Naghi S, Abdel-Ghaffar TY, El-Karaksy H, Abdel-Aty EF, El-Raziky MS, Allam AA, Helmy H, El-Araby HA, Behairy BE, El-Guindi MA, El-Sebaie H, Abdel-Ghaffar AY, Ehsan NA, El-Hennawy AM, Sira MM. Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children. World J Gastroenterol. 2014 Apr 28;20(16):4681-91. doi: 10.3748/wjg.v20.i16.4681.

  PMID: 24782620 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mostafa M Sira, M.D.

  Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY DIRECTOR

• Tawhida Y Abdel-Ghaffar, M.D.

  Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, 2851 Cairo, Egypt

  PRINCIPAL INVESTIGATOR

• Suzan El Naghi, M.D.

  Pediatric Department, National Hepatology and Tropical Medicine Research Institute, 11441 Cairo, Egypt

  STUDY DIRECTOR

• Hanaa El-Karaksy, M.D.

  Cairo University

  STUDY CHAIR

• Heba Helmy, M.D.

  Cairo University

  STUDY CHAIR

• Mona S El-Raziky, M.D.

  Cairo University

  STUDY CHAIR

• Elham F Abdel-Aty, M.Sc.

  Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY CHAIR

• Aleef A Allam, M.D.

  Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY CHAIR

• Hanaa A El-Araby, M.D.

  Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY CHAIR

• Behairy E Behairy, M.D.

  Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY CHAIR

• Mohamed A El Guindi, M.D.; Ph.D.

  Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY CHAIR

• Hatem El-Sebaie, M.D.

  Biochemistry Department, National Liver Institute, 32511 Menofiya, Egypt

  STUDY CHAIR

• Aisha Y Abdel-Ghaffar, M.D.

  Clinical Pathology Department, Ain Shams University, Cairo, Egypt

  STUDY CHAIR

• Nermin A Ehsan, M.D.

  Pathology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

  STUDY CHAIR

• Ahmad El-Hennawy, M.D.

  Pathology Department, Cairo University, Faculty of Medicine, Kasr El-Aini, Cairo, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Hepatology

Study Record Dates

• First Submitted: January 1, 2014
• First Posted: January 6, 2014
• Study Start: February 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

EG (3)