Hepatitis C, ChronicNCT02027493
Hansenula-Derived Pegylated-Interferon Alpha-2a in Egyptian Children With Chronic HCV
A study testing Reiferon R and Ribavirin in people with Hepatitis C, Chronic, run by National Liver Institute, Egypt at 3 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Reiferon R and Ribavirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesEgypt
- Study dates
- Feb 2009to Aug 2011
- Phase
- Interventional
- 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 3 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Department of Pediatrics, Cairo University Pediatric Hospital
Cairo, Cairo Governorate
Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
Cairo, 2851
National Liver Institute
Menoufiya, Menofiya, 32511
About this study
Official title: Safety and Efficacy of Hansenula-Derived Pegylated-Interferon Alpha-2a and Ribavirin Customized Combination Therapy in Egyptian Children With Chronic Hepatitis C Infection
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.
Read more
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
Read the detailed description
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,
- prolongation of treatment duration for up to 48 weeks regardless response type
- Shortening injection interval in some patients to every 5-day injection
- The third customization was the prolongation of treatment for extra 6 months, i.e. up tp 72 weeks in some patients.
The occurrence of adverse effects, virological and biochemical responses were assessed during treatment and follow up.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Reiferon R, Ribavirin
- Keywords
- Children, Chronic hepatitis C, Hansenula polymorpha, Pegylated interferon, Response rate, Ribavirin, Treatment
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiferon RDrug
Also called Hansenula-derived pegylated interferon alpha 2a, Reiferon Retard
subcutaneous injection of 100 μg/m2
RibavirinDrug
15 mg/kg daily on two divided doses
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Reiferon R; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (1)
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
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Yassin Abdelghaffar Charity Center for Liver Disease and Research, National Hepatology & Tropical Medicine Research Institute, Ain Shams University, Cairo University
- Responsible party
- Principal investigator, Mostafa M. Sira, National Liver Institute, Egypt
- Investigators
- Mostafa M Sira, M.D., Study director, Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, EgyptTawhida Y Abdel-Ghaffar, M.D., Principal investigator, Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, 2851 Cairo, EgyptSuzan El Naghi, M.D., Study director, Pediatric Department, National Hepatology and Tropical Medicine Research Institute, 11441 Cairo, EgyptHanaa El-Karaksy, M.D., Study chair, Cairo UniversityHeba Helmy, M.D., Study chair, Cairo UniversityMona S El-Raziky, M.D., Study chair, Cairo UniversityElham F Abdel-Aty, M.Sc., Study chair, Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, EgyptAleef A Allam, M.D., Study chair, Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027493
- Sponsor's protocol ID
- NLI-YAGCC-CUPH-HCV-PEG-PED
- Status last verified
- Jan 2014
- First submitted
- 1 Jan 2014
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24782620
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hansenula-Derived Pegylated-Interferon Alpha-2a and Ribavirin Customized Combination Therapy in Egyptian Children With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT02027493
- Acronym / sponsor ID
- NLI-YAGCC-CUPH-HCV-PEG-PED
- Conditions
- Hepatitis C, Chronic
- Keywords
- Children, Chronic hepatitis C, Hansenula polymorpha, Pegylated interferon, Response rate, Ribavirin, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Collaborators
- Yassin Abdelghaffar Charity Center for Liver Disease and Research, National Hepatology & Tropical Medicine Research Institute, Ain Shams University, Cairo University
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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,
- prolongation of treatment duration for up to 48 weeks regardless response type
- Shortening injection interval in some patients to every 5-day injection
- The third customization was the prolongation of treatment for extra 6 months, i.e. up tp 72 weeks in some patients.
The occurrence of adverse effects, virological and biochemical responses were assessed during treatment and follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiferon R weekly plus ribavirin | Active comparator | Drug: Reiferon R, Drug: Ribavirinpatients 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 |
| Reiferon R (every 5-day) plus ribavirin | Active comparator | Drug: Reiferon R, Drug: Ribavirinpatients 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 |
Who may qualify
- Ages
- 3 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- decompensated cirrhosis
- any other cause of liver disease associating HCV infection
- body mass index ≥ 95 percentile
- severe psychiatric conditions
- uncontrolled seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiferon RAlso: Hansenula-derived pegylated interferon alpha 2a, Reiferon Retardsubcutaneous injection of 100 μg/m2 | Drug | Reiferon R (every 5-day) plus ribavirin, Reiferon R weekly plus ribavirin |
| Ribavirin15 mg/kg daily on two divided doses | Drug | Reiferon R (every 5-day) plus ribavirin, Reiferon R weekly plus ribavirin |
Primary outcome
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
Time frame: 48 weeks
The efficacy and Safety was assessed during the 48 weeks of therapy, patients were monitored clinically, laboratory for the appearance of any side effects
1 secondary outcome
Efficacy of treatment customization on the outcome
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Derived from this study: PubMed 24782620El 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa M Sira, M.D. study director
Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt
Tawhida Y Abdel-Ghaffar, M.D. principal investigator
Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, 2851 Cairo, Egypt
Suzan El Naghi, M.D. study director
Pediatric Department, National Hepatology and Tropical Medicine Research Institute, 11441 Cairo, Egypt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiferon R and Ribavirin in people with Hepatitis C, Chronic, run by National Liver Institute, Egypt at 3 sites in Egypt.
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 12 inclusion and 11 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: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027493, which also lists 1 linked publication.
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 6 Jan 2014.