Chronic Hepatitis CPhase 4HAPICNCT01649245
Hansenula-derived Pegylated Interferon in Treatment of Patients With Chronic Hepatitis C
A Phase 4 study testing Reiferon retard in people with Chronic Hepatitis C, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
Trial summary
It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Reiferon retard
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 and < 60.
- BMI ≤ 30
- Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations.
- F1 stage (by Metavir scoring system) with elevated aminotransferases.
- Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin ≥ 3.5 g/dl, platelet count ≥ 1000 cmm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
- Acceptable hematological and biochemical indices (hemoglobin ≥ 11g/dl; total leukocytic count ≥ 3000/cmm, absolute neutrophil count ≥ 1500/cmm and serum creatinine < 1.97 mg/dl.
- Willing to be treated and to adhere to treatment requirements.
Who cannot join
- Major uncontrolled depressive illness.
- Solid organ transplantation.
- Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
- Untreated thyroid disease.
- Pregnant or unwilling to comply with adequate contraception.
- Severe concurrent medical disease, such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes (HbA1C > 8.5 %), and chronic obstructive pulmonary disease.
- Known hypersensitivity to drugs used to treat HCV.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Liver Institute
Shebin El-Kom, Monufia Governorate, 22213
Mohamed Kohla, MD, 002048222743, dr_mohamedsamy@yahoo.com
Imam Waked, MD
About this study
Official title: Efficacy and Safety of a Hansenula-derived Pegylated Interferon α2a (Reiferon Retard®) in Treatment of Patients With Chronic Hepatitis C Virus Infection: A National Multi-center Phase IV Open Label Non-Randomized Trial
It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks.
hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.
Read the detailed description
Multicenter , Phase IV, open labeled, non-randomized trial to assess the Efficacy of Hansenula-derived recombinant pegylated interferon α 2a (Reiferon Retard® in treatment of naïve chronic hepatitis c virus Egyptian patients.
Each participant will be subject to thorough history taking, complete clinical examination, Biochemical laboratory and hematological tests, U/S imaging as well as histologic assessment of liver disease stage and severity to ensure his/her eligibility to be enrolled in the study according to predetermined inclusion and exclusion criteria .
Eligible subjects will be treated with Reiferon Retard® 160 µg once weekly by subcutaneous injection for 48 weeks treatment plus weight-based Ribavirin orally (1200 mg/kg daily for those > 75 Kg or 1000mg/Kg daily for those ≤ 75 kg in divided doses). HCV RNA will be assessed at week 12 of initiation of therapy to identify Early Virologic Response (EVR), at week 24 to identify breakthrough viremia, at week 48 to identify End of treatment Response (ETR), and at week 72 to identify Sustained Virologic Response (SVR).
All subjects will be followed up during the study as described in the table below (Section 4 Study Design).
- Conditions
- Chronic Hepatitis C
- Being tested
- Reiferon retard
- Keywords
- Chronic hepatitis C, Egyptian patients, pegylated interferon, Ribavirin, Reiferon retard
- 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 retardDrug
Also called Pegylated interferon α 2a
Eligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is >75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses.
| Study group | Role | What they receive |
|---|---|---|
| Reiferon retard plus ribavirin | Experimental | Eligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is >75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses Receives: Drug: Reiferon retard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR)
Sustained Virologic Response (SVR) is assessed by measurement of HCV RNA viral load 24 weeks after the end of Therapy.
SVR is defined as undetectable HCV RNA 24 weeks after the end of therapy.
Measured: Assessed 24 weeks after the end of treatment
Secondary outcomes (3)
Complete Early Virologic Response (cEVR)
Complete Early Virologic Response (cEVR)is defined as undetectable HCV RNA at week 12 of therapy.
Measured: At week 12 of therapy
End of Treatment Response (ETR)
ETR is defined as undetectable HCV RNA at the end of therapy (at week 48)
Measured: at the end of therapy (48 weeks from initiation of therapy
Safety
Drug safety will be monitored throughout the treatment duration (48 weeks), and any moderate to severe adverse events will be reported
Measured: Throughout the duration of therapy (48weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinaPharm Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imam Waked, MD, Principal investigator, National Liver Institute, EgyptGamal Esmat, MD, Principal investigator, Faculty of Medicine - Cairo University - EgyptHassan Hamdy, MD, Principal investigator, Faculty of Medicine - Ain Shams University - EgyptMohamed kohla, MD, Study director, National Liver Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649245
- Sponsor's protocol ID
- HAPIC Trial
- Acronym
- HAPIC
- Status last verified
- Jan 2013
- First submitted
- 20 Jul 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Hansenula-derived Pegylated Interferon α2a (Reiferon Retard®) in Treatment of Patients With Chronic Hepatitis C Virus Infection: A National Multi-center Phase IV Open Label Non-Randomized Trial
- ClinicalTrials.gov ID
- NCT01649245
- Acronym / sponsor ID
- HAPIC / HAPIC Trial
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Egyptian patients, pegylated interferon, Ribavirin, Reiferon retard
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- MinaPharm PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 25 Jul 2012 (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.
It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks.
hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.
Detailed description
Multicenter , Phase IV, open labeled, non-randomized trial to assess the Efficacy of Hansenula-derived recombinant pegylated interferon α 2a (Reiferon Retard® in treatment of naïve chronic hepatitis c virus Egyptian patients.
Each participant will be subject to thorough history taking, complete clinical examination, Biochemical laboratory and hematological tests, U/S imaging as well as histologic assessment of liver disease stage and severity to ensure his/her eligibility to be enrolled in the study according to predetermined inclusion and exclusion criteria .
Eligible subjects will be treated with Reiferon Retard® 160 µg once weekly by subcutaneous injection for 48 weeks treatment plus weight-based Ribavirin orally (1200 mg/kg daily for those > 75 Kg or 1000mg/Kg daily for those ≤ 75 kg in divided doses). HCV RNA will be assessed at week 12 of initiation of therapy to identify Early Virologic Response (EVR), at week 24 to identify breakthrough viremia, at week 48 to identify End of treatment Response (ETR), and at week 72 to identify Sustained Virologic Response (SVR).
All subjects will be followed up during the study as described in the table below (Section 4 Study Design).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reiferon retard plus ribavirin | Experimental | Drug: Reiferon retardEligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is >75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age > 18 and < 60.
- BMI ≤ 30
- Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations.
- F1 stage (by Metavir scoring system) with elevated aminotransferases.
- Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin ≥ 3.5 g/dl, platelet count ≥ 1000 cmm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
Key exclusion criteria (7 listed)
- Major uncontrolled depressive illness.
- Solid organ transplantation.
- Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
- Untreated thyroid disease.
- Pregnant or unwilling to comply with adequate contraception.
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 retardAlso: Pegylated interferon α 2aEligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is >75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses. | Drug | Reiferon retard plus ribavirin |
Primary outcome
Sustained Virologic Response (SVR)
Time frame: Assessed 24 weeks after the end of treatment
Sustained Virologic Response (SVR) is assessed by measurement of HCV RNA viral load 24 weeks after the end of Therapy. SVR is defined as undetectable HCV RNA 24 weeks after the end of therapy.
3 secondary outcomes
Complete Early Virologic Response (cEVR)
Time frame: At week 12 of therapy
End of Treatment Response (ETR)
Time frame: at the end of therapy (48 weeks from initiation of therapy
Safety
Time frame: Throughout the duration of therapy (48weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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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.
Imam Waked, MD principal investigator
National Liver Institute, Egypt
Gamal Esmat, MD principal investigator
Faculty of Medicine - Cairo University - Egypt
Hassan Hamdy, MD principal investigator
Faculty of Medicine - Ain Shams University - Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reiferon retard in people with Chronic Hepatitis C, run by MinaPharm Pharmaceuticals at 1 site 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virologic Response (SVR) (time frame: Assessed 24 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2013.