Self EfficacyPhase 2/3NCT01327729
Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C
A Phase 2/3 study testing pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg in people with Self Efficacy and Hepatitis C, run by BioGeneric Pharma at 1 site in Egypt.
Trial summary
The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV). Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Self Efficacy, Hepatitis C
- What is being tested?
- pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2010to May 2013
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 65 years
- Chronic hepatitis C defined as: HCV antibodies using a third generation test; HCV-RNA positive by PCR; liver biopsy in the past 12 months; METAVIR score of A1 and F0 or higher
- ALT > 1 ULN in the 24 weeks prior to inclusion (W-26; W-2)
- Patients never treated with ribavirin, Interferon or PEG-Interferon
- Normal albumin, prothrombin time > 60%; normal bilirubin
- Alpha-foeto-protein < 3 times the normal range for the laboratory reference
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- HBs antigen negative
- Anti Bilharzial antibodies if positive rectal snip shall be done. The examination may be repeated after praziquantel treatment for those with a positive test
- Hemoglobin > 11g/dl, leucocytes > 3000/mm3, neutrophils > 1500/mm3, platelets > 100 000/mm3, blood creatinin < 1.4 mg/dl
- Normal TSH (subjects needing treatment to maintain TSH within a normal range may be included if other eligibility criteria are respected)
- Anti-nuclear antibodies < 1/160
- Fasting blood sugar between 70-115mg/dl ; if glucose intolerance or diabetes, HbA1C < 8.5%
- Normal ophthalmologic examination in patients with history of blood pressure and/or diabetes
- Effective contraception (IUD, diaphragm and spermicide, condoms and spermicides, oral contraceptive, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-provera), tubal ligation, vasectomy) during the treatment period for females. No breastfeeding during the study period
- Signed informed consent
Who cannot join
- Other liver diseases associated with chronic hepatitis C: co-infection with hepatitis B (positive HBs antigen); hemochromatosis; alpha-1 anti-trypsin deficiency; Wilson disease; alcoholism-related liver disease; Gilbert disease
- Alcohol intake > 50g/day for males and 40 g/day for females
- Ongoing intravenous drug use
- Aggravated liver cirrhosis: history or presence of ascitis, oesophageal varicosis, liver encephalopathy
- Hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alaini school of medicne
Cairo, Cairo Governorate, 11559
Mohamed Karim f Ashour, MD
AMR H ELdeeb, MD
About this study
Official title: Clinical Trial of the Efficacy, Dosing, Safety and Tolerability of Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C
The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV).
Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)
Read the detailed description
Methods: Randomized, Open-label trial, in parallel groups (each of 100 patients). Treatment will be given for 48 weeks (positive HCV by polymerase chain reaction (PCR) patients at 24 weeks will be considered non responders) and follow-up for 24 weeks. Total treatment and follow-up duration: 72 weeks. Enrollment duration: 18 months. Total trial duration: 2 years and 9 month, including trial analysis (carried out in the 6 months following the follow-up completion of the last patient). Total number of patients: 300. Precision around the expected efficacy rate (45% in intention-to-treat analysis) will be 9.6% (α = 0.05).
Primary objective: to assess the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.
Secondary objective: To assess the plasma level of the YPEG-IFNα-2a in the first 30 patients in each group, to ensure therapeutic plasma level of the drug at 2 hours, 6 hours, 10 hours, 24 hours, 3 days, 5 days, 7 days, 10 days, 14 days and 28 days.
Treatment strategy:
Three groups in which each group will include 100 patients.
The first group will be treated with:
YPEG-IFN α-2a 180mcg/week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.
The second group will be treated with:
YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.
The third group will be treated with:
YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks. HCV RNA by PCR will be done at 24 weeks and negative PCR patients will continue treatment for another 24 weeks and PCR positive patients will be considered non responders and will be followed up.
Evaluation of the dose efficacy and side effects will be obtained at 4 weeks and 12 weeks of treatment, and any serious side effects or significant dose difference in early virological response in a group will lead to shift of this group to the dose 180 mcg/week.
Main outcome:
Viral clearance by qualitative HCV RNA based on PCR 24 weeks after the end of treatment.
Secondary outcomes:
Evaluation of HCV RNA at 12 and 24 weeks; changes in HCV RNA load during treatment; normalization of ALT during treatment and 24 weeks after the end of treatment; study of side effects; histological changes 24 weeks after the end of treatment: decrease by at least 1 point of the Metavir score.
- Conditions
- Self Efficacy, Hepatitis C
- Being tested
- pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
- Keywords
- pegylated interferon, interferon, HCV, genotype 4
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon alpha 2a YPEG-IFN α-2a 180mcgDrug
Also called YPEG-IFN α-2a 180mcg, YPEG, pegylated interferon
YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group
| Study group | Role | What they receive |
|---|---|---|
| YPEG-IFN α-2a one week | Active comparator | this arm will be treated with: YPEG-IFN α-2a 180mcg/ week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks Receives: Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg |
| YPEG-IFN α-2a Ten days | Active comparator | this arm will be treated with: YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks Receives: Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg |
| YPEG-IFN α-2a two weeks | Active comparator | The third group will be treated with:
YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks. Receives: Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral clearance at 72 weeks
assessment of the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.
Measured: 72 weeks
Secondary outcomes (1)
interferon level
assessment of the plasma level of the YPEG-IFNα-2a in the first 30 patients in each group, to ensure therapeutic plasma level of the drug at 2 hours, 6 hours, 10 hours, 24 hours, 3 days, 5 days, 7 days, 10 days, 14 days and 28 days.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2011 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGeneric Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Investigators
- Gamal Esmat, MD, Principal investigator, cairo university - Kasr alaini school of medicineMohamed Karim F Ashour, MD, Study director, Cairo university- Kasr Alaini school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327729
- Sponsor's protocol ID
- CHT00234
- Status last verified
- Mar 2011
- First submitted
- 31 Mar 2011
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Efficacy, Dosing, Safety and Tolerability of Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01327729
- Acronym / sponsor ID
- CHT00234
- Conditions
- Self Efficacy, Hepatitis C
- Keywords
- pegylated interferon, interferon, HCV, genotype 4
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BioGeneric PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 4 Apr 2011 (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.
The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV).
Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)
Detailed description
Methods: Randomized, Open-label trial, in parallel groups (each of 100 patients). Treatment will be given for 48 weeks (positive HCV by polymerase chain reaction (PCR) patients at 24 weeks will be considered non responders) and follow-up for 24 weeks. Total treatment and follow-up duration: 72 weeks. Enrollment duration: 18 months. Total trial duration: 2 years and 9 month, including trial analysis (carried out in the 6 months following the follow-up completion of the last patient). Total number of patients: 300. Precision around the expected efficacy rate (45% in intention-to-treat analysis) will be 9.6% (α = 0.05).
Primary objective: to assess the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.
Secondary objective: To assess the plasma level of the YPEG-IFNα-2a in the first 30 patients in each group, to ensure therapeutic plasma level of the drug at 2 hours, 6 hours, 10 hours, 24 hours, 3 days, 5 days, 7 days, 10 days, 14 days and 28 days.
Treatment strategy:
Three groups in which each group will include 100 patients.
The first group will be treated with:
YPEG-IFN α-2a 180mcg/week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.
The second group will be treated with:
YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.
The third group will be treated with:
YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks. HCV RNA by PCR will be done at 24 weeks and negative PCR patients will continue treatment for another 24 weeks and PCR positive patients will be considered non responders and will be followed up.
Evaluation of the dose efficacy and side effects will be obtained at 4 weeks and 12 weeks of treatment, and any serious side effects or significant dose difference in early virological response in a group will lead to shift of this group to the dose 180 mcg/week.
Main outcome:
Viral clearance by qualitative HCV RNA based on PCR 24 weeks after the end of treatment.
Secondary outcomes:
Evaluation of HCV RNA at 12 and 24 weeks; changes in HCV RNA load during treatment; normalization of ALT during treatment and 24 weeks after the end of treatment; study of side effects; histological changes 24 weeks after the end of treatment: decrease by at least 1 point of the Metavir score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YPEG-IFN α-2a one week | Active comparator | Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcgthis arm will be treated with: YPEG-IFN α-2a 180mcg/ week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks |
| YPEG-IFN α-2a Ten days | Active comparator | Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcgthis arm will be treated with: YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks |
| YPEG-IFN α-2a two weeks | Active comparator | Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcgThe third group will be treated with: YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age > 18 years and < 65 years
- Chronic hepatitis C defined as: HCV antibodies using a third generation test; HCV-RNA positive by PCR; liver biopsy in the past 12 months; METAVIR score of A1 and F0 or higher
- ALT > 1 ULN in the 24 weeks prior to inclusion (W-26; W-2)
- Patients never treated with ribavirin, Interferon or PEG-Interferon
- Normal albumin, prothrombin time > 60%; normal bilirubin
Key exclusion criteria (5 listed)
- Other liver diseases associated with chronic hepatitis C: co-infection with hepatitis B (positive HBs antigen); hemochromatosis; alpha-1 anti-trypsin deficiency; Wilson disease; alcoholism-related liver disease; Gilbert disease
- Alcohol intake > 50g/day for males and 40 g/day for females
- Ongoing intravenous drug use
- Aggravated liver cirrhosis: history or presence of ascitis, oesophageal varicosis, liver encephalopathy
- Hepatocellular carcinoma
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 |
|---|---|---|
| pegylated interferon alpha 2a YPEG-IFN α-2a 180mcgAlso: YPEG-IFN α-2a 180mcg, YPEG, pegylated interferonYPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group | Drug | YPEG-IFN α-2a Ten days, YPEG-IFN α-2a one week, YPEG-IFN α-2a two weeks |
Primary outcome
viral clearance at 72 weeks
Time frame: 72 weeks
assessment of the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.
1 secondary outcome
interferon level
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
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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.
Gamal Esmat, MD principal investigator
cairo university - Kasr alaini school of medicine
Mohamed Karim F Ashour, MD study director
Cairo university- Kasr Alaini school of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg in people with Self Efficacy and Hepatitis C, run by BioGeneric Pharma 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 15 inclusion and 5 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 4 Apr 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Mohamed Karim f Ashour, MD (0020123130102, drmkarim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viral clearance at 72 weeks (time frame: 72 weeks). 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 4 Apr 2011.