Chronic Hepatitis CPhase 3NCT01517308
24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C
A Phase 3 study testing pegylated interferon alpha 2a + ribavirin in people with Chronic Hepatitis C, run by Federico II University at 1 site in Italy.
Trial summary
Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- pegylated interferon alpha 2a + ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Nov 2015
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age more than 18 years
- Compensated liver disease with following pre-enrollment hematological parameters: Hemoglobin more than 13 g/dl in males and 12 g/dl in females; White blood cell count more than 3,000/mmc; Platelet count more than 100,000 /mmc
- Anti-nuclear antibodies (ANA) less than 1:160
- Anti-Liver-Kidney antibodies (LKM1): negative
- alpha1 fetoprotein levels less than 50 ng/ml in 3 months before enrollment and liver Ultrasound negative for focal malignant lesions.
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- HBsAg: negative
- Clinical or histological diagnosis of chronic hepatitis C
- HCV-RNA: positive
- Relapse (end-of-treatment HCV-RNA negativity and positivization within 6 months after therapy withdrawal) to at-least one previous treatment of PEG-IFN (alpha2a or alpha2b) + ribavirin which should have lasted at least for 80% of the 24 planned weeks with at least 80% of total planned dose of PEG-IFN and ribavirin administered.
- Normal values of total and direct bilirubin (with the exception of indirect bilirubin due to extrahepatic factors such as Gilbert syndrome; in these cases the levels should be less than 3 mg/dL).
- Normal values of albumin and creatinin
- Normal fasting glycemia or, in case of glycemic values between 115mg/dL and 140 mg/dl (values confirmed in more than one determination) or if the patient is affected by diabetes mellitus, glycated hemoglobin should be < 8,5%.
- Normal Thyroid Stimulating Hormone (TSH) level. Subjects under pharmacological treatment to maintain normal TSH levels can be enrolled if they fulfill other criteria.
- In case of history of diabetes or hypertension a specialist examination is required to rule out contraindication to therapy.
- Adoption of contraceptive measures
Who cannot join
- Age less than 18 years
- Women during pregnancy or breast-feeding
- Previous treatment with PEG-IFN alpha2a or alpha2b + ribavirin for more than 6 months
- Participation to any clinical trial within 30 days from enrollment in this protocol
- Subjects with solid organ transplantation (with the exception of cornea or hair transplantation)
- Subject not willing to have a counseling or to abstain from alcohol use
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- Suspected hypersensitivity to PEG-Interferon alpha2a or ribavirin
- Any other cause of liver disease different from chronic hepatitis C based on anamnesis of patient or on histological evidence including but not limited to:
- HBV coinfection
- Alpha-1 antitrypsin deficiency
- Wilson disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Hemoglobinopathy included but not limited to thalassemia major.
- Advanced liver diseases diagnosed through history or presence of ascites, esophageal variceal bleeding or hepatic encephalopathy
- Psychiatric conditions: depression or medical history of severe psychiatric alterations such as major psychosis, suicidal ideas, suicidal attempts, depression that required hospitalization or electroconvulsive therapy, prolonged work leave or significant impairment of everyday activities should be excluded. Subjects with history of slight depression might be considered for enrollment in the study if a pre-treatment psychiatric evaluation indicates that the subject is stable and that is possible to follow its mental status during the study.
- Central nervous system trauma or convulsive status requiring treatment.
- Cardiovascular diseases (e.g. angina, congestive heart disease, myocardial infarction, major arrhythmias).
- Decompensated diabetes mellitus
- Clinical gout
- Chronic pulmonary diseases
- Immune-mediated diseases (e.g. chronic inflammatory bowel diseases, idiopathic thrombocytopenic purpura, Systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
- Abuse of substances such as alcohol (more than 80 g/die), i.v. or inhalator drugs. Subjects with a history of drug abuse can be enrolled if they were abstinent for at least 2 years.
- Subjects with clinically relevant retinal lesions
- Any other condition that at investigators opinion could be a reason of non suitability for patients or can interfere with his/her participation to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C, RELAPSERS TO PEG-IFN + RIBAVIRIN TREATMENT. A RANDOMIZED CONTROLLED TRIAL
Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated whether 48 weeks of therapy may achieve better results compared to the standard duration (24 weeks).
- Conditions
- Chronic Hepatitis C
- Being tested
- pegylated interferon alpha 2a + ribavirin
- Keywords
- HCV, Hepatitis, Genotype 2 or 3, Pegylated Interferon, Duration
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon alpha 2a + ribavirinDrug
Comparison of different duration of drugs (48 weeks vs. 24 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Control Arm 24 weeks | Active comparator | PEG-IFN α2a 180 μg/week+ ribavirin 800 mg/die for 24 weeks Receives: Drug: pegylated interferon alpha 2a + ribavirin |
| Active arm (48 weeks) | Experimental | PEG-IFN α2a 180 μg/week + ribavirin 800 mg/die per 48 weeks Receives: Drug: pegylated interferon alpha 2a + ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (SVR)
HCV-RNA undetectability (by the means of Real time PCR assay with a sensitivity limit of 20 UI/mL) 6 months after therapy withdrawal.
Measured: 6 months after therapy withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: Time elapsed to require permissions and a recent paper showed a high efficacy of a 48-week regimen in this setting. It seems non-ethical to start this trial
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 Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guglielmo Borgia, Federico II University
- Investigators
- Guglielmo Borgia, Professor, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517308
- Sponsor's protocol ID
- C.E. Federico II 47/11
- Status last verified
- Mar 2012
- First submitted
- 17 Jan 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.
PubMed 17625124
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C, RELAPSERS TO PEG-IFN + RIBAVIRIN TREATMENT. A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01517308
- Acronym / sponsor ID
- C.E. Federico II 47/11
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV, Hepatitis, Genotype 2 or 3, Pegylated Interferon, Duration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Time elapsed to require permissions and a recent paper showed a high efficacy of a 48-week regimen in this setting. It seems non-ethical to start this trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 25 Jan 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.
Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated whether 48 weeks of therapy may achieve better results compared to the standard duration (24 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm 24 weeks | Active comparator | Drug: pegylated interferon alpha 2a + ribavirinPEG-IFN α2a 180 μg/week+ ribavirin 800 mg/die for 24 weeks |
| Active arm (48 weeks) | Experimental | Drug: pegylated interferon alpha 2a + ribavirinPEG-IFN α2a 180 μg/week + ribavirin 800 mg/die per 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent
- Age more than 18 years
- Compensated liver disease with following pre-enrollment hematological parameters: Hemoglobin more than 13 g/dl in males and 12 g/dl in females; White blood cell count more than 3,000/mmc; Platelet count more than 100,000 /mmc
- Anti-nuclear antibodies (ANA) less than 1:160
- Anti-Liver-Kidney antibodies (LKM1): negative
Key exclusion criteria (25 listed)
- Age less than 18 years
- Women during pregnancy or breast-feeding
- Previous treatment with PEG-IFN alpha2a or alpha2b + ribavirin for more than 6 months
- Participation to any clinical trial within 30 days from enrollment in this protocol
- Subjects with solid organ transplantation (with the exception of cornea or hair transplantation)
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 + ribavirinComparison of different duration of drugs (48 weeks vs. 24 weeks) | Drug | Active arm (48 weeks), Control Arm 24 weeks |
Primary outcome
Sustained virological response (SVR)
Time frame: 6 months after therapy withdrawal
HCV-RNA undetectability (by the means of Real time PCR assay with a sensitivity limit of 20 UI/mL) 6 months after therapy withdrawal.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Background: PubMed 17625124Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.
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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.
Guglielmo Borgia, Professor principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pegylated interferon alpha 2a + ribavirin in people with Chronic Hepatitis C, run by Federico II University at 1 site in Italy.
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 16 inclusion and 25 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: withdrawn, as of the sponsor's last update on 19 Mar 2012. 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 Italy. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sustained virological response (SVR) (time frame: 6 months after therapy withdrawal). 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 NCT01517308, 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 19 Mar 2012.