- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517308
24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C
March 16, 2012 updated by: Prof. Guglielmo Borgia, Federico II University
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Naples, Italy, I-80131
- University of Naples Federico II
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Arm 24 weeks
PEG-IFN α2a 180 μg/week+ ribavirin 800 mg/die for 24 weeks
|
Comparison of different duration of drugs (48 weeks vs. 24 weeks)
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Experimental: Active arm (48 weeks)
PEG-IFN α2a 180 μg/week + ribavirin 800 mg/die per 48 weeks
|
Comparison of different duration of drugs (48 weeks vs. 24 weeks)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained virological response (SVR)
Time Frame: 6 months after therapy withdrawal
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HCV-RNA undetectability (by the means of Real time PCR assay with a sensitivity limit of 20 UI/mL) 6 months after therapy withdrawal.
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6 months after therapy withdrawal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guglielmo Borgia, Professor, Federico II University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
January 17, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Estimate)
March 19, 2012
Last Update Submitted That Met QC Criteria
March 16, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- C.E. Federico II 47/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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