Multicenter randomized controlled study comparing the efficacy and safety of natural Multi-subtype interferon alpha (Multiferon) in association with ribavirin versus retreatment with pegylated interferon-alpha 2a and ribavirin in non-responding genotype 1 hepatitis C patients. - Must Have

• Conditions: Hepatitis C; MedDRA version: 12.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2009-018146-38-FR
• Lead Sponsor: Swedish Orphan International AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.Male or female between 18 and 65 years of age
2.Patient with documented genotype 1 chronic hepatitis C infection with detectable HCV RNA (> 25 IU/mL) in serum
3.Previous non response to peg-interferon plus ribavirin treatment, defined as patients with documented response of at least a 1 log decrease of their viral load at week 12 to a prior course of SOC who did not achieve undetectable HCV-RNA at the end of treatment. Can be included both:
3.1.Patient who had an undetectable HCV RNA level during prior course of Peg-IFN/ribavirin therapy but regained detectable HCV RNA before therapy ended (breakthrough patients);
or
3.2. Patients presenting, after 12 weeks of treatment with a viral decrease less than 2 log
or
3.3.Patients who did not achieve a negative viral load after 24 weeks of given treatment
4.Well-documented previous SOC treatment with peg-interferon and ribavirin with HCV RNA levels measured at baseline, at week 12, and at the end of the treatment period.
5.Patients who showed a compliance to previous treatment with peg-interferon and ribavirin of at least 80%
6.Patient has had a liver biopsy and/or Fibroscan evaluation within 1 year prior to study inclusion showing a metavir score of F3 or less or less than 10 kPA.
7.Screening laboratory values of the following variables must meet the acceptable values defined below: Laboratory Variable Acceptable Range
•Absolute neutrophil count = 1500/mm3
•Platelet count = 100000/mm3
•Haemoglobin = 12 g/dL for females = 13 g/dL for males
•Creatinine clearance > 50 ml/min
•Uric acid within normal range
•All other hematology and clinical chemistry results (except for transaminases) within normal limits or showing no clinically significant abnormalities
8.All fertile males must accept effective contraception for both themselves and their partners during treatment and during 7 months after the treatment ends and for the female partners to undergo pregnancy tests monthly during the same period. .
9. All fertile females must accept effective contraception for both themselves and their partner during treatment and during 4 months after the treatment ends and to undergo pregnancy tests monthly during the same period.
10.Patient is able to read and understand, and is willing to sign the Informed Consent Form (ICF) voluntarily before first trial-related activity
11.Patient agrees to not participate in other clinical trials

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients having an hypersensitivity to interferon-alpha or ribavirin or any of the excipients used in Multiferon, Copegus or Pegasys
2.Patient having intolerance or side effects during previous peg-interferon plus ribavirin treatment leading to discontinuation of at least one of the two drugs
3.Women who are pregnant, planning to become pregnant, or breastfeeding, and males whose partner plans to become pregnant
4.Patients having been treated by immunosuppressive agents within 6 months
5.Patients having received HCV antiviral drugs or any investigational drug within 12 weeks prior to study inclusion
6.Patient having an history of organ transplants that requires chronic immunosuppression
7.Epilepsy if not well controlled by conventional medication
8.Patients co-infected with HIV and/or hepatitis B
9.Suspicion of alcohol, barbiturate, or amphetamine recreational or of narcotic drug use, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with study procedures
10.Patient has a concomitant medical condition that in the opinion of the investigator could influence the results of the trial or that could represent an additional risk for the administration of the study drugs to the subject
11.Patient has medical contraindication to the administration of Peg-IFN alfa-2a or ribavirin, including, but not limited to:
?abnormal thyroid function not controlled effectively with conventional treatment;
?history of clinically significant pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous 6 months
?evidence of autoimmune disease;
?history of hemoglobinopathies(e.g. thalassemia, sickle-cell anaemia).
12.Pre-existing psychiatric condition that could interfere with the patient’s participation and completion of the study, including but not limited to:
?severe depression or hospitalization for depression;
?history of severe depression during the previous treatment with pegIFN and ribavirin
?schizophrenia, bipolar illness, severe anxiety or personality disorder;
?a period of disability or impairment due to a psychiatric disease within the past 5 years.
13.Subject has history of decompensated liver disease: history of ascites,hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
?International Normalized Ratio (INR) of = 1.5;
?Serum albumin < 3.3 g/dL;
?Serum total bilirubin > 1.8 times the upper limit of normal (ULN), unless isolated and for subjects with Gilbert’s Syndrome.
14.Any evidence of significant liver disease in addition to hepatitis C, which may include, but is not limited to, hepatitis B virus (HBV) infection, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, or primary biliary cirrhosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified