Status:
COMPLETED
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
Lead Sponsor:
Foundation for Liver Research
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combinati...
Eligibility Criteria
Inclusion
- Hepatitis C genotype 1 unresponsive to (peg)interferon /ribavirin therapy
- In the past, peginterferon or conventional interferon plus ribavirin combination therapy for at least 12 weeks and less than 2-log HCV RNA decrease at week 12, HCV RNA positivity at week 24, breakthrough during therapy or relapse after therapy
- At least 12 weeks between end of (peg)interferon/ribavirin therapy and start of high-dose IFN/ribavirin therapy
- Persistent indication for antiviral therapy such as persistently elevated serum ALT or histological evidence of continuing or progressive fibrosis
- Age 18-60 years
Exclusion
- Signs of progressive liver disease since end of previous therapy, beyond generally accepted criteria for HCV antiviral therapy:
- serum bilirubin \>35 μmol/l, albumin \<36 g/l, prothrombin time \>4 sec prolonged or platelets \<100,000/mm3
- decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, gastric bleeding, esophageal varices or encephalopathy)
- Hepatic imaging (US, CT or MRI) with the evidence of hepatocellular carcinoma (hepatic imaging should be performed within 3 months prior to screening) or an alpha fetoprotein \>50 ng/ml
- Other acquired or inherited causes of liver disease that could explain liver disease activity
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- Other significant medical illness that might interfere with this study: significant cardiovascular, pulmonary or renal dysfunction, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g.: HIV positivity, steroid therapy, organ transplants other than cornea and hair transplant)
- History of a severe seizure disorder or current anticonvulsant use
- History of thyroid disease poorly controlled on prescribed medications
- Contra-indications for IFN and/or ribavirin:
- Severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression during previous (peg)interferon therapy. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the subject is clinically stable and that there is ongoing evaluation of the patient's mental status during the study
- Reactivation of immunological disorders during previous therapy
- Visual symptoms related to retinal abnormalities
- Pregnancy, breast-feeding or inadequate contraception
- Thalassemia, spherocytosis
- Substance abuse, such as alcohol (³80 gm/day) and I.V. drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00624325
Start Date
July 1 2007
End Date
December 1 2010
Last Update
March 11 2011
Active Locations (1)
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1
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 GD