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Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders (SCIN-C)

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ClinicalTrials.gov Identifier: NCT00624325
Recruitment Status : Completed
First Posted : February 27, 2008
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Foundation for Liver Research

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE February 27, 2008
Last Update Posted Date March 11, 2011
Study Start Date  ICMJE July 2007
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Safety and tolerability of high-dose continuous subcutaneous infused IFN-a2b (serious adverse events, grade 4 NCI toxicity, percentage of patients completing treatment or reasons for dose adjustments). [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
  • HCV RNA negativity at week 48 and 24 weeks after end of treatment [ Time Frame: 48 weeks ]
  • Biological activity of IFN-a2b [ Time Frame: 48 weeks ]
  • Pharmacokinetics by IFN-a2b levels [ Time Frame: 48 weeks ]
  • HCV-specific immune responses [ Time Frame: 48 weeks ]
  • Quality of life assessment using SF-36 and SCL-90 questionnaires [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
Official Title  ICMJE Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
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 combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: interferon alfa-2b
    12 MU daily continuously subcutaneous
    Other Name: Intron A
  • Drug: interferon alfa-2b
    9 MU daily continuously subcutaneous
    Other Name: Intron A
  • Drug: interferon alfa-2b
    6 MU daily continuously subcutaneous
    Other Name: Intron A
Study Arms  ICMJE
  • Experimental: 1
    12 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
    Intervention: Drug: interferon alfa-2b
  • Experimental: 2
    9 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
    Intervention: Drug: interferon alfa-2b
  • Experimental: 3
    6 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
    Intervention: Drug: interferon alfa-2b
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624325
Other Study ID Numbers  ICMJE HCV 06-01
eudract 2006-000592-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R.J. de Knegt, Erasmus Medical Center Rotterdam
Study Sponsor  ICMJE Foundation for Liver Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R.J. de Knegt, MD, PhD Erasmus University Medical Center Rotterdam
PRS Account Foundation for Liver Research
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP