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

This study has been completed.
Information provided by:
Foundation for Liver Research Identifier:
First received: January 7, 2008
Last updated: March 10, 2011
Last verified: March 2011
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.

Condition Intervention Phase
Chronic Hepatitis C
Drug: interferon alfa-2b
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders

Resource links provided by NLM:

Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
12 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
Drug: interferon alfa-2b
12 MU daily continuously subcutaneous
Other Name: Intron A
Experimental: 2
9 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
Drug: interferon alfa-2b
9 MU daily continuously subcutaneous
Other Name: Intron A
Experimental: 3
6 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
Drug: interferon alfa-2b
6 MU daily continuously subcutaneous
Other Name: Intron A


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00624325

Erasmus University Medical Center
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
Foundation for Liver Research
Principal Investigator: R.J. de Knegt, MD, PhD Erasmus University Medical Center Rotterdam
  More Information

Responsible Party: R.J. de Knegt, Erasmus Medical Center Rotterdam Identifier: NCT00624325     History of Changes
Other Study ID Numbers: HCV 06-01
eudract 2006-000592-15
Study First Received: January 7, 2008
Last Updated: March 10, 2011

Keywords provided by Foundation for Liver Research:
genotype 1 nonresponders

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017