- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00624325
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders (SCIN-C)
March 10, 2011 updated by: Foundation for Liver Research
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- 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
-
-
-
Rotterdam, Netherlands, 3015 GD
- Erasmus University Medical Center
-
-
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 to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 |
---|---|
Experimental: 1
12 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
|
12 MU daily continuously subcutaneous
Other Names:
9 MU daily continuously subcutaneous
Other Names:
6 MU daily continuously subcutaneous
Other Names:
|
Experimental: 2
9 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
|
12 MU daily continuously subcutaneous
Other Names:
9 MU daily continuously subcutaneous
Other Names:
6 MU daily continuously subcutaneous
Other Names:
|
Experimental: 3
6 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
|
12 MU daily continuously subcutaneous
Other Names:
9 MU daily continuously subcutaneous
Other Names:
6 MU daily continuously subcutaneous
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HCV RNA negativity at week 48 and 24 weeks after end of treatment
Time Frame: 48 weeks
|
48 weeks
|
Biological activity of IFN-a2b
Time Frame: 48 weeks
|
48 weeks
|
Pharmacokinetics by IFN-a2b levels
Time Frame: 48 weeks
|
48 weeks
|
HCV-specific immune responses
Time Frame: 48 weeks
|
48 weeks
|
Quality of life assessment using SF-36 and SCL-90 questionnaires
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: R.J. de Knegt, MD, PhD, Erasmus Medical Center
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
July 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 7, 2008
First Submitted That Met QC Criteria
February 25, 2008
First Posted (Estimate)
February 27, 2008
Study Record Updates
Last Update Posted (Estimate)
March 11, 2011
Last Update Submitted That Met QC Criteria
March 10, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
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, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Interferon alpha-2
Other Study ID Numbers
- HCV 06-01
- eudract 2006-000592-15
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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