High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
A Comparative Study of High-dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
1 other identifier
interventional
33
1 country
1
Brief Summary
Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 27, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedSeptember 1, 2021
August 1, 2021
3.2 years
September 27, 2006
August 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW
week 4
Secondary Outcomes (2)
To compare the virological breakthrough/relapse rate after dose adjustments (at 4,24,72) weeks.
week 4, 24 and 72
To compare the sustained virological response rate at 24 weeks after end of treatment.
week 24 follow up
Study Arms (3)
360 PEG IFN
ACTIVE COMPARATOR360 mug peginterferon alfa-2a QW
9 MU + 180 PEG IFN
ACTIVE COMPARATOR9 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment
4,5 MU IFN + 180 PEG IFN
ACTIVE COMPARATOR4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment
Interventions
Eligibility Criteria
You may qualify if:
- chronic hepatitis C
- detectable serum HCV-RNA
- elevated serum ALT activity documented on at least two occasions within the past 12 months, with at least one during the 90 day screening period preceding the initiation of test drug dosing
- liver biopsy findings (during screening or within previous 12 months) consistent with active fibrosis (haemophiliacs are excluded from biopsies)
- compensated liver disease (Child-Pugh Grade A clinical classification)
- negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- all fertile males and females receiving ribavirin and their fertile or potentially fertile partners must be advised to use two forms of effective contraception (combined) during treatment and during the 6 months after end of treatment
You may not qualify if:
- history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
- women with ongoing pregnancy or breast feeding
- therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \<3 months prior to the first dose of study drug
- any investigational drug \<6 weeks prior to the first dose of study drug positive test at screening for HBsAg, anti-HIV Ab history or other evidence of bleeding from esophageal varices, ascites, or other conditions consistent with decompensated liver disease (Child-Pugh Grade B or C clinical classification)
- Signs or symptoms of hepatocellular carcinoma
- history or other strong evidence of a medical condition associated with chronic liver disease other than HCV (e.g., primary hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures
- Hb \<7.5 mmol/l in women or \<8.6 mmol/l in men at screening
- any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, etc) or for whom anaemia would be medically problematic neutrophil count \<1500 cells/mm3 or platelet count \<80,000 cells/mm3 at screening
- serum creatinine level \>1.5 times the upper limit of normal at screening
- history of severe psychiatric disease, especially depression
- history of a severe seizure disorder or current anticonvulsant use
- history of immunologically mediated disease
- history or other evidence of chronic pulmonary disease associated with functional limitation
- history of severe allergies
- history of symptomatic and/or significant cardiovascular disease
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus Medical Center
Rotterdam, 3015 CE, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rob J. de Knegt, MD, PhD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2006
First Posted
September 28, 2006
Study Start
February 1, 2003
Primary Completion
April 1, 2006
Study Completion
July 1, 2006
Last Updated
September 1, 2021
Record last verified: 2021-08