Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron Plus REBETOL for Pediatric Patients with Chronic Hepatitis C
- Conditions
- Chronic hepatitis C
- Registration Number
- EUCTR2004-000558-22-ES
- Lead Sponsor
- Schering-Plough Research Insitute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 107
-History of chronic hepatitis C as documented either by anti-HCV or HCV RNA
positivity at least 6 months prior to Screening 1.
-Subjects 3 through 17 years of age (inclusive) at time of Screening 2, of either
gender.
-Plasma positive for HCV RNA by quantitative RT-PCR, as measured by the
sponsor's assay, during Screening 1 visit.
-Results of a liver biopsy performed prior to entry to the study are required
(except as noted below):
• Patients who have had a liver biopsy performed prior to consideration for
the study (historical liver biopsy) must have the pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (evidence of fibrosis and/or
inflammatory activity) and slides from this biopsy must be available
for assessment by the study central pathologist
• If no historical liver biopsy is available,
? All subjects with a history of transfusion-associated
chronic hepatitis C must have a pretreatment liver biopsy performed.
? Subjects 3-11 years old:
With a normal ALT level must have a pretreatment liver biopsy
performed.
With an elevated ALT level within 1 year prior to Screening 1 must
have a pretreatment liver biopsy requested of the subject/legal
guardian. If refused, the site should discuss the possible inclusion of
the subject into the study with the sponsor’s project physician.
? Subjects 12-17 years old must have a pretreatment liver biopsy
performed.
-Compensated liver disease with minimum hematologic, biochemical, and serologic criteria at the Screening 1 and 2 visits.
-Thyroid stimulating hormone (TSH), WNL.
-Antinuclear antibodies (ANA) =1:160 within 1 year of Screening 1 visit.
-Subjects with a history of mild depression and/or behavioral problems may be
considered for entry into this study provided that a pretreatment assessment
of the subject's affective status supports that the subject is clinically stable.
-All subjects must be willing to abstain from alcohol and any other illicit drugs
during the study.
-Reconfirmation and documentation that sexually active female and male subjects of childbearing potential are practicing adequate contraception.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
All subjects will be excluded from entry if any of the criteria listed below are
met:
-Serum ALT level >10 times the upper limit of normal within the 6 months prior
to Screening 1 visit.
-Any other cause for liver disease other than chronic hepatitis C.
-Evidence of decompensated liver disease.
-The most recent liver biopsy is normal.
-Prior treatment for chronic hepatitis C.
-Known coinfection with either HIV or HBV.
-Known immunodeficiency disorders requiring immunoglobulin therapy.
-Known coagulopathies, including hemophilia, or anticoagulant use.
-Known hemoglobinopathies.
-Known G6PD deficiency.
-Evidence of active or suspected malignancy, or a history of malignancy within
the last 5 years.
-Subjects with organ transplants.
-Subjects with clinically significant retinal abnormalities such as known
retinopathy of prematurity or other retinopathies.
-Any known pre-existing medical condition that could interfere with the
subject's participation in and completion of the study.
-Subjects who have a history of pregnancy or who are pregnant and/or breast
feeding. Subjects who intend to become pregnant during the study period.
Subjects with partners who intend to become pregnant during the study
period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method