Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538AM1 Part 1)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	February 22, 2005
Last Updated Date	October 13, 2009
Start Date ^ICMJE	February 2005
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 5, 2009)	Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment [ Time Frame: Up to 48-week treatment duration. Follow-up of 24 weeks. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Proportion of subjects with a sustained virologic response (SVR) at 24 weeks post-treatment. [ Time Frame: Up to 48-week treatment duration. Follow-up of 24 weeks and then long-term follow-up of 5 years. ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00104052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Multiple-dose pharmacokinetics of PEG-Intron and REBETOL. [ Time Frame: Up to 48-week treatment duration. ] [ Designated as safety issue: No ]

Descriptive Information
Brief Title ^ICMJE	Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538AM1 Part 1)(COMPLETED)
Official Title ^ICMJE	Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C
Brief Summary	The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.
Detailed Description	This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3 through 17 years, with chronic hepatitis C.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Hepatitis C, Chronic
Intervention ^ICMJE	Biological: peginterferon alfa-2b (SCH 54031) Drug: ribavirin (SCH 18908)
Study Arms / Comparison Groups	Experimental: SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	107
Completion Date	November 2007
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Children age 3-17 years old Individuals weighing ≤ 90 kg Previously untreated children with chronic hepatitis C (HCV RNA qPCR plasma positive) Individuals with any HCV (hepatitis C virus) genotype Hematology laboratory results of: Hemoglobin (HGB) ≥ 11 g/dL for females or ≥ 12g/dL for males, White Blood Cell Count (WBC) ≥ 3,000/mm^3, Neutrophils ≥ 1,500/mm^3, Platelets ≥ 100,000/mm^3 Chemistry laboratory results of: Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and Bilirubin, Antinuclear antibody (ANA) ≤ 1:160, Fasting Glucose 70-140 mg/dL. Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, HbA1C must be ≤ 8.5% Compensated liver disease Historic or pre-treatment liver biopsy slides available No significant co-existing psychiatric disease Those with diabetes, hypertension, or birth prior to 32 weeks gestational age must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given) Patients and partners of patients willing to use adequate contraception during the course of the study Abstain from alcohol and any other illicit drugs Exclusion Criteria: Serum ALT >10 times the upper limit of normal within the 6 months prior to study Previous hepatitis C treatment Children with liver disease not caused by hepatitis C Most recent liver biopsy is normal Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV) Known blood disorders such as hemoglobinopathy, coagulopathy, or G6PD deficiency Known immunodeficiency disorders requiring immunoglobulin therapy Body organ transplant Any known or suspected cancer within the past 5 years Children with chronic pulmonary disease Individuals who have a medical condition that would likely require systemic steroids Those with a history of central nervous system (CNS) trauma or seizure disorders Individuals with pre-existing psychiatric disorders including but not limited to moderate to severe depression Current or previous use of lithium or antipsychotic drugs Patients with clinically significant electrocardiogram (ECG) abnormalities and/or significant cardiovascular dysfunction (e.g., angina, congestive heart failure, recent myocardial infarction, uncontrolled hypertension, significant arrhythmia, cardiac sequelae from Kawasaki disease, cardiomyopathy, and/or history of congenital heart disease) Insulin-dependent diabetes mellitus or poorly controlled non-insulin dependent diabetes mellitus Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or symptomatic thyroid disorder) History of substance abuse, including alcohol (e.g., binge drinking, blackouts), intravenous drugs and inhaled drugs 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 Subjects with clinically significant retinal abnormalities such as known retinopathy of prematurity or other retinopathies
Gender	Both
Ages	3 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00104052
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P02538: Part 1
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP