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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00104052
First received: February 22, 2005
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Biological: peginterferon alfa-2b (SCH 54031)
Drug: ribavirin (SCH 18908)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ]

Enrollment: 107
Study Start Date: February 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-Intron plus REBETOL
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.
Biological: peginterferon alfa-2b (SCH 54031)
60 µg/m2 subcutaneous injection once weekly for up to 48 weeks
Other Name: PEG-Intron (SCH 54031)
Drug: ribavirin (SCH 18908)
15 mg/kg/day for up to 48 weeks
Other Name: REBETOL (SCH 18908)

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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00104052     History of Changes
Other Study ID Numbers: P02538: Part 1
Study First Received: February 22, 2005
Results First Received: November 14, 2008
Last Updated: October 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Reaferon
Interferon Alfa-2b
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on April 22, 2014