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PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00100659
First received: January 4, 2005
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.

The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Pegylated Interferon/ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Sustained Viral Response (SVR) [ Time Frame: at least 24 weeks after stopping treatment. ] [ Designated as safety issue: No ]
    SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma


Secondary Outcome Measures:
  • Vital Signs Events. [ Time Frame: Every study visit ] [ Designated as safety issue: Yes ]
    Heart rate, blood pressure, respirations

  • Laboratory Assessments [ Time Frame: Every study visit ] [ Designated as safety issue: Yes ]
    complete blood count,blood urea nitrogen,creatinine, glucose,calcium, phosphorus, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase, bilirubin

  • Adverse Events [ Time Frame: Every study visit ] [ Designated as safety issue: Yes ]
    Influenza-like, headache, and gastrointestinal symptoms


Enrollment: 114
Study Start Date: December 2004
Study Completion Date: February 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pegylated interferon/ribavirin

Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.

Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets.

Drug: Pegylated Interferon/ribavirin
Placebo Comparator: Pegylated interferon/placebo
Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
Drug: Pegylated Interferon/ribavirin

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening).
  • HCV viremia (by any test) present on 2 tests separated by at least 6 months.
  • Chronic liver disease, as indicated by inflammation and/or fibrosis, consistent with chronic hepatitis C infection on a liver biopsy obtained within the past 24 months, as assessed by a qualified pathologist, not consistent with other known liver disease and not normal.
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • Signed informed consent from parent/legal guardian and willingness of parent/legal guardian to abide by the requirements of the study.
  • Hemoglobin values >11 g/dL for females; > 12 g/dL for males
  • Normal thyroid stimulating hormone (TSH)
  • Able to swallow a RV/placebo tablet

Exclusion Criteria:

  • Any prior treatment with Interferon or RV
  • Receipt of any investigational drug <6 weeks prior to the first dose of study drug
  • Any systemic antiviral therapy <6 weeks prior to the first dose of study drug. Exception: patients who have taken or are expected to require acyclovir for herpetic lesions
  • Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV (abnormal ceruloplasmin, alpha-1-antitrypsin, ANA>1:160, SMA>1:80, anti-LKM antibody > 60 units))
  • History or other evidence of bleeding from esophageal varices
  • Decompensated liver disease (e.g. conjugated bilirubin >1.5mg/dl, ascites, varices, Child-Pugh Grade B or C clinical classification)
  • History of autoimmune or immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical evidence of rheumatoid arthritis)
  • Absolute neutrophil count <1500 cells/mm3 , hemoglobin <11 g/dL for females and <12 g/dL for males, white blood count>17.5 x 109/L, or platelet count <90,000/ mm3
  • Serum creatinine level >1.5 times the upper limit of normal for age
  • Major depression according to the American Psychiatric Association, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicide attempt
  • History or other evidence of chronic pulmonary or cardiac disease associated with functional limitation
  • History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded
  • Poorly controlled diabetes as defined by glycosylated hemoglobin of > 8%
  • History of solid organ or bone marrow transplantation
  • Evidence of severe retinopathy
  • Coagulopathy (international normalized ratio>1.5)
  • Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >20% within 2 years.
  • Hemoglobinopathy
  • Hemophilia
  • Severe retinopathy
  • History of other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Sexually active females of child-bearing potential (defined as age 10 years and older) and sexually active men who are not practicing two forms of effective contraception during treatment and during the 6 months after treatment has been concluded
  • Females who have a positive serum pregnancy test within 7 days of initiation of treatment or who are breast-feeding
  • Males whose female partners are pregnant
  • Active substance abuse
  • A sibling and/or any other child living in the same household or sharing the same primary caregiver enrolled in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100659

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0136
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Indiana
Indiana University School of Medicine, James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Roche Pharma AG
Investigators
Principal Investigator: Kathleen B Schwarz, MD Johns Hopkins University
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00100659     History of Changes
Other Study ID Numbers: 67767 (completed)
Study First Received: January 4, 2005
Results First Received: May 10, 2013
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
pediatric
hepatitis
children
HCV
PEG
PEG-2a
peginterferon alfa-2a
Pegylated Interferon
RV
ribavirin
Pegasys
CHC
chronic hepatitis C
chronic hepatitis C virus
hepatitis c
pediatric hepatitis
pediatric HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014