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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100659
Recruitment Status : Completed
First Posted : January 5, 2005
Results First Posted : July 1, 2013
Last Update Posted : October 24, 2018
Roche Pharma AG
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Pegylated Interferon/ribavirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Study Start Date : December 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sustained Viral Response (SVR) [ Time Frame: at least 24 weeks after stopping treatment. ]
    SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: At any time up to 72 weeks ]
    Influenza-like, headache, and gastrointestinal symptoms

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 ribavirin/placebo tablet

Exclusion Criteria:

  • Any prior treatment with Interferon or ribavirin (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100659

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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Roche Pharma AG
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Principal Investigator: Kathleen B Schwarz, MD Johns Hopkins University
Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00100659    
Other Study ID Numbers: 67767 (completed)
U01DK067767 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2005    Key Record Dates
Results First Posted: July 1, 2013
Last Update Posted: October 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocols, manuals, and data will be posted at the NIDDK Central Repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data were posted to the NIDDK Central Repository in March 2013.
Access Criteria: Data can be requested from the NIDDK Central Repository. A signed data use agreement is required.
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
peginterferon alfa-2a
Pegylated Interferon
chronic hepatitis C
chronic hepatitis C virus
hepatitis c
pediatric hepatitis
pediatric HCV
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action