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PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

NCT00100659•National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Eligibility

Age

5 - 18 years

Sex

ALL

Healthy Volunteers

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
+17 more criteria

Locations (11)

University of California, San Francisco

San Francisco, California, United States

The Children's Hospital

Denver, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Indiana University School of Medicine, James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Children's Hospital Boston

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 1, 2004

Primary Completion Date

August 1, 2008

Completion Date

February 1, 2010

Last Updated

October 24, 2018

Enrollment

114

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

Pegylated Interferon/ribavirin

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

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COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

View study

COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection