Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT00100659
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2005-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kschwarz@jhmi.edu', 'phone': '410-955-8769', 'title': 'Kathleen B. Schwarz, M.D.', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pegylated Interferon/Ribavirin', 'description': 'Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.\n\nRibavirin - 15 mg per kg orally twice daily using 100-mg tablets.', 'otherNumAtRisk': 55, 'otherNumAffected': 51, 'seriousNumAtRisk': 55, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Pegylated Interferon/Placebo', 'description': '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).', 'otherNumAtRisk': 59, 'otherNumAffected': 52, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint and muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicide gesture', 'notes': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New onset diabetes mellitus Type 1', 'notes': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complications of a liver biopsy', 'notes': 'Hospitalization and cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Viral Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG/RV', 'description': 'Pegylated interferon/ribavirin'}, {'id': 'OG001', 'title': 'PEG/Placebo', 'description': 'Pegylated interferon/placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at least 24 weeks after stopping treatment.', 'description': 'SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon/Ribavirin', 'description': 'Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.\n\nRibavirin - 15 mg per kg orally twice daily using 100-mg tablets.\n\nPegylated Interferon/ribavirin'}, {'id': 'OG001', 'title': 'Pegylated Interferon/Placebo', 'description': '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).\n\nPegylated Interferon/ribavirin'}], 'classes': [{'title': 'Influenza-like symptoms', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any time up to 72 weeks', 'description': 'Influenza-like, headache, and gastrointestinal symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegylated Interferon/Ribavirin', 'description': 'Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.\n\nRibavirin - 15 mg per kg orally twice daily using 100-mg tablets.'}, {'id': 'FG001', 'title': 'Pegylated Interferon/Placebo', 'description': 'Placebo tablets were supplied in the same dosing regimen as ribavirin (RV), 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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'December 2004 to May 2006 at 11 US medical centers', 'preAssignmentDetails': 'Failure to meet inclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegylated Interferon/Ribavirin', 'description': 'Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.\n\nRibavirin - 15 mg per kg orally twice daily using 100-mg tablets.'}, {'id': 'BG001', 'title': 'Pegylated Interferon/Placebo', 'description': '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).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '10.8', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '10.75', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2005-01-04', 'resultsFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2005-01-04', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-10', 'studyFirstPostDateStruct': {'date': '2005-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Viral Response (SVR)', 'timeFrame': 'at least 24 weeks after stopping treatment.', 'description': 'SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'At any time up to 72 weeks', 'description': 'Influenza-like, headache, and gastrointestinal symptoms'}]}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '18042575', 'type': 'BACKGROUND', 'citation': 'Murray KF, Rodrigue JR, Gonzalez-Peralta RP, Shepherd J, Barton BA, Robuck PR, Schwarz KB; PEDS-C Clinical Research Network. Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection. Clin Trials. 2007;4(6):661-73. doi: 10.1177/1740774507085445.'}, {'pmid': '21351116', 'type': 'RESULT', 'citation': 'Rodrigue JR, Balistreri W, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Lobritto SJ, Schwarz KB, Robuck PR, Barton B, Gonzalez-Peralta RP. Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. Hepatology. 2011 May;53(5):1468-75. doi: 10.1002/hep.24248.'}, {'pmid': '21036173', 'type': 'RESULT', 'citation': 'Schwarz KB, Gonzalez-Peralta RP, Murray KF, Molleston JP, Haber BA, Jonas MM, Rosenthal P, Mohan P, Balistreri WF, Narkewicz MR, Smith L, Lobritto SJ, Rossi S, Valsamakis A, Goodman Z, Robuck PR, Barton BA; Peds-C Clinical Research Network. The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. Gastroenterology. 2011 Feb;140(2):450-458.e1. doi: 10.1053/j.gastro.2010.10.047. Epub 2010 Oct 28.'}, {'pmid': '18167062', 'type': 'RESULT', 'citation': 'Goodman ZD, Makhlouf HR, Liu L, Balistreri W, Gonzalez-Peralta RP, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Robuck PR, Schwarz KB. Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds-C Trial. Hepatology. 2008 Mar;47(3):836-43. doi: 10.1002/hep.22094.'}, {'pmid': '20512062', 'type': 'RESULT', 'citation': 'Narkewicz MR, Rosenthal P, Schwarz KB, Drack A, Margolis T, Repka MX; PEDS-C Study Group. Ophthalmologic complications in children with chronic hepatitis C treated with pegylated interferon. J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):183-6. doi: 10.1097/MPG.0b013e3181b99cf0.'}, {'pmid': '25313851', 'type': 'RESULT', 'citation': 'Delgado-Borrego A, Gonzalez-Peralta RP, Raza R, Negre B, Goodman ZD, Jonas MM, Chung RT, Ludwig DA; PEDS-C Clinical Research Network. Correlates of adiponectin in hepatitis C-infected children: the importance of body mass index. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):165-70. doi: 10.1097/MPG.0000000000000604.'}, {'pmid': '26284539', 'type': 'RESULT', 'citation': 'Schwarz KB, Molleston JP, Jonas MM, Wen J, Murray KF, Rosenthal P, Gonzalez-Peralta RP, Lobritto SJ, Mogul D, Pavlovic V, Warne C, Wat C, Thompson B. Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a +/- Ribavirin for Chronic Hepatitis C. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):93-6. doi: 10.1097/MPG.0000000000000929.'}, {'pmid': '23439301', 'type': 'DERIVED', 'citation': 'Molleston JP, Mellman W, Narkewicz MR, Balistreri WF, Gonzalez-Peralta RP, Jonas MM, Lobritto SJ, Mohan P, Murray KF, Njoku D, Rosenthal P, Barton BA, Talor MV, Cheng I, Schwarz KB, Haber BA; PEDS-C Clinical Research Network. Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):304-10. doi: 10.1097/MPG.0b013e3182774cae.'}, {'pmid': '22383118', 'type': 'DERIVED', 'citation': 'Jonas MM, Balistreri W, Gonzalez-Peralta RP, Haber B, Lobritto S, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Schwarz KB, Barton BA, Shepherd JA, Mitchell PD, Duggan C. Pegylated interferon for chronic hepatitis C in children affects growth and body composition: results from the pediatric study of hepatitis C (PEDS-C) trial. Hepatology. 2012 Aug;56(2):523-31. doi: 10.1002/hep.25690. Epub 2012 Jul 6.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening).\n* HCV viremia (by any test) present on 2 tests separated by at least 6 months.\n* 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.\n* Compensated liver disease (Child-Pugh Grade A clinical classification)\n* Signed informed consent from parent/legal guardian and willingness of parent/legal guardian to abide by the requirements of the study.\n* Hemoglobin values \\>11 g/dL for females; \\> 12 g/dL for males\n* Normal thyroid stimulating hormone (TSH)\n* Able to swallow a ribavirin/placebo tablet\n\nExclusion Criteria:\n\n* Any prior treatment with Interferon or ribavirin (RV)\n* Receipt of any investigational drug \\<6 weeks prior to the first dose of study drug\n* 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\n* Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab\n* 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))\n* History or other evidence of bleeding from esophageal varices\n* Decompensated liver disease (e.g. conjugated bilirubin \\>1.5mg/dl, ascites, varices, Child-Pugh Grade B or C clinical classification)\n* 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)\n* 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\n* Serum creatinine level \\>1.5 times the upper limit of normal for age\n* 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\n* History or other evidence of chronic pulmonary or cardiac disease associated with functional limitation\n* 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\n* Poorly controlled diabetes as defined by glycosylated hemoglobin of \\> 8%\n* History of solid organ or bone marrow transplantation\n* Evidence of severe retinopathy\n* Coagulopathy (international normalized ratio\\>1.5)\n* Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is \\>20% within 2 years.\n* Hemoglobinopathy\n* Hemophilia\n* Severe retinopathy\n* 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\n* 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\n* Females who have a positive serum pregnancy test within 7 days of initiation of treatment or who are breast-feeding\n* Males whose female partners are pregnant\n* Active substance abuse\n* A sibling and/or any other child living in the same household or sharing the same primary caregiver enrolled in the study.'}, 'identificationModule': {'nctId': 'NCT00100659', 'briefTitle': 'PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Pegylated Interferon +/- Ribavirin for Children With Hepatitis C', 'orgStudyIdInfo': {'id': '67767 (completed)'}, 'secondaryIdInfos': [{'id': 'U01DK067767', 'link': 'https://reporter.nih.gov/quickSearch/U01DK067767', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pegylated interferon/ribavirin', 'description': 'Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.\n\nRibavirin - 15 mg per kg orally twice daily using 100-mg tablets.', 'interventionNames': ['Drug: Pegylated Interferon/ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pegylated interferon/placebo', 'description': '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).', 'interventionNames': ['Drug: Pegylated Interferon/ribavirin']}], 'interventions': [{'name': 'Pegylated Interferon/ribavirin', 'type': 'DRUG', 'armGroupLabels': ['Pegylated interferon/placebo', 'Pegylated interferon/ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-0136', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '46202-5225', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine, James Whitcomb Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Kathleen B Schwarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'url': 'https://repository.niddk.nih.gov/studies/peds-c/?query=peds-c', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data were posted to the NIDDK Central Repository in March 2013.', 'ipdSharing': 'YES', 'description': 'Protocols, manuals, and data will be posted at the NIDDK Central Repository', 'accessCriteria': 'Data can be requested from the NIDDK Central Repository. A signed data use agreement is required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}