Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 7:52 AM
Study NCT ID:
NCT00761735
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2008-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006505', 'term': 'Hepatitis'}, {'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': 'C417083', 'term': 'peginterferon alfa-2b'}, {'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': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (1) proprietary information that is protected, (2) the accuracy of the information contained in the publication, and (3) to ensure that the presentation is fairly balanced and in compliance with FDA regulations.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years, starting after the Part 1 post-treatment Follow-up Week 24 visit', 'description': 'Only serious adverse events were collected during this 5 year LTFU study.', 'eventGroups': [{'id': 'EG000', 'title': 'PEG-IFN + RBV: LTFU', 'description': 'Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Talipes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Relapsed At End of LTFU Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG-IFN + RBV: LTFU (All)', 'description': 'Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 2 LTFU Year 5', 'description': 'Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.'}, {'type': 'PRIMARY', 'title': 'Mean Height Percentiles of Participants Over LTFU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG-IFN + RBV: LTFU (24 Weeks)', 'description': 'Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}, {'id': 'OG001', 'title': 'PEG-IFN + RBV: LTFU (48 Weeks)', 'description': 'Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'classes': [{'title': 'Part 1 Pre-treatment Baseline', 'categories': [{'measurements': [{'value': '48.94', 'spread': '27.38', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '29.98', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 1 (n=40, n=44)', 'categories': [{'measurements': [{'value': '49.21', 'spread': '29.03', 'groupId': 'OG000'}, {'value': '43.37', 'spread': '27.87', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 2 (n=39, n=39)', 'categories': [{'measurements': [{'value': '50.56', 'spread': '29.18', 'groupId': 'OG000'}, {'value': '46.24', 'spread': '29.19', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 3 (n=39, n=44)', 'categories': [{'measurements': [{'value': '48.05', 'spread': '28.38', 'groupId': 'OG000'}, {'value': '46.00', 'spread': '28.24', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 4 (n=40, n=38)', 'categories': [{'measurements': [{'value': '49.62', 'spread': '30.87', 'groupId': 'OG000'}, {'value': '45.27', 'spread': '29.44', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 5 (n=38, n=42)', 'categories': [{'measurements': [{'value': '47.61', 'spread': '29.57', 'groupId': 'OG000'}, {'value': '43.51', 'spread': '27.57', 'groupId': 'OG001'}]}]}, {'title': 'Last Available LTFU Visit (n=46, n=48)', 'categories': [{'measurements': [{'value': '45.96', 'spread': '30.45', 'groupId': 'OG000'}, {'value': '43.56', 'spread': '27.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)', 'description': 'To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Weight Percentiles of Participants Over LTFU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG-IFN + RBV: LTFU (24 Weeks)', 'description': 'Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}, {'id': 'OG001', 'title': 'PEG-IFN + RBV: LTFU (48 Weeks)', 'description': 'Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'classes': [{'title': 'Part 1 Pre-treatment Baseline', 'categories': [{'measurements': [{'value': '52.5', 'spread': '26.83', 'groupId': 'OG000'}, {'value': '58.56', 'spread': '30.56', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 1 (n=40, n=44)', 'categories': [{'measurements': [{'value': '53.62', 'spread': '26.75', 'groupId': 'OG000'}, {'value': '56.38', 'spread': '30.55', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 2 (n=39, n=39)', 'categories': [{'measurements': [{'value': '51.73', 'spread': '26.89', 'groupId': 'OG000'}, {'value': '52.03', 'spread': '30.47', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 3 (n=39, n=44)', 'categories': [{'measurements': [{'value': '53.18', 'spread': '29.12', 'groupId': 'OG000'}, {'value': '54.26', 'spread': '30.37', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 4 (n=40, n=38)', 'categories': [{'measurements': [{'value': '51.75', 'spread': '28.90', 'groupId': 'OG000'}, {'value': '49.50', 'spread': '30.37', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 5 (n=38, n=42)', 'categories': [{'measurements': [{'value': '51.16', 'spread': '27.16', 'groupId': 'OG000'}, {'value': '53.12', 'spread': '31.38', 'groupId': 'OG001'}]}]}, {'title': 'Last Available LTFU Visit (n=46, n=48)', 'categories': [{'measurements': [{'value': '50.15', 'spread': '28.44', 'groupId': 'OG000'}, {'value': '55.53', 'spread': '30.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)', 'description': 'To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG-IFN + RBV: LTFU (24 Weeks)', 'description': 'Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}, {'id': 'OG001', 'title': 'PEG-IFN + RBV: LTFU (48 Weeks)', 'description': 'Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'classes': [{'title': 'Part 1 Pre-treatment Baseline', 'categories': [{'measurements': [{'value': '50.4', 'spread': '29.63', 'groupId': 'OG000'}, {'value': '59.76', 'spread': '31.52', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 1 (n=40, n=44)', 'categories': [{'measurements': [{'value': '51.15', 'spread': '30.27', 'groupId': 'OG000'}, {'value': '59.91', 'spread': '31.55', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 2 (n=39, n=39)', 'categories': [{'measurements': [{'value': '48.11', 'spread': '29.59', 'groupId': 'OG000'}, {'value': '52.89', 'spread': '30.82', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 3 (n=39, n=44)', 'categories': [{'measurements': [{'value': '52.14', 'spread': '31.00', 'groupId': 'OG000'}, {'value': '54.96', 'spread': '30.89', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 4 (n=40, n=38)', 'categories': [{'measurements': [{'value': '48.44', 'spread': '30.46', 'groupId': 'OG000'}, {'value': '48.69', 'spread': '31.52', 'groupId': 'OG001'}]}]}, {'title': 'LTFU Year 5 (n=38, n=42)', 'categories': [{'measurements': [{'value': '48.61', 'spread': '29.72', 'groupId': 'OG000'}, {'value': '52.34', 'spread': '31.87', 'groupId': 'OG001'}]}]}, {'title': 'Last Available LTFU Visit (n=46, n=48)', 'categories': [{'measurements': [{'value': '48.79', 'spread': '29.40', 'groupId': 'OG000'}, {'value': '55.38', 'spread': '31.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)', 'description': 'To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG-IFN + RBV: LTFU (Female)', 'description': 'Female pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}, {'id': 'OG001', 'title': 'PEG-IFN + RBV: LTFU (Male)', 'description': 'Male pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'classes': [{'title': 'Age of TS 1 participants (n=4, n=5)', 'categories': [{'measurements': [{'value': '9.75', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '11.00', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Age of TS 2 participants (n=5, n=3)', 'categories': [{'measurements': [{'value': '11.86', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '12.53', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Age of TS 3 participants (n=7, n=1)', 'categories': [{'measurements': [{'value': '15.26', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '13.60', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Age of TS 4 participants (n=4, n=6)', 'categories': [{'measurements': [{'value': '16.00', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '14.75', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Age of TS 5 participants (n=21, n=27)', 'categories': [{'measurements': [{'value': '17.37', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '19.18', 'spread': '2.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last assessment of the Part 2 LTFU (up to 5 years)', 'description': 'The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PEG-IFN + RBV: LTFU', 'description': 'Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of 107 participants who enrolled in Part 1 of this study and were potentially eligible for the Part 2 Long Term Follow-up (LTFU), 94 participants enrolled in the current LTFU study (Part 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PEG-IFN + RBV: LTFU', 'description': 'Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2008-09-05', 'resultsFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2008-09-26', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-28', 'studyFirstPostDateStruct': {'date': '2008-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Relapsed At End of LTFU Year 5', 'timeFrame': 'Part 2 LTFU Year 5', 'description': 'Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.'}, {'measure': 'Mean Height Percentiles of Participants Over LTFU', 'timeFrame': 'Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)', 'description': 'To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.'}, {'measure': 'Mean Weight Percentiles of Participants Over LTFU', 'timeFrame': 'Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)', 'description': 'To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.'}, {'measure': 'Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU', 'timeFrame': 'Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)', 'description': 'To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.'}, {'measure': 'Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender', 'timeFrame': 'Last assessment of the Part 2 LTFU (up to 5 years)', 'description': 'The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '20189674', 'type': 'DERIVED', 'citation': 'Wirth S, Ribes-Koninckx C, Calzado MA, Bortolotti F, Zancan L, Jara P, Shelton M, Kerkar N, Galoppo M, Pedreira A, Rodriguez-Baez N, Ciocca M, Lachaux A, Lacaille F, Lang T, Kullmer U, Huber WD, Gonzalez T, Pollack H, Alonso E, Broue P, Ramakrishna J, Neigut D, Valle-Segarra AD, Hunter B, Goodman Z, Xu CR, Zheng H, Noviello S, Sniukiene V, Brass C, Albrecht JK. High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. J Hepatol. 2010 Apr;52(4):501-7. doi: 10.1016/j.jhep.2010.01.016. Epub 2010 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug therapy will be administered during the P02538 Part 2 study. Durability of virologic response will be assessed for participants who attained sustained virologic response (SVR) in Part I of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In addition, this study will characterize long-term safety in all participants who received PEG-IFN plus RBV treatment.', 'detailedDescription': "During the Part 2 LTFU, participants will be evaluated at Years 1, 2, 3, 4, and 5. Each participant's first LTFU visit will be scheduled approximately 1 year after the post-treatment Follow-up Week 24 visit in Part 1 of this study (NCT00104052)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.\n* The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.\n* The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants whether sustained responders, relapsers, or nonresponders are eligible to participate.\n\nExclusion Criteria:\n\n* Concurrent participation in any other clinical study.\n* Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.\n* Any condition that in the opinion of the Investigator would make the participant unsuitable for enrollment."}, 'identificationModule': {'nctId': 'NCT00761735', 'briefTitle': '5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'P02538: Part 2'}, 'secondaryIdInfos': [{'id': '2004-000558-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PEG-IFN + RBV: LTFU', 'description': 'Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.', 'interventionNames': ['Biological: Peginterferon alfa-2b', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Peginterferon alfa-2b', 'type': 'BIOLOGICAL', 'otherNames': ['PEG-Intron®'], 'description': 'In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m\\^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).', 'armGroupLabels': ['PEG-IFN + RBV: LTFU']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['REBETOL®'], 'description': 'In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).', 'armGroupLabels': ['PEG-IFN + RBV: LTFU']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}