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COMPLETEDPHASE3

Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)

Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C

NCT00104052•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.

Detailed Description

This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3 through 17 years, with chronic hepatitis C.

Eligibility

Age

3 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Children age 3-17 years old
•Individuals weighing ≤ 90 kg
•Previously untreated children with chronic hepatitis C (HCV RNA qPCR plasma positive)
•Individuals with any HCV (hepatitis C virus) genotype
•Hematology laboratory results of:
•* Hemoglobin (HGB) ≥ 11 g/dL for females or ≥ 12g/dL for males,
•* White Blood Cell Count (WBC) ≥ 3,000/mm\^3,
•* Neutrophils ≥ 1,500/mm\^3,
•* Platelets ≥ 100,000/mm\^3
•Chemistry laboratory results of:
+9 more criteria

Exclusion Criteria

•Serum ALT \>10 times the upper limit of normal within the 6 months prior to study
•Previous hepatitis C treatment
•Children with liver disease not caused by hepatitis C
•Most recent liver biopsy is normal
•Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
•Known blood disorders such as hemoglobinopathy, coagulopathy, or G6PD deficiency
•Known immunodeficiency disorders requiring immunoglobulin therapy
•Body organ transplant
•Any known or suspected cancer within the past 5 years
•Children with chronic pulmonary disease
+10 more criteria

Key Dates

Start Date

February 1, 2005

Primary Completion Date

November 1, 2007

Completion Date

November 1, 2007

Last Updated

April 4, 2017

Enrollment

107

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b (PEG2b) (SCH 54031)

BIOLOGICAL

ribavirin (SCH 18908)

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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Hepatitis C, Chronic

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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: April 4, 2017Data 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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Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection