NCT00104052

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2005

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 9, 2009

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

February 22, 2005

Results QC Date

November 14, 2008

Last Update Submit

March 7, 2017

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment

    SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment

    Up to 48-week treatment duration. Follow-up of 24 weeks.

Study Arms (1)

PEG-Intron alfa 2b (PEG2b) plus REBETOL (RBV)

EXPERIMENTAL

PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) and RBV 400-1200 mg/day by mouth divided in 2 daily doses (administered twice daily with food, dosed 12 hours apart) for 48 weeks. Subjects treated up to 48 weeks and followed for additional 24 weeks after the end of treatment (total of 72 weeks study participation).

Biological: peginterferon alfa-2b (PEG2b) (SCH 54031)Drug: ribavirin (SCH 18908)

Interventions

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

PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks.

Also known as: PEG-Intron (SCH 54031)
PEG-Intron alfa 2b (PEG2b) plus REBETOL (RBV)
ribavirin (SCH 18908)DRUG

15 mg/kg/day for up to 48 weeks

Also known as: REBETOL (SCH 18908)
PEG-Intron alfa 2b (PEG2b) plus REBETOL (RBV)

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and Bilirubin,
  • Antinuclear antibody (ANA) ≤ 1:160,
  • Fasting Glucose 70-140 mg/dL. Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, HbA1C must be ≤ 8.5%
  • Compensated liver disease
  • Historic or pre-treatment liver biopsy slides available
  • +4 more criteria

You may not qualify if:

  • 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
  • Individuals who have a medical condition that would likely require systemic steroids
  • Those with a history of central nervous system (CNS) trauma or seizure disorders
  • Individuals with pre-existing psychiatric disorders including but not limited to moderate to severe depression
  • Current or previous use of lithium or antipsychotic drugs
  • Patients with clinically significant electrocardiogram (ECG) abnormalities and/or significant cardiovascular dysfunction (e.g., angina, congestive heart failure, recent myocardial infarction, uncontrolled hypertension, significant arrhythmia, cardiac sequelae from Kawasaki disease, cardiomyopathy, and/or history of congenital heart disease)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Haber B, Alonso E, Pedreira A, Rodriguez-Baez N, Ciocca M, Lacaille F, Lang T, Gonzalez T, Goodman Z, Yang Z, Jackson B, Noviello S, Albrecht JK. Long-Term Follow-Up of Children Treated With Peginterferon and Ribavirin for Hepatitis C Virus Infection. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):89-94. doi: 10.1097/MPG.0000000000001239.

    PMID: 27111344DERIVED

  • 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.

    PMID: 20189674DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2005

First Posted

February 23, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 4, 2017

Results First Posted

March 9, 2009

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php