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Hepatitis C, ChronicPhase 3NCT00104052

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

A Phase 3 study testing peginterferon alfa-2b (PEG2b) (SCH 54031) and ribavirin (SCH 18908) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
peginterferon alfa-2b (PEG2b) (SCH 54031) and ribavirin (SCH 18908)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
No sites listed yet
Study dates
Feb 2005to Nov 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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,
Show all 19Show fewer
  • 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
  • No significant co-existing psychiatric disease
  • Those with diabetes, hypertension, or birth prior to 32 weeks gestational age must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given)
  • Patients and partners of patients willing to use adequate contraception during the course of the study
  • Abstain from alcohol and any other illicit drugs

Who cannot join

  • 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
Show all 20Show fewer
  • 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)
  • Insulin-dependent diabetes mellitus or poorly controlled non-insulin dependent diabetes mellitus
  • Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or symptomatic thyroid disorder)
  • History of substance abuse, including alcohol (e.g., binge drinking, blackouts), intravenous drugs and inhaled drugs
  • Subjects who have a history of pregnancy or who are pregnant and/or breast feeding. Subjects who intend to become pregnant during the study period. Subjects with partners who intend to become pregnant during the study period
  • Subjects with clinically significant retinal abnormalities such as known retinopathy of prematurity or other retinopathies

About this study

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

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.

Read the 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.

Being tested
peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called PEG-Intron (SCH 54031)

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

  • ribavirin (SCH 18908)Drug

    Also called REBETOL (SCH 18908)

    15 mg/kg/day for up to 48 weeks

Study groups in NCT00104052
Study groupRoleWhat they receive
PEG-Intron alfa 2b (PEG2b) plus REBETOL (RBV)ExperimentalPEG2b 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).
Receives: Biological: peginterferon alfa-2b (PEG2b) (SCH 54031); Drug: ribavirin (SCH 18908)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104052
Sponsor's protocol ID
P02538: Part 1
Status last verified
Mar 2017
First submitted
22 Feb 2005
Last updated
4 Apr 2017
Data monitoring committee
Yes
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 27111344

  • 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.

    PubMed 20189674

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing peginterferon alfa-2b (PEG2b) (SCH 54031) and ribavirin (SCH 18908) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment (time frame: Up to 48-week treatment duration. Follow-up of 24 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00104052, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.

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