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TerminatedNCT00727077Updated Apr 8, 2015

Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)

An observational study in Hepatitis C, Chronic and Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational

Why this study was terminated
Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3
Ages
3 Years to 17 Years
Sex
All
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Study summary

The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus.

This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.

02

Conditions studied

03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 3 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children age 3 to 17 years, with chronic hepatitis C, treated in clinical practice at 10 German sites

Inclusion criteria

  • Patients with chronic hepatitis C (serum HCV-RNA-positive)
  • Age 3 to 17 years
  • Treatment-naïve
  • Platelets >= 100,000/mm\^3
  • Neutrophil counts >= 1,500/ mm\^3
  • TSH must be within normal limits
  • Hemoglobin >=12 g/dL (females); >=13 g/dL (males)
  • Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female subjects of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.
  • Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.

Exclusion criteria

Exclusion Criteria:

  • Contraindications according to the SPC and European approval
  • Pretreatment of chronic hepatitis C
  • Liver decompensation
  • Hypersensitivity to the active substance or to any interferons or to any of the excipients
  • Pregnant woman
  • Woman who are breast feeding
  • Existence of or history of psychiatric condition, in particular depression, suicidal ideation or suicide attempt
  • A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
  • Severe debilitating medical conditions, including patients with chronic renal failure or creatinine clearance \< 50 mlLmin
  • Autoimmune hepatitis or history of autoimmune disease
  • Severe hepatic dysfunction or decompensated cirrhosis of the liver
  • Pre- existing thyroid disease unless it can be controlled with conventional therapy
  • Epilepsy and/or compromised central nervous system function
  • Individual decision of physician if patient suitable for treatment (e.g., disturbance of growth)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3 participants (actual)

Groups and cohorts

  • IntronA/Rebetol

    Children age 3 to 17, with chronic hepatitis C, treated in clinical practice at 10 German sites

    Biological: IntronA (interferon alfa-2b; SCH 30500) · Drug: Rebetol (ribavirin; SCH 18908)

Interventions

  • BiologicalIntronA (interferon alfa-2b; SCH 30500)

    IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling

    Also known as: SCH 30500

  • DrugRebetol (ribavirin; SCH 18908)

    Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling

    Also known as: SCH 18908

06

What researchers measure

Primary outcomes

  1. Incidence of serious adverse events

    Time frame: After the inclusion of the subject in the study (defined as the time when the subject signs the informed consent) and up to 30 days after the subject completed or discontinued the study

Secondary outcomes

  1. Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)

    Time frame: Assessed at the end of treatment and 24 weeks post-treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00727077
Responsible party
Sponsor
First posted
Aug 1, 2008
Start date
Jun 2006
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Apr 8, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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