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
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.
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 →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.
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Children age 3 to 17 years, with chronic hepatitis C, treated in clinical practice at 10 German sites
Exclusion Criteria:
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)
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
Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling
Also known as: SCH 18908
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
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
No study locations are listed for this record.
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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