Who is sponsoring NCT00104052?

NCT00104052 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT00104052 study?

NCT00104052 studies Hepatitis C, Chronic.

What drugs are being tested in NCT00104052?

Interventions: peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908).

What is the status of NCT00104052?

NCT00104052 is currently COMPLETED.

Last reviewed 2017-03-07 · How we verify

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

NCT00104052 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	107
Start date	2005-02
Completion	2007-11

Conditions

Hepatitis C, Chronic

Interventions

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

Primary outcomes

Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment — Up to 48-week treatment duration. Follow-up of 24 weeks.
SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment