Who is sponsoring NCT00127777?

NCT00127777 is sponsored by University Hospital, Saarland.

What condition does NCT00127777 study?

NCT00127777 studies Hepatitis C, Chronic.

What drugs are being tested in NCT00127777?

Interventions: Amantadine sulphate (in addition to standard treatment).

What is the status of NCT00127777?

NCT00127777 is currently UNKNOWN.

Last reviewed 2005-08-24 · How we verify

Randomized, Multi-Center, Partially Placebo-Controlled Phase IV-Study to Compare Efficacy and Tolerability of 48-Week Combined Therapy With Peginterferon Alfa-2a, Ribavirin and Amantadine Sulphate Versus Placebo in Untreated Patients With Chronic Hepatitis C Virus-Genotype-1-Infection

NCT00127777 Phase 4 UNKNOWN

This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in sustained response rate for triple therapy compared to current standard treatment.

Details

Lead sponsor	University Hospital, Saarland
Phase	Phase 4
Status	UNKNOWN
Enrolment	700
Start date	2002-07
Completion	2006-12

Conditions

Hepatitis C, Chronic

Interventions

Amantadine sulphate (in addition to standard treatment)

Primary outcomes

Proof that peginterferon alfa-2a, ribavirin and amantadine sulphate over a period of 50 weeks improves the permanent virological efficacy by more than 10% compared to peginterferon alfa-2a and ribavirin