Trials / Completed
CompletedNCT01337375
A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | peginterferon alfa 2a [Pegasys] | sc weekly |
| DRUG | peginterferon alfa-2a [Pegasys] | iv weekly |
| DRUG | peginterferon alfa-2a [Pegasys] | sc twice weekly |
| DRUG | peginterferon alfa-2a [Pegasys] | iv twice weekly |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2011-04-18
- Last updated
- 2016-11-02
Locations
5 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01337375. Inclusion in this directory is not an endorsement.