Trials / Completed
CompletedNCT01070550
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)
Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,680 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<5000.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peginterferon alfa-2a (Pegasys®) | Peginterferon (PEG-IFN) alfa-2a Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks. |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2010-02-18
- Last updated
- 2016-06-15
- Results posted
- 2016-06-15
Locations
266 sites across 14 countries: Austria, Brazil, Canada, Croatia, France, Hungary, Mexico, Morocco, North Macedonia, Poland, Romania, Serbia, Slovenia, Sweden
Source: ClinicalTrials.gov record NCT01070550. Inclusion in this directory is not an endorsement.