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NCT01066819 · ClinicalTrials.gov registry record
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
A clinical trial, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- 1,656
- Enrollment target
NCT01066819: Completed study, sponsored by Hoffmann-La Roche.
NCT01066819 is a clinical trial that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,656 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01066819 has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- 1,656 participants
- Enrollment target
Study 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) or peginterferon alfa-2b 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 \<2000.
Primary Outcome
Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high se
Interventions
- DRUG Peginterferon alfa-2a [Pegasys]
- DRUG Peginterferon alfa-2b [PegIntron®]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,656 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-08 |
What the finished NCT01066819 record still lists
NCT01066819 is an observational study that tracks outcomes without assigning an intervention. Its 1,656 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Peginterferon alfa-2a [Pegasys] is the first listed.
NCT01066819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01066819 about?
NCT01066819 is a clinical study titled "PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b". 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) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatmen...
What is the current status of trial NCT01066819?
This trial is currently completed. The enrollment target is 1,656 participants. The study started on 2008-01. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01066819?
The interventions under investigation include: Peginterferon alfa-2a [Pegasys] (DRUG), Peginterferon alfa-2b [PegIntron®] (DRUG).
Who is sponsoring clinical trial NCT01066819?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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