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NCT01508130 · ClinicalTrials.gov registry record
An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
A clinical trial, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- 672
- Enrollment target
NCT01508130: Completed study, sponsored by Hoffmann-La Roche.
NCT01508130 is a clinical trial that has completed, run by Hoffmann-La Roche. The registered enrollment target is 672 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01508130 has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- 672 participants
- Enrollment target
Study Summary
This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.
Primary Outcome
Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2012-01-31 |
| Est. Completion | 2014-03-31 |
What the finished NCT01508130 record still lists
NCT01508130 is an observational study that tracks outcomes without assigning an intervention. The registered 672 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01508130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01508130 about?
NCT01508130 is a clinical study titled "An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1". This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir ...
What is the current status of trial NCT01508130?
This trial is currently completed. The enrollment target is 672 participants. The study started on 2012-01-31. Estimated completion is 2014-03-31.
Who is sponsoring clinical trial NCT01508130?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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