CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 565 enrolled
Drug / intervention
Ombitasvir/paritaprevir/ritonavir +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02581189
NCT02581189N/ACompleted
CompareCT.gov

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Canada (AMBER)

AbbVie·observational·Posted Oct 20, 2015·Updated Mar 27, 2019

In Brief

An observational study evaluating Ombitasvir/paritaprevir/ritonavir, Dasabuvir, and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 565 participants.

Detailed Summary

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Canada in a clinical practice patient population.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
Countries--
CollaboratorsIST GmbH, Germany, Cato Research

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 20, 2015
Enrollment StartOct 13, 2015
Primary CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.7 years ago

Interventions

Ombitasvir/paritaprevir/ritonavirdrug

Co-formulated tablet

Dasabuvirdrug

Tablet

Ribavirindrug

Tablet