At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 4
- ✓Confirmed chronic HCV genotype 1b with compensated liver cirrhosis
- ✓Treatment-naïve or prior interferon/ribavirin-experienced
- ✓Receiving or planning to initiate paritaprevir/r-ombitasvir + dasabuvir within ±2 weeks of enrollment
- ✓Not participating in concurrent interventional therapeutic trial
Key exclusion· 4
- ✕Co-administration of ribavirin with 3DAA regimen
- ✕Child-Pugh B or C cirrhosis (only compensated/A allowed)
- ✕Prior direct-acting antiviral (DAA) therapy
- ✕Any other contraindications per product label
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Real World Evidence Study of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir Without Ribavirin in Patients With Chronic HCV Gt1b Infection and Compensated Liver Cirrhosis in the RussIan FederaTion- An ObseRvational, MultI-CeNter Study (CITRIN)
In Brief
An observational study for Chronic Hepatitis C. Completed, enrolled 60 participants across 7 sites.
Detailed Summary
This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA \[direct-acting antiviral agent\] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesRussia
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartMar 2017
Primary CompletionDec 2017
TodayJul 2026
First PostedFeb 15, 2017
Enrollment StartMar 20, 2017
Primary CompletionDec 18, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.4 years ago