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N/A Completed N=171

Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)

Source: ClinicalTrials.gov NCT02582658 ↗
Enrolled (actual)
171
Serious AEs
2.9%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 84.8 percentage of participants

Summary

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
84.8 —
SECONDARY
Percentage of Participants With Virological Response at End of Treatment (EoTR)
94.5 —
SECONDARY
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)
1.2 —
SECONDARY
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)
95.9 —
SECONDARY
Percentage of Participants With Post-treatment Relapse
0.0 —

Eligibility Criteria

Inclusion Criteria

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label

If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study

Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria

none

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02582658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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