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The study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. Additional analysis will differentiate between selected subpopulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with and without exposure |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12) | SVR12 defined as a documented undetectable viral load on or after week 12 following the end of treatment | Upto week 12 after the end of HCV treatment (SVR12) |
| Measure | Description | Time Frame |
|---|---|---|
| SVR12 in patients treated with DCV-containing regimens in real-life by treatment regimen, genotype, cirrhosis stage, HCV-treatment experience, HIV coinfection, and previous LTx (if present) | Upto week 12 after the end of HCV treatment (SVR12) | |
| Proportion of patients on DCV-containing regimens achieving SVR12 in real-life compared with SVR12 rates in clinical trials |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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Patients from private practices and outpatients units in hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hamburg | 20099 | Germany |
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| Upto week 12 after the end of HCV treatment (SVR12) |
| Safety of DCV-containing regimens in real-life measured by the incidence of (S)AEs and the incidence leading to treatment discontinuation | Until completion of study |
| Demographic and clinical characteristics and treatment patterns of patients starting a new HCV treatment regimen (with or without DCV), overall and by treatment regimen,GT,cirrhosis stage,HCV-treatment experience,HIV co-infection,and previous LTx | Previous LTx (if present) | Baseline (single assessment) |
| Comparison of demographic and clinical characteristics of patients starting a new HCV treatment regimen (with or without DCV) by treatment regimen and to identify factors associated with the initiation of different regimens | Baseline (single assessment) |
| SVR 24 in patients treated with DCV-containing regimens in real-life clinical care, change of Child-Pugh Score and Metavir score as well as change of patient related outcomes (EQ-5D and SF-36 questionnaires measuring quality of life) | Metavir score (liver function and histology) | Upto week 24 after the end of HCV treatment (SVR24) |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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