Status:
COMPLETED
An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
OneFlorida Clinical Research Consortium
Patient-Centered Outcomes Research Institute
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-88 years
Brief Summary
The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients wit...
Eligibility Criteria
Inclusion
- HCV viral load
- HCV genotype
- HCV qualitative
- HCV antibody
- HCV drug
- Continuously enrolled 12 months
Exclusion
- Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.
- The results will be examined for sensitivity to the following possible exclusion criteria:
- Achieved SVR-12 prior to index date
- HCV treatment experienced prior to index date
- No visit in GI, Infectious Disease, or Liver Transplant / Hepatology
- No positive HCV test (genotype, viral load, or qualitative)
- No recent positive HCV test (genotype, viral load or qualitative)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
33808 Patients enrolled
Trial Details
Trial ID
NCT03423641
Start Date
January 1 2011
End Date
December 31 2017
Last Update
August 7 2019
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