Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04038320
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine
Sponsor:
Right to Care
Organization:
Study Overview
Official Title:
Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The project will evaluate cost and treatment outcomes of a simplified Hepatitis C Virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations in Ukraine.
Detailed Description:
Affected populations will be screened for HCV and HIV and those HCV positive treated with direct with direct acting anti-HCV agents (DAAs), a fixed-dose combination of sofosbuvir/ledipasvir (SOF/LDV) for 12 weeks with or without weight-based ribavirin. Before and after completion of the treatment course viral load assessments will be undertaken using low-cost laboratory monitoring for comparison to standard HCV viral load measurement. Up 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Response (SVR) will be determined. Safety monitoring will be undertaken at applicable visits for those on Ribavirin and all adverse events will be reported based on Good Clinical Practice (GCP). In addition to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of SVR at 12 weeks after end of treatment ( defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of SVR12. The project will be conducted at 2 treatment sites in Kiev.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: