Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT02657694
Status:
UNKNOWN
Last Update Posted:
2017-02-16
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Sponsor:
FixHepC
Organization:
Study Overview
Official Title:
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
ENROLLING_BY_INVITATION
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:
REDEMPTION
Brief Summary:
REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.
Detailed Description:
The high prices of Hepatitis C Virus (HCV) Direct Acting Antiviral (DAA) medications in many countries have led patients to seek out less expensive generic alternatives.
The efficacy and safety of these generic medications has not been formally demonstrated in clinical practice.
The primary goal of REDEMPTION is to collate the clinical results of these generic medications.
The secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.
The efficacy and safety of these generic medications has not been formally demonstrated in clinical practice.
The primary goal of REDEMPTION is to collate the clinical results of these generic medications.
The secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: