ClinicalTrials.Veeva

Menu

Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)

F

FixHepC

Status

Unknown

Conditions

Hepatitis C

Treatments

Drug: Sofosbuvir+Ledipasvir
Drug: Sofosbuvir+Velpatasvir
Drug: Sofosbuvir+Daclatasvir

Study type

Observational

Funder types

Other

Identifiers

NCT02657694
REDEMPTION

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

18 to 82 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Quantitative HCV RNA > 100

Exclusion criteria

Contraindications to DAA medications

Trial design

10,000 participants in 3 patient groups

Sofosbuvir+Ledipasvir
Description:
Following patients treating with Sofosbuvir+Ledipasvir
Treatment:
Drug: Sofosbuvir+Ledipasvir
Sofosbuvir+Daclatasvir
Description:
Following patients treating with Sofosbuvir+Daclatasvir
Treatment:
Drug: Sofosbuvir+Daclatasvir
Sofosbuvir+Velpatasvir
Description:
Following patients treating with Sofosbuvir+Velpatasvir
Treatment:
Drug: Sofosbuvir+Velpatasvir

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems