This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
FixHepC
ClinicalTrials.gov Identifier:
NCT02657694
First received: January 14, 2016
Last updated: February 14, 2017
Last verified: February 2017
History of Changes
January 14, 2016
February 14, 2017
July 1, 2015
January 1, 2017   (Final data collection date for primary outcome measure)
Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR) [ Time Frame: 4-7 months ]
Viral load 4 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA < Lower Limit Of Quantification (LLOQ)
Sustained Virological Response 4 (SVR4) [ Time Frame: 4-7 months ]
Viral load 4 weeks after cessation of treatment
Complete list of historical versions of study NCT02657694 on ClinicalTrials.gov Archive Site
  • Side Effects [ Time Frame: 3-6 months ]
    Collating common side effects on treatment
  • Rapid Virological Response (RVR) by HCV RNA PCR [ Time Frame: 4 weeks ]
    Viral load 4 weeks after starting treatment as measured by HCV RNA PCR
  • End Of Treatment (EOT) Response by HCV RNA PCR [ Time Frame: 3-6 months ]
    Viral load at end of treatment as measured by HCV RNA PCR
  • Sustained Virological Response (SVR12) by HCV RNA PCR [ Time Frame: 6-12 months ]
    Viral load 12 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA < Lower Limit Of Quantification (LLOQ)
  • Side Effects [ Time Frame: 3-6 months ]
    Collating common side effects on treatment
  • Rapid Virological Response (RVR) [ Time Frame: 4 weeks ]
    Viral load 4 weeks after starting treatment
  • End Of Treatment (EOT) [ Time Frame: 3-6 months ]
    Viral load at end of treatment
  • Sustained Virological Response (SVR12) [ Time Frame: 6-12 months ]
    Viral load 12 weeks after cessation of treatment
Not Provided
Not Provided
 
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
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.

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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample
Worldwide, Hepatitis C Genotypes 1-6
Hepatitis C
  • Drug: Sofosbuvir+Ledipasvir
    DAA medication treatment
    Other Name: Harvoni (generic)
  • Drug: Sofosbuvir+Daclatasvir
    DAA medication treatment
    Other Names:
    • Sovaldi (generic)
    • Daklinza (generic)
  • Drug: Sofosbuvir+Velpatasvir
    DAA medication treatment
    Other Name: Epclusa (generic)
  • Sofosbuvir+Ledipasvir
    Following patients treating with Sofosbuvir+Ledipasvir
    Intervention: Drug: Sofosbuvir+Ledipasvir
  • Sofosbuvir+Daclatasvir
    Following patients treating with Sofosbuvir+Daclatasvir
    Intervention: Drug: Sofosbuvir+Daclatasvir
  • Sofosbuvir+Velpatasvir
    Following patients treating with Sofosbuvir+Velpatasvir
    Intervention: Drug: Sofosbuvir+Velpatasvir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10000
June 30, 2018
January 1, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Quantitative HCV RNA > 100

Exclusion Criteria:

Contraindications to DAA medications
Sexes Eligible for Study: All
18 Years to 82 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT02657694
REDEMPTION
Yes
Not Provided
Plan to Share IPD: Yes
FixHepC
FixHepC
Not Provided
Study Director: James Freeman, MB,BS,BSc ACRRM
FixHepC
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP