Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

Hepatitis C Clinical Trial

— REDEMPTION  

Official title:

Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02657694
• Other study ID #: REDEMPTION
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 14, 2016
• Last updated: February 14, 2017
• Start date: July 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2017
• Source: FixHepC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: June 30, 2018
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

Quantitative HCV RNA > 100

Exclusion Criteria:

Contraindications to DAA medications

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Sofosbuvir+Ledipasvir
DAA medication treatment
• Sofosbuvir+Daclatasvir
DAA medication treatment
• Sofosbuvir+Velpatasvir
DAA medication treatment

Locations

Country	Name	City	State
Australia	FixHepC	Hobart	Tasmania

Sponsors (1)

Lead Sponsor	Collaborator
FixHepC

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)	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)	4-7 months
Secondary	Side Effects	Collating common side effects on treatment	3-6 months
Secondary	Rapid Virological Response (RVR) by HCV RNA PCR	Viral load 4 weeks after starting treatment as measured by HCV RNA PCR	4 weeks
Secondary	End Of Treatment (EOT) Response by HCV RNA PCR	Viral load at end of treatment as measured by HCV RNA PCR	3-6 months
Secondary	Sustained Virological Response (SVR12) by HCV RNA PCR	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)	6-12 months

External Links

•   REDEMPTION Website