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

February 14, 2017 updated by: FixHepC
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Tasmania
      • Hobart, Tasmania, Australia, 7004
        • FixHepC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Worldwide, Hepatitis C Genotypes 1-6

Description

Inclusion Criteria:

Quantitative HCV RNA > 100

Exclusion Criteria:

Contraindications to DAA medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sofosbuvir+Ledipasvir
Following patients treating with Sofosbuvir+Ledipasvir
Drug: Sofosbuvir+Ledipasvir
DAA medication treatment
Other Names:
  • Harvoni (generic)
Sofosbuvir+Daclatasvir
Following patients treating with Sofosbuvir+Daclatasvir
Drug: Sofosbuvir+Daclatasvir
DAA medication treatment
Other Names:
  • Sovaldi (generic)
  • Daklinza (generic)
Sofosbuvir+Velpatasvir
Following patients treating with Sofosbuvir+Velpatasvir
Drug: Sofosbuvir+Velpatasvir
DAA medication treatment
Other Names:
  • Epclusa (generic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4-7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects
Time Frame: 3-6 months
Collating common side effects on treatment
3-6 months
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
4 weeks
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
3-6 months
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)
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FixHepC

Investigators

  • Study Director: James Freeman, MB,BS,BSc, ACRRM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDEMPTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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