NCT02657694

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

January 14, 2016

Last Update Submit

February 14, 2017

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Side Effects

    3-6 months

  • Rapid Virological Response (RVR) by HCV RNA PCR

    4 weeks

  • End Of Treatment (EOT) Response by HCV RNA PCR

    3-6 months

  • Sustained Virological Response (SVR12) by HCV RNA PCR

    6-12 months

Study Arms (3)

Sofosbuvir+Ledipasvir

Following patients treating with Sofosbuvir+Ledipasvir

Drug: Sofosbuvir+Ledipasvir

Sofosbuvir+Daclatasvir

Following patients treating with Sofosbuvir+Daclatasvir

Drug: Sofosbuvir+Daclatasvir

Sofosbuvir+Velpatasvir

Following patients treating with Sofosbuvir+Velpatasvir

Drug: Sofosbuvir+Velpatasvir

Interventions

Sofosbuvir+LedipasvirDRUG

DAA medication treatment

Also known as: Harvoni (generic)
Sofosbuvir+Ledipasvir
Sofosbuvir+DaclatasvirDRUG

DAA medication treatment

Also known as: Sovaldi (generic), Daklinza (generic)
Sofosbuvir+Daclatasvir
Sofosbuvir+VelpatasvirDRUG

DAA medication treatment

Also known as: Epclusa (generic)
Sofosbuvir+Velpatasvir

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Worldwide, Hepatitis C Genotypes 1-6

You may qualify if:

  • Quantitative HCV RNA \> 100

You may not qualify if:

  • Contraindications to DAA medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FixHepC

Hobart, Tasmania, 7004, Australia

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combinationDrugs, GenericSofosbuvirdaclatasvirsofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsUridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • James Freeman, MB,BS,BSc

    ACRRM

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

July 1, 2015

Primary Completion

January 1, 2017

Study Completion

June 30, 2018

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations

AU(1)