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Trial Review
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02657694
Registration number
NCT02657694
Ethics application status
Date submitted
14/01/2016
Date registered
18/01/2016
Date last updated
16/02/2017
Titles & IDs
Public title
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
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Scientific title
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
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Secondary ID [1]
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REDEMPTION
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Universal Trial Number (UTN)
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Trial acronym
REDEMPTION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir+Ledipasvir
Treatment: Drugs - Sofosbuvir+Daclatasvir
Treatment: Drugs - Sofosbuvir+Velpatasvir
Sofosbuvir+Ledipasvir - Following patients treating with Sofosbuvir+Ledipasvir
Sofosbuvir+Daclatasvir - Following patients treating with Sofosbuvir+Daclatasvir
Sofosbuvir+Velpatasvir - Following patients treating with Sofosbuvir+Velpatasvir
Treatment: Drugs: Sofosbuvir+Ledipasvir
DAA medication treatment
Treatment: Drugs: Sofosbuvir+Daclatasvir
DAA medication treatment
Treatment: Drugs: Sofosbuvir+Velpatasvir
DAA medication treatment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)
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Assessment method [1]
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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)
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Timepoint [1]
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4-7 months
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Secondary outcome [1]
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Side Effects
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Assessment method [1]
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Collating common side effects on treatment
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Timepoint [1]
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3-6 months
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Secondary outcome [2]
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Rapid Virological Response (RVR) by HCV RNA PCR
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Assessment method [2]
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Viral load 4 weeks after starting treatment as measured by HCV RNA PCR
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Timepoint [2]
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4 weeks
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Secondary outcome [3]
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End Of Treatment (EOT) Response by HCV RNA PCR
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Assessment method [3]
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Viral load at end of treatment as measured by HCV RNA PCR
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Timepoint [3]
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3-6 months
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Secondary outcome [4]
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Sustained Virological Response (SVR12) by HCV RNA PCR
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Assessment method [4]
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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)
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Timepoint [4]
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6-12 months
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Eligibility
Key inclusion criteria
Quantitative HCV RNA > 100
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Minimum age
18
Years
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Maximum age
82
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Contraindications to DAA medications
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2018
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
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FixHepC - Hobart
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Recruitment postcode(s) [1]
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7004 - Hobart
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Funding & Sponsors
Primary sponsor type
Other
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Name
FixHepC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02657694
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James Freeman, MB,BS,BSc
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Address
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ACRRM
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02657694
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