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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Secondary ID [1] 0 0
REDEMPTION
Universal Trial Number (UTN)
Trial acronym
REDEMPTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
4-7 months
Secondary outcome [1] 0 0
Side Effects - Collating common side effects on treatment
Timepoint [1] 0 0
3-6 months
Secondary outcome [2] 0 0
Rapid Virological Response (RVR) by HCV RNA PCR - Viral load 4 weeks after starting treatment as measured by HCV RNA PCR
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
End Of Treatment (EOT) Response by HCV RNA PCR - Viral load at end of treatment as measured by HCV RNA PCR
Timepoint [3] 0 0
3-6 months
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
6-12 months

Eligibility
Key inclusion criteria
Quantitative HCV RNA > 100
Minimum age
18 Years
Maximum age
82 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to DAA medications

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
FixHepC - Hobart
Recruitment postcode(s) [1] 0 0
7004 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
FixHepC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02657694
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Freeman, MB,BS,BSc
Address 0 0
ACRRM
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02657694