Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02657694
Registration number
NCT02657694
Ethics application status
Date submitted
14/01/2016
Date registered
18/01/2016
Titles & IDs
Public title
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Query!
Scientific title
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Query!
Secondary ID [1]
0
0
REDEMPTION
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
REDEMPTION
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Observational [Patient Registry]
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)
Query!
Assessment method [1]
0
0
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)
Query!
Timepoint [1]
0
0
4-7 months
Query!
Secondary outcome [1]
0
0
Side Effects
Query!
Assessment method [1]
0
0
Collating common side effects on treatment
Query!
Timepoint [1]
0
0
3-6 months
Query!
Secondary outcome [2]
0
0
Rapid Virological Response (RVR) by HCV RNA PCR
Query!
Assessment method [2]
0
0
Viral load 4 weeks after starting treatment as measured by HCV RNA PCR
Query!
Timepoint [2]
0
0
4 weeks
Query!
Secondary outcome [3]
0
0
End Of Treatment (EOT) Response by HCV RNA PCR
Query!
Assessment method [3]
0
0
Viral load at end of treatment as measured by HCV RNA PCR
Query!
Timepoint [3]
0
0
3-6 months
Query!
Secondary outcome [4]
0
0
Sustained Virological Response (SVR12) by HCV RNA PCR
Query!
Assessment method [4]
0
0
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)
Query!
Timepoint [4]
0
0
6-12 months
Query!
Eligibility
Key inclusion criteria
Quantitative HCV RNA > 100
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
82
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Contraindications to DAA medications
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/06/2018
Query!
Actual
Query!
Sample size
Target
10000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
TAS
Query!
Recruitment hospital [1]
0
0
FixHepC - Hobart
Query!
Recruitment postcode(s) [1]
0
0
7004 - Hobart
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
FixHepC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02657694
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
James Freeman, MB,BS,BSc
Query!
Address
0
0
ACRRM
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02657694