Hepatitis CREDEMPTIONNCT02657694
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
An observational study of Hepatitis C, run by FixHepC at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir+Ledipasvir, Sofosbuvir+Daclatasvir and Sofosbuvir+Velpatasvir
- How many people
- 10,000 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2015to 30 Jun 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Worldwide, Hepatitis C Genotypes 1-6
Who may be able to join
- Quantitative HCV RNA > 100
Who cannot join
- Contraindications to DAA medications
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir+Ledipasvir, Sofosbuvir+Daclatasvir, Sofosbuvir+Velpatasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir+LedipasvirDrug
Also called Harvoni (generic)
DAA medication treatment
Sofosbuvir+DaclatasvirDrug
Also called Sovaldi (generic), Daklinza (generic)
DAA medication treatment
Sofosbuvir+VelpatasvirDrug
Also called Epclusa (generic)
DAA medication treatment
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir+Ledipasvir | Following patients treating with Sofosbuvir+Ledipasvir Receives: Drug: Sofosbuvir+Ledipasvir | |
| Sofosbuvir+Daclatasvir | Following patients treating with Sofosbuvir+Daclatasvir Receives: Drug: Sofosbuvir+Daclatasvir | |
| Sofosbuvir+Velpatasvir | Following patients treating with Sofosbuvir+Velpatasvir Receives: Drug: Sofosbuvir+Velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4-7 months
Secondary outcomes (4)
Side Effects
Collating common side effects on treatment
Measured: 3-6 months
Rapid Virological Response (RVR) by HCV RNA PCR
Viral load 4 weeks after starting treatment as measured by HCV RNA PCR
Measured: 4 weeks
End Of Treatment (EOT) Response by HCV RNA PCR
Viral load at end of treatment as measured by HCV RNA PCR
Measured: 3-6 months
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)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start1 Jul 2015
- Primary completion1 Jan 2017
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- FixHepC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Freeman, MB,BS,BSc, Study director, ACRRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657694
- Sponsor's protocol ID
- REDEMPTION
- Acronym
- REDEMPTION
- Status last verified
- Feb 2017
- First submitted
- 14 Jan 2016
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
- ClinicalTrials.gov ID
- NCT02657694
- Acronym / sponsor ID
- REDEMPTION / REDEMPTION
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- FixHepCUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir+Ledipasvir | – | Drug: Sofosbuvir+LedipasvirFollowing patients treating with Sofosbuvir+Ledipasvir |
| Sofosbuvir+Daclatasvir | – | Drug: Sofosbuvir+DaclatasvirFollowing patients treating with Sofosbuvir+Daclatasvir |
| Sofosbuvir+Velpatasvir | – | Drug: Sofosbuvir+VelpatasvirFollowing patients treating with Sofosbuvir+Velpatasvir |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Worldwide, Hepatitis C Genotypes 1-6
Key inclusion criteria (1 listed)
- Quantitative HCV RNA > 100
Key exclusion criteria (1 listed)
- Contraindications to DAA medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir+LedipasvirAlso: Harvoni (generic)DAA medication treatment | Drug | Sofosbuvir+Ledipasvir |
| Sofosbuvir+DaclatasvirAlso: Sovaldi (generic), Daklinza (generic)DAA medication treatment | Drug | Sofosbuvir+Daclatasvir |
| Sofosbuvir+VelpatasvirAlso: Epclusa (generic)DAA medication treatment | Drug | Sofosbuvir+Velpatasvir |
Primary outcome
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 secondary outcomes
Side Effects
Time frame: 3-6 months
Rapid Virological Response (RVR) by HCV RNA PCR
Time frame: 4 weeks
End Of Treatment (EOT) Response by HCV RNA PCR
Time frame: 3-6 months
Sustained Virological Response (SVR12) by HCV RNA PCR
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- REDEMPTION WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Freeman, MB,BS,BSc study director
ACRRM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by FixHepC at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR) (time frame: 4-7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.