Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)
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ClinicalTrials.gov Identifier: NCT02657694 |
Recruitment Status : Unknown
Verified February 2017 by FixHepC.
Recruitment status was: Enrolling by invitation
First Posted : January 18, 2016
Last Update Posted : February 16, 2017
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Condition or disease | Intervention/treatment |
---|---|
Hepatitis C | Drug: Sofosbuvir+Ledipasvir Drug: Sofosbuvir+Daclatasvir Drug: Sofosbuvir+Velpatasvir |
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 Type : | Observational [Patient Registry] |
Estimated Enrollment : | 10000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods |
Actual Study Start Date : | July 1, 2015 |
Actual Primary Completion Date : | January 1, 2017 |
Estimated Study Completion Date : | June 30, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Sofosbuvir+Ledipasvir
Following patients treating with Sofosbuvir+Ledipasvir
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Drug: Sofosbuvir+Ledipasvir
DAA medication treatment
Other Name: Harvoni (generic) |
Sofosbuvir+Daclatasvir
Following patients treating with Sofosbuvir+Daclatasvir
|
Drug: Sofosbuvir+Daclatasvir
DAA medication treatment
Other Names:
|
Sofosbuvir+Velpatasvir
Following patients treating with Sofosbuvir+Velpatasvir
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Drug: Sofosbuvir+Velpatasvir
DAA medication treatment
Other Name: Epclusa (generic) |
- 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)
- Side Effects [ Time Frame: 3-6 months ]Collating common side effects on treatment
- Rapid Virological Response (RVR) by HCV RNA PCR [ Time Frame: 4 weeks ]Viral load 4 weeks after starting treatment as measured by HCV RNA PCR
- End Of Treatment (EOT) Response by HCV RNA PCR [ Time Frame: 3-6 months ]Viral load at end of treatment as measured by HCV RNA PCR
- Sustained Virological Response (SVR12) by HCV RNA PCR [ Time Frame: 6-12 months ]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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Ages Eligible for Study: | 18 Years to 82 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Quantitative HCV RNA > 100
Exclusion Criteria:
Contraindications to DAA medications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657694
Australia, Tasmania | |
FixHepC | |
Hobart, Tasmania, Australia, 7004 |
Study Director: | James Freeman, MB,BS,BSc | ACRRM |
Responsible Party: | FixHepC |
ClinicalTrials.gov Identifier: | NCT02657694 |
Other Study ID Numbers: |
REDEMPTION |
First Posted: | January 18, 2016 Key Record Dates |
Last Update Posted: | February 16, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections Communicable Diseases Infections Hepatitis, Viral, Human Virus Diseases |
Flaviviridae Infections RNA Virus Infections Sofosbuvir Sofosbuvir-velpatasvir drug combination Ledipasvir Velpatasvir Antiviral Agents Anti-Infective Agents |