Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
| Condition | Intervention |
|---|---|
| Hepatitis C | Drug: Sofosbuvir+Ledipasvir Drug: Sofosbuvir+Daclatasvir Drug: Sofosbuvir+Velpatasvir |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods |
- 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)
| Estimated Enrollment: | 10000 |
| Actual Study Start Date: | July 1, 2015 |
| Estimated Study Completion Date: | June 30, 2018 |
| Primary Completion Date: | January 1, 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Sofosbuvir+Ledipasvir
Following patients treating with Sofosbuvir+Ledipasvir
|
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
|
Drug: Sofosbuvir+Velpatasvir
DAA medication treatment
Other Name: Epclusa (generic)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 82 Years (Adult, Senior) |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02657694
| Australia, Tasmania | |
| FixHepC | |
| Hobart, Tasmania, Australia, 7004 | |
| Study Director: | James Freeman, MB,BS,BSc | ACRRM |
More Information
Additional Information:
| Responsible Party: | FixHepC |
| ClinicalTrials.gov Identifier: | NCT02657694 History of Changes |
| Other Study ID Numbers: |
REDEMPTION |
| Study First Received: | January 14, 2016 |
| Last Updated: | February 14, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis |
Liver Diseases Digestive System Diseases Sofosbuvir Ledipasvir Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 14, 2017


IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
