Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)

• ClinicalTrials.gov Identifier: NCT02657694
• Recruitment Status: Unknown
• First Posted: January 18, 2016
• Last Update Posted: February 16, 2017
• Sponsor: FixHepC
• Information provided by (Responsible Party): FixHepC

Study Description

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.

Condition or disease	Intervention/treatment
Hepatitis C	Drug: Sofosbuvir+Ledipasvir; Drug: Sofosbuvir+Daclatasvir; Drug: Sofosbuvir+Velpatasvir

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

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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: Sovaldi (generic); Daklinza (generic)
Sofosbuvir+Velpatasvir; Following patients treating with Sofosbuvir+Velpatasvir	Drug: Sofosbuvir+Velpatasvir; DAA medication treatment; Other Name: Epclusa (generic)

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. Side Effects [ Time Frame: 3-6 months ]
   Collating common side effects on treatment
2. 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
3. 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
4. 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)

Eligibility Criteria

• 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

Study Population

Worldwide, Hepatitis C Genotypes 1-6

Criteria

Inclusion Criteria:

Quantitative HCV RNA > 100

Exclusion Criteria:

Contraindications to DAA medications

Contacts and Locations

Locations

Australia, Tasmania

FixHepC

Hobart, Tasmania, Australia, 7004

Sponsors and Collaborators

FixHepC

Investigators

• Study Director: James Freeman, MB,BS,BSc; ACRRM

More Information

Additional Information:

• Responsible Party: FixHepC
• ClinicalTrials.gov Identifier: NCT02657694
• Other Study ID Numbers: REDEMPTION
• First Posted: January 18, 2016
• Last Update Posted: February 16, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Additional relevant MeSH terms:

Hepatitis C; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Sofosbuvir; Ledipasvir; Velpatasvir; Antiviral Agents; Anti-Infective Agents