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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02657694
First Posted: January 18, 2016
Last Update Posted: February 16, 2017
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
FixHepC
  Purpose
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 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

Resource links provided by NLM:


Further study details as provided by FixHepC:

Primary Outcome Measures:
  • 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:
  • 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:
  • Sovaldi (generic)
  • Daklinza (generic)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Study Population
Worldwide, Hepatitis C Genotypes 1-6
Criteria

Inclusion Criteria:

Quantitative HCV RNA > 100

Exclusion Criteria:

Contraindications to DAA medications

  Contacts and Locations
Information from the National Library of Medicine

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


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     History of Changes
Other Study ID Numbers: REDEMPTION
First Submitted: January 14, 2016
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, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Sofosbuvir
Ledipasvir
Antiviral Agents
Anti-Infective Agents