Sponsor study identifier
interventional
420
1 country
1
Study Start
February 2015
Actual (reported)Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will investigate the feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a social network-based approach to reduce HCV incidence among PWID.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2014
Actual (reported)February 2015
Actual (reported)February 16, 2015
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The efficacy of treating PWID with HCV using 12 weeks of oral therapy via a community-based, nurse-led treatment model, as measured by SVR rates
Change in sustained viral response rates at weeks 12 and 24 post-treatment. Participant retention rate at weeks 4, 8 and 12 (end of treatment).
The effectiveness of treating PWID on rates of HCV primary infection and reinfection among their social networks, as measured by HCV incidence rates among primary and secondary participants
Hypothesis: Offering HCV treatment to PWID will lead to a lower incidence of transmission of HCV from primary participants to their injecting partners, compared to not treating any PWID.
Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
The effectiveness of treating PWID using a "bring your friends" strategy on rates of HCV primary infection and reinfection, as measured by HCV incidence rates among participants
Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
Changes in levels of injecting risk behaviours among participants following HCV treatment, as measured by self-reported frequency of risky injecting behaviours among participants
Weeks 12, 24, 36, 48, 60, 72 and 84
Changes to Quality of Life (QoL) among treated participants versus non-treated participants, as measured by self-reported responses to validated QoL scales
Weeks 12, 24, 36, 48, 60, 72 and 84
The prevalence of HCV resistance associated variants among treated participants who do not achieve SVR12
At 12 weeks post-treatment (SVR12) and weeks 24 (SVR24), 36, 48, 60 and 72 post-treatment
Changes in the level of transient liver elastography readings (measured using Fibroscan®) among treated participants versus non-treated participants
Up to 84 weeks
Primary (n=40) and secondary (n=100) participants will receive supportive care only (includes a clinical review, questionnaire and blood sample collected at baseline and weeks 12, 24, 36, 48, 60, 72 and 84). Participants with HCV not allocated to treatment arms will receive deferred treatment at the end of the follow-up period.
Primary participants (n=40) will be treated with 'Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP) for 12 weeks. Secondary participants (n=100) will receive supportive care only. Participants with HCV not allocated to treatment arms will receive deferred treatment at the end of the follow-up period.
SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordBurnet Institute
Melbourne, Victoria, 3004, Australia
Prof Margaret Hellard
Burnet Institute
Prof Alexander Thompson
St Vincent's Hospital Melbourne
First Submitted
December 21, 2014
First Posted
February 16, 2015
Study Start
February 2015
Actual (reported)Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The feasibility of treating PWID with HCV using 12 weeks of oral therapy via a community-based, nurse-led treatment model, as measured by SVR rates and participant retention
Change in participant retention rates at weeks 4, 8 and 12 (end of treatment)
Primary (n=40) and secondary participants with chronic HCV infection (approx. n=50%\*100) will be treated with 'Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP) for 12 weeks. Participants in Group C who have evidence of HCV re-infection will be offered re-treatment with SOF + LDP for 12 weeks.
Contact the study team to confirm eligibility.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 10, 2018
Record last verified: 2018-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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