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NCT03235154 · ClinicalTrials.gov registry record · Phase 4
A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic
A Phase 4 study, sponsored by Community Research Initiative of New England.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03235154: Completed Phase 4 study, sponsored by Community Research Initiative of New England.
NCT03235154 is a Phase 4 study that has completed, run by Community Research Initiative of New England. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03235154, a Phase 4 study, has completed, sponsored by Community Research Initiative of New England.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
The main purpose of this pilot study is to investigate the safety, effectiveness and tolerability of the study medication in the treatment of people with chronic hepatitis C virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction treatment.
Primary Outcome
To assess the effectiveness of HCV treatment with velpatasvir/sofosbuvir administered by psychiatrist/licensed buprenorphine/naloxone providers during regularly scheduled visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental healthcare, as measured by percentage of patients achieving SVR-12 (defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of study treatment),
Interventions
- DRUG sofosbuvir/velpatasvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 4 |
What the finished NCT03235154 record still lists
NCT03235154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which sofosbuvir/velpatasvir is the first listed.
NCT03235154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03235154 about?
NCT03235154 is a clinical study titled "A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic". The main purpose of this pilot study is to investigate the safety, effectiveness and tolerability of the study medication in the treatment of people with chronic hepatitis C virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction treatment.
What is the current status of trial NCT03235154?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2017-10-11. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT03235154?
The interventions under investigation include: sofosbuvir/velpatasvir (DRUG).
Who is sponsoring clinical trial NCT03235154?
This trial is sponsored by Community Research Initiative of New England, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03235154's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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