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NCT02753699 · ClinicalTrials.gov registry record · Phase 3
Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients
A Phase 3 study of Hepatitis C, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 3
- Development phase
- 723
- Enrollment target
- 20
- Study locations
NCT02753699 is a Phase 3 study of Hepatitis C that has completed, run by Debiopharm International. The registered enrollment target is 723 participants, below the 1,883-participant average among 106 other Hepatitis C trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT02753699, a Phase 3 study of Hepatitis C, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 723 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time. Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.
Conditions Studied
Interventions
- DRUG Alisporivir
Study Locations (20)
Texas
- Novartis Investigative Site - Arlington
- Novartis Investigative Site - Dallas
- Novartis Investigative Site - Houston
- Novartis Investigative Site - San Antonio
California
- Novartis Investigative Site - La Jolla
- Novartis Investigative Site - San Diego
- Novartis Investigative Site - Ventura
New South Wales
- Novartis Investigative Site - Kingswood
- Novartis Investigative Site - Kogarah
- Novartis Investigative Site - Westmead
Buenos Aires
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - Buenos Aires
Florida
- Novartis Investigative Site - Bradenton
Hawaii
- Novartis Investigative Site - Honolulu
Illinois
- Novartis Investigative Site - Springfield
Indiana
- Novartis Investigative Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 723 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02753699
The ClinicalTrials.gov registry entry for NCT02753699 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 723 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,883-participant average among 106 other Hepatitis C trials with a reported enrollment target (62% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 1 intervention - of which Alisporivir is the first listed.
NCT02753699 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, New South Wales.
Frequently Asked Questions
What is clinical trial NCT02753699 about?
NCT02753699 is a clinical study titled "Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients". The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment saf...
What is the current status of trial NCT02753699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 723 participants. The study started on 2011-12. Estimated completion is 2015-05.
What conditions does trial NCT02753699 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT02753699?
The interventions under investigation include: Alisporivir (DRUG).
Who is sponsoring clinical trial NCT02753699?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02753699 being conducted?
This trial has 20 study locations across California, Florida, Hawaii, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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