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NCT02613910 · ClinicalTrials.gov registry record · Phase 3
Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT02613910: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT02613910 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613910, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study is designed as a multi-country, multicenter, open label extension to Phase III trial OPV116910. The primary objective is to provide continued treatment with ofatumumab subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain further long term safety and tolerability information in subjects with pemphigus vulgaris receiving ofatumumab SC every 4 weeks (wk).
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled.
Interventions
- DRUG Acetaminophen/paracetamol
- DRUG Prednisone/Prednisolone
- DRUG Ofatumumab
- DRUG Antihistamine (cetirizine or equivalent)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2016-03-23 |
| Phase | Phase 3 |
Why NCT02613910 stopped before completion
NCT02613910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Acetaminophen/paracetamol is the first listed.
NCT02613910 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02613910 about?
NCT02613910 is a clinical study titled "Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris". This study is designed as a multi-country, multicenter, open label extension to Phase III trial OPV116910. The primary objective is to provide continued treatment with ofatumumab subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain further long term safety and ...
What is the current status of trial NCT02613910?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2015-12-23. Estimated completion is 2016-03-23.
What interventions are being tested in trial NCT02613910?
The interventions under investigation include: Acetaminophen/paracetamol (DRUG), Prednisone/Prednisolone (DRUG), Ofatumumab (DRUG), Antihistamine (cetirizine or equivalent) (DRUG).
Who is sponsoring clinical trial NCT02613910?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613910's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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