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NCT03913195 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
A Phase 3 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT03913195: Completed Phase 3 study, sponsored by TaiMed Biologics.
NCT03913195 is a Phase 3 study that has completed, run by TaiMed Biologics. The registered enrollment target is 43 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913195, a Phase 3 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push" or intramuscular injection. An initial "Sentinel Group" of 5 participants will begin receiving 800mg Trogarzo on a gradual schedule of increasing concentration and decreasing administration time until undiluted IV Push over 30 seconds is achieved, while safety and pharmacokinetics are evaluated. If no safety signals are seen, the Core Group of 15 participants will be enrolled. The Core Group will receive 800mg Trogarzo via undiluted IV Push over 30 seconds while safety and pharmacokinetics are monitored. After completion of the IV Push portion of the study, a second group of 20 participants will be enrolled to evaluate the safety and pharmacokinetics of administration of 800mg via intramuscular injection.
Primary Outcome
Number of subjects who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Interventions
- DRUG ibalizumab-uiyk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 3 |
What the finished NCT03913195 record still lists
NCT03913195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which ibalizumab-uiyk is the first listed.
NCT03913195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03913195 about?
NCT03913195 is a clinical study titled "Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection". This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push" or intramuscular injection. An initial "Sentinel Group" of 5 participants will begin receiving 800mg Trogarzo on a gradual schedule of increasing concentration a...
What is the current status of trial NCT03913195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2019-05-30. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT03913195?
The interventions under investigation include: ibalizumab-uiyk (DRUG).
Who is sponsoring clinical trial NCT03913195?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913195's enrollment target sits among peer trials
43 1876th of 2000 higher than 124 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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