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NCT03073967 · ClinicalTrials.gov registry record · Phase 3
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
A Phase 3 study, sponsored by AiCuris Anti-infective Cures.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT03073967 is a Phase 3 study that has completed, run by AiCuris Anti-infective Cures. The registered enrollment target is 158 participants.
The verdict
NCT03073967, a Phase 3 study, has completed, sponsored by AiCuris Anti-infective Cures.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
Study Summary
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).
Interventions
- DRUG Pritelivir
- DRUG Investigator's choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2025-11-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03073967
The ClinicalTrials.gov registry entry for NCT03073967 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AiCuris Anti-infective Cures, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pritelivir is the first listed.
NCT03073967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03073967 about?
NCT03073967 is a clinical study titled "Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects". Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidl...
What is the current status of trial NCT03073967?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2017-05-08. Estimated completion is 2025-11-11.
What interventions are being tested in trial NCT03073967?
The interventions under investigation include: Pritelivir (DRUG), Investigator's choice (DRUG).
Who is sponsoring clinical trial NCT03073967?
This trial is sponsored by AiCuris Anti-infective Cures, which has 6 total clinical trials registered on ClinicalTrials.gov.
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