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NCT03095287 · ClinicalTrials.gov registry record · Phase 2
Alphanate in Immune Tolerance Induction Therapy
A Phase 2 study, sponsored by Grifols Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03095287: Clinical Trial Phase 2 study, sponsored by Grifols Therapeutics.
NCT03095287 is a Phase 2 study that was terminated before completion, run by Grifols Therapeutics. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095287, a Phase 2 study, was terminated before completion, sponsored by Grifols Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate. The study consists of 2 phases: * An ITI Treatment Phase in which all eligible participants will receive ITI treatment with alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, participants will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a participants has achieved partial immune tolerance, the participants will enter a 12-month Prophylactic Phase. * A 12-month Prophylactic Phase for all participants who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of alphanate. Due to limited enrollment, this study was early terminated.
Primary Outcome
Complete immune tolerance was defined as the participants achieving 2 consecutive undetectable inhibitor titers (\<0.6 BU) performed within 2 weeks of each other, Factor VIII activity (FVIII:C) in vivo plasma recovery ≥66% of the predicted normal value and FVIII:C half-life ≥6 hours after a 72-hour FVIII treatment-free period.
Interventions
- BIOLOGICAL Alphanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2020-09-18 |
| Phase | Phase 2 |
Why NCT03095287 stopped before completion
NCT03095287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Alphanate is the first listed.
NCT03095287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03095287 about?
NCT03095287 is a clinical study titled "Alphanate in Immune Tolerance Induction Therapy". This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate. The study consists of 2 pha...
What is the current status of trial NCT03095287?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2018-01-03. Estimated completion is 2020-09-18.
What interventions are being tested in trial NCT03095287?
The interventions under investigation include: Alphanate (BIOLOGICAL).
Who is sponsoring clinical trial NCT03095287?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03095287's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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