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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 is a Phase 2 study that was terminated before completion, run by Grifols Therapeutics. The registered enrollment target is 2 participants.
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.
Interventions
- BIOLOGICAL Alphanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2020-09-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095287
The ClinicalTrials.gov registry entry for NCT03095287 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alphanate is the first listed.
NCT03095287 reports 0 study locations.
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.
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