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Alphanate in Immune Tolerance Induction Therapy

NCT03095287 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-11-23

Study results available
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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.

Conditions

  • Hemophilia A, Congenital

Interventions

BIOLOGICAL

Alphanate

Bolus IV injection.

Sponsors & Collaborators

  • Grifols Biologicals, LLC

    collaborator INDUSTRY

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2020-09-18
Completion
2020-09-18
FDA Drug
Yes

Countries

  • United States
  • Canada
  • India
  • Italy
  • Russia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095287 on ClinicalTrials.gov