CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 73 enrolled
Drug / intervention
Emicizumabdrug
Likely dose
Emicizumab 3 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04158648
NCT04158648Phase 3Completed
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A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors

Hoffmann-La Roche·interventional·Posted Nov 12, 2019·Updated Jan 23, 2026

In Brief

A Phase 3 clinical trial evaluating Emicizumab for Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor and 2 related conditions. Completed, enrolled 73 participants across 22 sites in 10 countries.

Detailed Summary

This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor, Hemophilia A
CountriesBelgium, Canada, France, Germany, Netherlands, Poland, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 12, 2019
Enrollment StartFeb 10, 2020
Primary CompletionOct 30, 2021
Study CompletionDec 19, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.6 years ago

Interventions

Emicizumabdrug

Four loading doses of emicizumab 3 milligrams per kilogram of body weight (mg/kg) will be administered subcutaneously (SC) once a week (QW) for 4 weeks followed by participant's preference of one of the three following maintenance SC dose regimens: 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W).