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Recombinant Factor VIII

efanesoctocog alfa (BIVV001) for Von Willebrand Disease

Phase 1
Waitlist Available
Research Sponsored by Bioverativ, a Sanofi company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 10
Awards & highlights

Study Summary

This trial is to test a new medication for people with von Willebrand Disease, specifically to see how well it works and if it is safe.

Eligible Conditions
  • Von Willebrand Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic Parameter: Area under the activity time curve extrapolated to infinity (AUC∞)
Pharmacokinetic Parameter: Incremental recovery (IR)
Pharmacokinetic Parameter: Maximum plasma concentration observed (Cmax)
+4 more
Secondary outcome measures
Number of participants with adverse events

Side effects data

From 2022 Phase 3 trial • 159 Patients • NCT04161495
20%
Headache
19%
Arthralgia
8%
Fall
6%
Back Pain
5%
Fatigue
2%
Haemophilic Arthropathy
1%
Cd4 Lymphocytes Decreased
1%
Mobility Decreased
1%
Ulnar Tunnel Syndrome
1%
Basal Cell Carcinoma
1%
Combined Tibia-Fibula Fracture
1%
Arthropathy
1%
Blood Glucose Increased
1%
Cubital Tunnel Syndrome
1%
Status Epilepticus
1%
Angina Pectoris
1%
Traumatic Haemorrhage
1%
Central Venous Catheter Removal
1%
Device Breakage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Prophylaxis
Arm B: On-demand
Arm B: Prophylaxis
BIVV001 (Efanesoctocog Alfa): All Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: efanesoctocog alfa (BIVV001)Experimental Treatment1 Intervention
A single IV dose of BIVV001 will be administered to each patient
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efanesoctocog alfa (BIVV001)
2021
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Bioverativ, a Sanofi companyLead Sponsor
17 Previous Clinical Trials
1,030 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,293 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my eligibility conforming to the requirements of this clinical experiment?

"To be accepted into this research, participants must have a confirmed diagnosis of von willebrand disease and meet the age criteria (18-65). This trial is hoping to include 9 individuals in total."

Answered by AI

Are there any vacancies available for individuals to partake in this medical trial?

"Affirmative, the details displayed on clinicaltrials.gov indicate that this medical experiment is currently gathering participants. This trial was initially published on May 3rd 2021 and last modified on June 30th 2022, with a total of 9 patients sought from 4 separate sites."

Answered by AI

Could individuals younger than seventy-five years old potentially partake in this medical investigation?

"This trial is open to participants aged 18-65, though there are 10 trials that cater to those under 18 and 9 for people over the age of 65."

Answered by AI

Has efanesoctocog alfa (BIVV001) been sanctioned by the Food and Drug Administration?

"Despite its limited clinical data, efanesoctocog alfa (BIVV001) was still given a score of 1. This is because it's in Phase 1 and only has preliminary safety and efficacy evidence."

Answered by AI

Is this study pioneering a new methodology in its field?

"Initial research of efanesoctocog alfa (BIVV001) began in 2021, with the first clinical trial sponsored by Bioverativ, a business owned by Sanofi. After successful results from 75 patients during Phase 1 trials, this drug eventually earned its approval for use as an approved medication. In present day, there are 3 active studies on efanesoctocog alfa (BIVV001), spanning 41 cities and 23 countries worldwide."

Answered by AI

What is the aggregate amount of individuals taking part in this experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour was initially posted on May 3rd 2021 and is currently recruiting participants. A total of 9 individuals must be enrolled from 4 distinct medical sites."

Answered by AI

Are there any records of prior experimentation with efanesoctocog alfa (BIVV001)?

"Currently, 3 clinical tests are being conducted to evaluate the efficacy of efanesoctocog alfa (BIVV001). Two of them have advanced to Phase 3. The primary site for these trials is Leuven in Illinois, but there are 171 sites across America running related studies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
2021. "To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770935.
~2 spots leftby Apr 2025
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