← Back to Search

Coagulation Factor Replacement Therapy

BAX 888 for Hemophilia A

Phase 1 & 2
Waitlist Available
Research Sponsored by Baxalta now part of Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male, aged 18 to 75 years at the time of screening
Established severe hemophilia A (FVIII:C <1%, measured following >=5 days without FVIII treatment) and/or documented intron 1 inversion or intron 22 inversion mutation in the F8 gene, consistent with severe hemophilia A, and documented evidence of >=3 hemorrhages over the previous 12 months requiring treatment with exogenous FVIII or use of FVIII prophylaxis because of history of frequent bleeding episodes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 2 consecutive measurements are negative or up to 5 years, whichever is sooner
Awards & highlights

Study Summary

This trial is testing a new medication for hemophilia A to see if there are any side effects and to find the right dose.

Who is the study for?
This trial is for male adults aged 18-75 with severe hemophilia A, who have had more than 150 exposure days to FVIII treatments and at least three bleeding episodes in the past year. Participants must be willing to use barrier contraception and comply with study requirements like providing semen samples and keeping a diary of bleeding episodes.Check my eligibility
What is being tested?
The trial is testing BAX 888's safety and determining its proper dose for treating severe hemophilia A. Participants will receive one infusion of BAX 888 at a treatment center and make multiple visits to their study clinic for monitoring.See study design
What are the potential side effects?
While specific side effects are not listed, the trial aims to identify any adverse reactions from BAX 888 during the dosage determination process. Side effects could range from mild injection site reactions to more significant systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man between 18 and 75 years old.
Select...
I have severe hemophilia A with frequent bleeding episodes.
Select...
I have been treated with blood clotting factor concentrates or cryoprecipitate for more than 150 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 2 consecutive measurements are negative or up to 5 years, whichever is sooner
This trial's timeline: 3 weeks for screening, Varies for treatment, and until 2 consecutive measurements are negative or up to 5 years, whichever is sooner for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With BAX 888-Related Adverse Events (AEs)
Secondary outcome measures
Annualized Bleed Rate (ABR)
Change from Baseline in Circulating Plasma FVIII Activity Level
Change from Baseline in Circulating Plasma FVIII Antigen Level
+5 more

Side effects data

From 2015 Phase 4 trial • 303 Patients • NCT01064284
17%
Pyrexia
12%
Nasopharyngitis
8%
Cough
8%
Upper respiratory tract infection
6%
Viral infection
6%
Vomiting
5%
Diarrhoea
5%
Bronchitis
3%
Anaemia
2%
Head Injury
2%
Subcutaneous haematoma
2%
Pharyngitis
1%
Haemorrhage
1%
Haemorrhagic anaemia
1%
Nausea
1%
Haematemesis
1%
Haemorrhage intracranial
1%
Hemiparesis
1%
Hemiplegia
1%
Hypersomnia
1%
Lymphadenopathy
1%
Pancytopenia
1%
Road traffic accident
1%
Seizure
1%
Skin haemorrhage
1%
Speech disorder developmental
1%
Urinary tract infection
1%
Vessel puncture site haemorrhage
1%
Haemarthrosis
1%
Muscle haemorrhage
1%
Subdural haematoma
1%
Abdominal wall haemorrhage
1%
Cerebral haemorrhage
1%
Circumcision
1%
Epidural Haemorrage
100%
80%
60%
40%
20%
0%
Study treatment Arm
pd vWF/FVIII
rFVIII

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Cohort 3 participants will receive a single peripheral IV infusion of BAX 888 at a dose of 1.2*10^13 cp/kg on the day of dosing (Day 0).
Group II: Cohort 2Experimental Treatment1 Intervention
Cohort 2 participants will receive a single peripheral IV infusion of BAX 888 at a dose of 6.0*10^12 cp/kg on the day of dosing (Day 0).
Group III: Cohort 1Experimental Treatment1 Intervention
Cohort 1 participants will receive a single peripheral intravenous (IV) infusion of BAX 888 at a dose of 2.0*10^12 capsid particles per kilogram (cp/kg) on the day of dosing (Day 0).

Find a Location

Who is running the clinical trial?

Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
9,083 Total Patients Enrolled
52 Trials studying Hemophilia A
4,020 Patients Enrolled for Hemophilia A
Baxalta Innovations GmbH, now part of ShireIndustry Sponsor
18 Previous Clinical Trials
7,999 Total Patients Enrolled
9 Trials studying Hemophilia A
1,574 Patients Enrolled for Hemophilia A
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,191 Total Patients Enrolled
2 Trials studying Hemophilia A
170 Patients Enrolled for Hemophilia A

Media Library

Hemophilia A Clinical Trial 2023: BAX 888 Highlights & Side Effects. Trial Name: NCT03370172 — Phase 1 & 2

Frequently Asked Questions

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

Is this a previously unexplored research endeavor?

"Grifols Biologicals, LLC has sponsored a total of 4 BAX 888 trials since 2007. Across 19 nations and 41 cities, these studies have concluded Phase 4 drug approval with 15 participants each on average. In the 13 years that followed, 26 more clinical studies were carried out to their completion."

Answered by AI

Is this research in search of participants?

"Unfortunately, this medical investigation is not presently accepting individuals. Initially posted on March 31st 2018 and revised November 23rd 2021, it has since been suspended from recruitment. If you are seeking other trials, 89 clinical studies for hemophilia A and 4 for BAX 888 currently remain open to new participants."

Answered by AI

What is the current size of the cohort enrolled in this experiment?

"Recruitment for this trial has concluded. It was initially posted on March 31st 2018 and last modified on November 23rd 2021. There are currently 89 clinical trials in search of participants with hemophilia a, as well as 4 studies recruiting patients to test BAX 888."

Answered by AI

Is eligibility for the trial open to individuals aged 45 and above?

"This trial is open to individuals between 18 and 75 years old."

Answered by AI

Do I meet the qualifications to partake in this medical experiment?

"In order to be accepted into this trial, participants must have been diagnosed with hemophilia A and within the age range of 18-75 years old. At present, 12 volunteers are being sought after for the research."

Answered by AI

What therapeutic effects does BAX 888 typically bring about?

"BAX 888 is a commonly used medication for treating bleeding. It can be equally effective in managing von willebrand disease, motor neuron disorder, and desmopressin-related issues."

Answered by AI

Are there other investigations that have explored the efficacy of BAX 888?

"Currently, there are 4 ongoing BAX 888 studies. Of these trials, two have reached the third phase of clinical testing. The majority of investigations for this treatment is located in Paris, Maryland; however, research has extended to 84 other sites worldwide."

Answered by AI

Are there numerous health care centers in North America who are active participants in this medical study?

"The University of Colorado Hemophilia & Thrombosis Center in Aurora, California is the primary site for this medical trial. Additionally, Orthopaedic Hemophilia Treatment Centre located in Los Angeles and Gulf States Hemophilia and Thrombology Centre situated Houston are involved with 6 other participating centres nationwide."

Answered by AI
~3 spots leftby Apr 2025