MinorEligibility criteria expanded, about 259 words
Site details revised at 19 of 63 sites
NotablePrimary endpoints: details revised at 1 of 8 entries
Study sites: 64 to 63
Eligibility criteria expanded, about 29 words
Secondary endpoints: details revised at 1 of 10 entries
MinorTrial sites expanded: 34 → 64 locationsv35
MinorTrial sites reduced: 66 → 34 locationsv34
MinorStudy sites: 60 to 66v33
Show 31 earlier versionsHide 31 earlier versions
MinorStudy sites: 69 to 60v32
MinorStudy sites: 72 to 69v31
MinorSite details revised at 1 of 72 sitesv30
MinorStudy sites: 69 to 72v29
MinorStudy sites: 65 to 69v28
MinorStudy sites: 63 to 65
Eligibility criteria expanded, about 4 words
v27
MinorStudy sites: 62 to 63v26
MinorStudy sites: 61 to 62v25
MinorStudy sites: 59 to 61v24
MinorStudy sites: 58 to 59
Eligibility criteria expanded, about 58 words
v23
MinorStudy sites: 53 to 58v22
MinorStudy sites: 44 to 53v21
MinorStudy sites: 39 to 44v20
MinorStudy sites: 36 to 39v19
MinorSite details revised at 1 of 36 sitesv18
MinorStudy sites: 34 to 36v17
MinorStudy sites: 33 to 34v16
MinorStudy sites: 32 to 33v15
MinorStudy sites: 29 to 32v14
MinorStudy sites: 20 to 29v13
MinorStudy sites: 19 to 20
Eligibility criteria expanded, about 26 words
v12
MinorStudy sites: 17 to 19v11
MinorStudy sites: 14 to 17v10
MinorStudy sites: 13 to 14v9
MinorStudy sites: 12 to 13v8
MinorStudy sites: 6 to 12v7
MinorStudy sites: 4 to 6v6
MinorStudy sites: 3 to 4v5
MinorStudy sites: 2 to 3v4
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 2
Start date changed from estimate of Dec 5, 2022 to Dec 9, 2022
v3
MinorStart date: Nov 15, 2022 to Dec 5, 2022v2
Study First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called marstacimab) for the potential treatment of hemophilia in pediatric patients.
This study will enroll pediatric participants from ages 1 to 17 years in a sequential manner. The study opened the enrollment to adolescent participants aged 12 to 17 years first. Then children aged 6 to 11 years erere permitted to enroll. Lastly, children aged 1 to 5 years are permitted to enroll.
This study will enroll male participants who:
* have severe Hemophilia A or moderately severe to severe Hemophilia B (with or without inhibitors)
* have accurate historical records documenting all factor VIII, factor IX, or bypass agent infusions and hemophilia bleed events for at least 1 year prior to entering the study for participants from 6 to 17 years of age, and at least 3 months prior to entering the study for participants from 1 to 5 years of age
* if a non-inhibitor patient, must be on a stable routine prophylaxis regimen with factor VIII or factor IX replacement products for at least 12 months prior to study entry for participants from 6 to 17 years of age, and least 3 months for participants aged from 1 to 5 years of age
* if an inhibitor patient, must be on an on-demand bypass treatment regimen during the 12 months prior to study entry for participants from 6 to 17 years of age, and during the 3 months prior to study entry for participants aged from 1 to 5 years of age
All participants in this study will receive marstacimab to use prophylactically. Marstacimab will be given once a week as a subcutaneous (under the skin) shot. The first dose of marstacimab will be given at the study site by the study site staff. During the 12-month treatment period, weekly doses of marstacimab can be given at home, or if preferred, the doses may be given by the study site staff.
To help us determine if the study medicine is safe and effective, we will compare participant experiences when they are taking the study medicine to a historical period when they were not. Researchers want to see if the study medicine works to prevent the bleeding episodes commonly experienced by patients with Hemophilia.
Participants will be in this study for about 14 months (approximately 1 month in a Screening period, 12 months receiving treatment, and 1 month in a follow-up period) during which they will visit the study site at least 10 times. If preferred, and if local regulations allow it, 2 of the study visits can be completed at the participant's home instead of at the study site. There will also be 6 scheduled telephone calls approximately every 2 months.