רדאר קליני AI
הניסוי הקליני NCT07414511 (HARP) עבור המופיליה A, המופיליה A חמורה, Factor VIII (FVIII), FVIII Deficiency, Carrier of Hemophilia A, Inhibitors, הריון, Maternal Blood Loss, סיבוכי הריון, הפרעת דימום, דימום לאחר לידה, Alloimmunization, X-Linked הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים

Hemophilia A Research Program (HARP) 500 ילדים לאחר לידה

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07414511 (HARP) הוא מחקר מסוג תצפיתי עבור המופיליה A, המופיליה A חמורה, Factor VIII (FVIII), FVIII Deficiency, Carrier of Hemophilia A, Inhibitors, הריון, Maternal Blood Loss, סיבוכי הריון, הפרעת דימום, דימום לאחר לידה, Alloimmunization, X-Linked, שנמצא כעת במצב מגייס. המחקר התחיל ב-31 ביולי 2024 ומתוכנן לכלול 500 משתתפים. המחקר מנוהל על ידי אוניברסיטת וושינגטון וצפוי להסתיים ב-1 באוגוסט 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-17 בפברואר 2026.
סיכום קצר
This study longitudinally observes the intergenerational (mother-child) continuum in hemophilia A from pregnancy through early childhood. Because the study follows mother-child pairs, the study includes both a maternal cohort and a pediatric cohort. Each cohort has a primary goal: for the mother with a severe hemophilia genotype, the overarching primary goal is to understand the risks for pregnancy-associated bleedin...הצג עוד
תיאור מפורט
HARP is a longitudinal observational, decentralized and multisite (with one hybrid site), national prospective cohort study in hemophilia A. Participants will be treated by their HCPs, with no limitations on medical decision-making.

Hemophilia A is an inherited X-linked bleeding disorder caused by deficiency in coagulation factor VIII (FVIII). Severe hemophilia A is defined by a FVIII level < 0.01 IU/dL (or < 1%)....

הצג עוד
כותרת רשמית

Hemophilia A Research Program (HARP): An Observational Intergenerational Cohort Study of Hemophilia A and Factor VIII Immunogenicity

מצבים רפואיים
המופיליה Aהמופיליה A חמורהFactor VIII (FVIII)FVIII DeficiencyCarrier of Hemophilia AInhibitorsהריוןMaternal Blood Lossסיבוכי הריוןהפרעת דימוםדימום לאחר לידהAlloimmunizationX-Linked
פרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:
מזהי מחקר נוספים
מספר NCT
תחילת המחקר (בפועל)
2024-07-31
עדכון אחרון שפורסם
2026-02-17
סיום המחקר (מוערך)
2029-08
משתתפים (מתוכנן)
500
סוג המחקר
תצפיתי
סטטוס
מגייס
מילות מפתח
Pregnancy
Inhibitor
Bleeding
Bleeding Disorder
Maternal Child Health
Hemophilia
Hemophilia A
Hemophilia A Carrier
Hemophilia A Symptomatic Carrier
Coagulation
Factor VIII
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
Maternal Cohort
Inclusion Criteria (mother): * Currently pregnant and prior to 37 weeks gestation * Known or at-risk of having a severe hemophilia A genotype * Pregnant with a fetus at-risk of inheriting severe hemophilia A * Ability to understand and willingness to provide informed consent * 18 years of age or older
לא ישים
Pediatric Cohort Continuation Criteria (Child)
* Severe hemophilia A defined by a baseline factor VIII activity (FVIII:C) \<0.01 international units (IU)/mL (or FVIII:C \< 1%) or a genotype predicted to result in severe hemophilia A * Born to a pregnant mother participating in the study * Absence of discontinuation criteria
לא ישים
Blood Relatives of the Child (may be offered participation)
* First-degree blood relatives (e.g., father, sibling) of the child * Second-degree blood relatives (e.g., aunt, uncle, grandparent, half-sibling) of the child * Any more distant male or female blood relative whose data or samples may be informative for the planned genetic studies of hemophilia and inhibitors
לא ישים
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Primary Endpoint(s)/Outcome(s)
The study primary endpoints/outcomes for the maternal and pediatric cohorts are as follows: • Maternal: Rates of primary PPH, defined as * estimated or quantified blood loss \> 1,000 mL in the first 24 hours PP, or * unplanned transfusion of blood products related to blood loss in the first 24 hours PP. As a subset of primary PPH, severe primary PPH is defined as * estimated or quantified blood loss \> 1,500 mL or requirement of \> 2 units packed red blood cells within 24 hours PP, or * primary PPH with estimated or quantified blood loss \> 1,000 mL and evidence of maternal hemodynamic instability (tachycardia, hypotension) or end organ damage with no other etiology (oliguria, creatinine \> 0.8, etc.). • Pediatric: Rate of development of humoral immune response to FVIII and proportion that progress to clinical inhibitors, defined as * clinical FVIII inhibitor, or * detection of an antibody specific to FVIII.
For mother-child pairs, from enrollment until the child with severe hemophilia A is at least 2 years old*, or until a study discontinuation criteria is met. *This is the minimum duration, the mother-child pairs will be followed for as long as feasible.
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Secondary Endpoint(s)/Outcome(s)
Prioritized Secondary Maternal and Pediatric Endpoints/Outcomes * Maternal: Rate of secondary PPH * Maternal: Development of other clinically significant other bleeding * Pediatric: Development of clinical FVIII inhibitor * Pediatric: Development of IgG1 antibody to FVIII * Pediatric: Development of high-affinity IgG3 or IgG4 antibody to FVIII Additional descriptions of study outcomes and hypotheses to be tested are detailed in the study protocol.
For mother-child pairs, from enrollment until the child with severe hemophilia A is at least 2 years old*, or until a study discontinuation criteria is met. *This is the minimum duration, the mother-child pairs will be followed for as long as feasible.
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
ילד, מבוגר, גיל שלישי
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן

Pregnant individuals who meet the following criteria are eligible for enrollment as study participants:

  • Currently pregnant and prior to 37 weeks gestation
  • Known to have or at-risk of having a severe hemophilia A genotype
  • Pregnant with at least one fetus at-risk of inheriting severe hemophilia A
  • Ability to understand and willingness to provide informed consent
  • 18 years of age or older

Before the 38th week of pregnancy, enrolled participants must meet all the following criteria to continue to remain in the study:

  • The pregnant mother has a severe hemophilia A genotype.
  • A fetus is determined to have a >/= 25% risk of inheriting severe hemophilia A, or prenatal testing indicates a fetus is affected by severe hemophilia A.
  • No other discontinuation criteria have been identified.

Pediatric Continuation / Inclusion Criteria:

Eligibility of the child to continue is assessed by age 8 weeks. Mother-child pairs in which a child meets the following criteria will remain in the study:

  • Severe hemophilia A defined by a baseline FVIII:C < 0.01 IU/mL (or FVIII:C < 1%) or a genotype predicted to cause severe hemophilia A
  • Born to a mother participating in the study

Thereafter, mothers and their children will continue in the study as long as no new discontinuation criteria occur.

Inclusion Criteria for Blood Relatives:

Blood relatives of the child may be offered participation if one of the following criteria are met:

  • First-degree blood relatives (e.g., father, sibling) of the child
  • Second-degree blood relatives (e.g., aunt, uncle, grandparent, half-sibling) of the child
  • Any more distant male or female blood relative whose data or samples may be informative for the planned genetic studies of hemophilia and inhibitors

Exclusion/Discontinuation Criteria:

Maternal: For the pregnant person, exclusion or discontinuation criteria are as follows:

  • Genetic testing is negative for a severe hemophilia A genotype
  • Prenatal clinical diagnostic testing that indicates there is no fetus affected with severe hemophilia A
  • Presence of another clinically significant bleeding disorder
  • Participation in another study for which any blood collection total would exceed safety limits defined in this study
  • Will deliver outside the United States or plans for regular pediatric care for the child to be delivered outside the United States
  • Is a prisoner
  • Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study
  • Inability for study team to obtain translated study documents in time for participation if participant is not fluent in English

Pediatric: For the child, discontinuation criteria are as follows:

  • Infant does not have severe hemophilia A defined by a baseline FVIII:C < 0.01 IU/mL (or FVIII:C < 1%) or does not have a genotype predicted to cause severe hemophilia A
  • Mother or child did not have minimal required study samples or data collected before birth, around the time of delivery, or in the neonatal period
  • Child has another clinically significant bleeding disorder
  • Child has a clinically severe immune disorder
  • Participation in another study for which any blood collection total would exceed safety limits defined in this study
  • Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study
University of Washington logoאוניברסיטת וושינגטון398 מחקרים פעילים לחקור
הגורם האחראי למחקר
Jill Johnsen, חוקר ראשי, Professor, Division of Hematology and Oncology, University of Washington
איש קשר מרכזי למחקר
איש קשר: Jill M Johnsen, MD, 206 568-2230, [email protected]
איש קשר: G Shellye Horowitz, MA, [email protected]
1 מיקומי המחקר ב-1 מדינות

Washington

University of Washington, Seattle, Washington, 98109, United States
Shellye Horowitz, MA, איש קשר, 206-568-2230, [email protected]
Danielle Drury-Stewart, PhD, איש קשר, [email protected]
Jill Johnsen, MD, חוקר ראשי
מגייס