DRUG
Desmopressin
Desmopressin or DDAVP will be administered intravenously (IV) via a nontraumatic peripheral IV line at a dose of 0.3 mcg/kg over 30 minutes.
Characterization of Laboratory Response to DDAVP in Adult Hemophilia A Carriers
Status
Completed
Phase
Phase 1
Enrollment
2
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this study is to determine how female hemophilia A carriers respond to a medication called DDAVP (Desmopressin).
Full detailed description
DDAVP (Desmopressin) is commonly used in the treatment of persons with bleeding disorders such as hemophilia, von Willebrand disease, or qualitative platelet disorders to help them clot better. The investigator wants to assess the increase in the subjects' clotting factors in response to intravenous DDAVP (Desmopressin) and the levels of these internal clotting factors will be measured at different times after the medication is given. The investigator will compare the response to DDAVP (Desmopressin) in adult hemophilia A carriers to women with a diagnosis of qualitative platelet dysfunction.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jul 22, 2015
Study start
Jul 2015
Primary completion
Jun 15, 2018
Study completion
Jun 15, 2018
Results posted
Not reported
Registry updated
Jul 16, 2018
Outcomes
What the study measures.
Primary outcomes
Percentage of subjects that achieve and sustain >50% increase in Factor VIII antigen levels
Time frame · 240 minutes
After administration of intravenous Desmopressin (DDAVP) at 0.3mcg/kg, the percentage of subjects that achieve and sustain Factor VIII antigen (FVIII:C) levels \>50% at 240 minutes as compared to baseline will be recorded. The levels of Factor VIII antigen (FVIII:C) will be measured using a one-stage assay. The laboratory response between carriers and the control group will be compared and the percentage of subjects that have greater than a 2-fold response from baseline and sustainment of Factor VIII antigen (FVIII:C) \>50% at 240 minutes will be recorded. A lower percent of hemophilia A carriers who maintain levels of Factor VIII antigen (FVIII:C) \>50% at 240 minutes indicates that the laboratory response and sustainment of Factor VIII antigen (FVIII:C) in response to Desmopressin (DDAVP) in adult hemophilia A carriers is reduced as compared to the control group.
Secondary outcomes
Change in the time-course response of Factor VIII antigen levels
Time frame · Baseline, 240 minutes
After administration of intravenous Desmopressin (DDAVP) at 0.3mcg/kg, the carriers will be stratified by the type of mutation (mild or severe). The levels of Factor VIII antigen will be measured using a one-stage assay at baseline and 240 minutes. The levels of Factor VIII antigen in hemophilia carriers with mild and severe mutations will be recorded.
Change in the time-course response of von Willebrand factor antigen (vWF:Ag) levels
Time frame · Baseline, 240 minutes
After administration of intravenous Desmopressin (DDAVP) at 0.3mcg/kg, the carriers will be stratified by the type of mutation (mild or severe). The levels of von Willebrand factor antigen (vWF:Ag) will be measured using turbidometric assay at baseline and 240 minutes. The levels of von Willebrand factor antigen (vWF:Ag) in hemophilia carriers with mild and severe mutations will be recorded.
Mean FVIII:C/vWF:Ag ratio in subjects with the baseline FVIII:C/vWF:Ag ratio of 1
Time frame · 240 minutes
The sustainment of Factor VIII antigen (FVIII:C) levels in subjects with Factor VIII antigen:von Willebrand factor antigen (FVIII:C:vWF:Ag) ratio of 1will be assessed. The levels of Factor VIII antigen and von Willebrand factor antigen will be measured using a one-stage assay and turbidometric assays respectively. The subjects that have a baseline FVIII:C:vWF:Ag =1 will have their FVIII:C:vWF:Ag ratio assessed at 240 minutes.
Mean FVIII:C/vWF:Ag ratio in subjects with the baseline FVIII:C/vWF:Ag ratio of <1
Time frame · 240 minutes
The sustainment of Factor VIII antigen (FVIII:C) levels in subjects with Factor VIII antigen:von Willebrand factor antigen (FVIII:C:vWF:Ag) ratio of \<1 will be assessed. The levels of Factor VIII antigen and von Willebrand factor antigen will be measured using a one-stage assay and turbidometric assays respectively. The subjects that have a baseline FVIII:C:vWF:Ag \<1 will have their FVIII:C:vWF:Ag ratio assessed at 240 minutes.
Mean FVIII:C/vWF:Ag ratio in subjects with the baseline FVIII:C/vWF:Ag ratio of >1
Time frame · 240 minutes
The sustainment of Factor VIII antigen (FVIII:C) levels in subjects with Factor VIII antigen:von Willebrand factor antigen (FVIII:C:vWF:Ag) ratio of \>1will be assessed. The levels of Factor VIII antigen and von Willebrand factor antigen will be measured using a one-stage assay and turbidometric assays respectively. The subjects that have a baseline FVIII:C:vWF:Ag \>1 will have their FVIII:C:vWF:Ag ratio assessed at 240 minutes.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: Inclusion criteria for hemophilia A carriers: * Females 18-60 years of age at time of enrollment * Genetically verified or obligate hemophilia A carrier (mother of 2 boys with hemophilia A, daughter of a father with hemophilia A or mother of a son and another male relative with hemophilia A) * To stratify patients by carriage of mutation type 10 hemophilia carriers of mild mutations that are predicted to lead to reduced FVIII secretion, protein stability or thrombin cleavage site interference and 10 hemophilia carriers of severe mutations that lead to predicted negative cross reactive material will be selected. Predicted FVIII function of the mutation will be verified by EAHAD (European Association for Haemophilia and Allied Disorders) Coagulant Factor Variant Database at www.eahad-db.org) * Weight \>40kg to ensure volumes of blood to be drawn are within accepted safe range Inclusion criteria for non-hemophilia A carriers (Females with mild qualitative platelet dysfunction): * Females 18-60 years of age at time of enrollment * Whole blood or platelet rich plasma lumiaggregometry consistent with reduced aggregation to at least 1 agonist on at least one occasion (excluding evidence of Glanzmanns Thrombasthenia or Bernard Soulier Syndrome) or determined by primary hematologist as having a qualitative platelet disorder * Age-matched by 10 years to carrier enrolled * Weight \>40kg to ensure volumes of blood to be drawn are within accepted safe range Exclusion Criteria: * Personal history of concomitant bleeding or clotting disorder * Cardiac condition that requires the daily use of Aspirin or Clopidogrel * Inability to comply with fluid restriction protocol for 24 hours following Desmopressin (DDAVP) * Personal history of a myocardial infarction, renal or hepatic insufficiency or epilepsy
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Children's Hospital of Atlanta Egleston
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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