Study Evaluating B-Domain Deleted Recombinant Factor VIII... | NCT00243659

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
A	Experimental		Biological: ReFacto AF
B	Experimental		Biological: ReFacto AF

Name	Type	Description	Arm Group Labels	Other Names
ReFacto AF	Biological		A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients Who Achieved Hemostatic Efficacy After Surgery	Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge	Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.

Eligibility Module

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		La Jolla	California	92093	United States

Results Section

Participant Flow Module

ID	Title	Description
FG000	Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days
FG001	Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days
BG001	Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00022 BG0018 BG00230

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Excellent

Title	Measurements
	OG00015 OG0013

Good

Title	Measurements
	OG000

Secondary

Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge

Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.

The analysis population is the efficacy evaluable at visit five.

Posted

May 2009

Number

patients

6 weeks

ID	Title	Description
OG000	Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days
OG001	Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Fever	General disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Accidental injury	General disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Cellulitis	General disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Hemorrhage	Cardiac disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Factor VIII inhibition	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 affected22 at risk EG0010 affected8 at risk
Cough increased	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Accidental injury	General disorders	Non-systematic Assessment	EG0003 affected22 at risk EG0010 affected8 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Back pain	General disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Cellulitis	General disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Chills	General disorders	Non-systematic Assessment	EG0002 affected22 at risk EG0010 affected8 at risk
Fever	General disorders	Non-systematic Assessment	EG0007 affected22 at risk EG0016 affected8 at risk
Flu syndrome	General disorders	Non-systematic Assessment	EG0003 affected22 at risk EG0010 affected8 at risk
Headache	General disorders	Non-systematic Assessment	EG0003 affected22 at risk EG0011 affected8 at risk
Injection	General disorders	Non-systematic Assessment	EG0005 affected22 at risk EG0010 affected8 at risk
Non-specified drug reaction	General disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Pain	General disorders	Non-systematic Assessment	EG0002 affected22 at risk EG0016 affected8 at risk
Hemorrhage	Cardiac disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Hypertension	Cardiac disorders	Non-systematic Assessment	EG0002 affected22 at risk EG0011 affected8 at risk
Hypotension	Cardiac disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Hypovolemia	Cardiac disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Pallor	Cardiac disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Jaundice	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Mouth ulceration	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0003 affected22 at risk EG0011 affected8 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0011 affected8 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0008 affected22 at risk EG0011 affected8 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Thrombocythemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 affected22 at risk EG0011 affected8 at risk
Bilirubinemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Peripheral edema	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0011 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Plantar fascitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Hypesthesia	Nervous system disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Memory impairment	Nervous system disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Paresthesia	Nervous system disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Cough increased	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Rhinitis	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 affected22 at risk EG0010 affected8 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Vesiculobullous rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0012 affected8 at risk
Abnormal vision	Eye disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Ear disorder	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Hematuria	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Kidney calculus	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Oliguria	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected22 at risk EG0010 affected8 at risk
Scrotal edema	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected22 at risk EG0011 affected8 at risk
Location reaction to procedure	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0003 affected22 at risk EG0011 affected8 at risk

ID	Term
D006467	Hemophilia A
D020141	Hemostatic Disorders

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020147	Coagulation Protein Disorders
D006474	Hemorrhagic Disorders
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011498	Protein Precursors
D001685	Biological Factors

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days			4		19
EG001	Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously			1		7