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Recruitment slow as single center conducting in rare disease
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neumega (Interleukin 11, IL-11) | Experimental | Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neumega (Oprelvekin, Interleukin 11, IL-11) | Drug | 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Surgical Blood Loss | Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure. | 4 weeks |
| Volume of Blood Transfusion | The volume of blood transfusion required (units of blood) after the surgical procedure. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA). | The number of subjects with detectable VWFmRNA. | 4 weeks per subject |
| Number of Subjects Who Experienced Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret V Ragni, MD, MPH | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hemophilia Center of Western PA | Pittsburgh | Pennsylvania | 15213-4306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Jankowitz RC, Nichols TC, Ragni MV. Recombinant IL-11 (Neumega, rhIL-11) increases plasma Von Willebrand Factor in Type 1 Von Willebrand Disease. Blood 108: 1003, 2006 (abstract). | ||
| 18680527 | Background | Ragni MV, Jankowitz RC, Chapman HL, Merricks EP, Kloos MT, Dillow AM, Nichols TC. A phase II prospective open-label escalating dose trial of recombinant interleukin-11 in mild von Willebrand disease. Haemophilia. 2008 Sep;14(5):968-77. doi: 10.1111/j.1365-2516.2008.01827.x. Epub 2008 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neumega (Interleukin 11, IL-11) | Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neumega (Interleukin 11, IL-11) | Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume of Surgical Blood Loss | Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure. | Posted | Number | cc | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neumega (Interleukin 11, IL-11) | Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Non-systematic Assessment | mild headache |
There were too few subjects for reporting in a manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margaret Ragni, Professor of Medicine | University of Pittsburgh | 412-209-7288 | ragni@dom.pitt.edu |
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| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C105308 | oprelvekin |
| D017370 | Interleukin-11 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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mild headache, nausea
| The time frame is within 4 weeks of surgery. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Volume of Blood Transfusion | The volume of blood transfusion required (units of blood) after the surgical procedure. | Posted | Number | units of blood | 4 weeks |
|
|
|
| Secondary | No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA). | The number of subjects with detectable VWFmRNA. | Even though three subjects were enrolled, none were assessed for VWFmRNA because the study stopped due to poor enrollment related to insurers requiring surgeries outside of UPMC. | Posted | 4 weeks per subject |
|
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| Secondary | Number of Subjects Who Experienced Adverse Events | mild headache, nausea | Posted | Number | participants | The time frame is within 4 weeks of surgery. |
|
|
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| 0 |
| 3 |
| 2 |
| 3 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment | mild nausea |
|
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| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |