Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151125
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2005-09-06
Brief Title:
Phase II Study of IL-11 Neumega in Von Willebrand Disease
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 rhIL-11 Neumega in Subjects With Type 1 Von Willebrand Disease
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is testing the use of rhIL-11 recombinant interleukin 11 Neumega in individuals with Von Willebrand disease The purpose is to evaluate
1 if rhIL-11 corrects VWF Von Willebrand Factor levels to normal
2 if rhIL-11 and DDAVP together will boost VWF levels even higher
3 the onset peak and duration of rhIL-11 effect
4 if rhIL-11 is safe in individuals with Von Willebrand Disease
1 if rhIL-11 corrects VWF Von Willebrand Factor levels to normal
2 if rhIL-11 and DDAVP together will boost VWF levels even higher
3 the onset peak and duration of rhIL-11 effect
4 if rhIL-11 is safe in individuals with Von Willebrand Disease
Detailed Description:
This is a prospective single center open-label escalating dose Phase II comparison study of interleukin-11 rhIL-11 Neumega in subjects with type 1 Von Willebrand Disease VWD
The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease
Study subjects will include the following subjects
1 age 18 years of age
2 diagnosis of VWD confirmed by 2a at least 2 of 4 abnormal vWD-related coagulation tests 2b a past bleeding history
A total of 10-16 subjects are anticipated to be enrolled and complete the study The specific aims of the study are
1 to compare the hemostatic efficacy of three escalating doses of rhIL-11
2 to determine the biologic effects of rhIL-11
3 to determine whether DDAVP when given after the seventh daily dose of rhIL-11 enhances hemostatic efficacy or rhIL-11
4 to compare the safety of three escalating doses of rhIL-11
Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range or at least to 2-3 times baseline
Safety will be based on the number and frequency of adverse reactions including fever headache fatigue arthralgias myalgias fluid retention and edema
The study will last up to 4 weeks per subject and for 24 months for the entire study
The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease
Study subjects will include the following subjects
1 age 18 years of age
2 diagnosis of VWD confirmed by 2a at least 2 of 4 abnormal vWD-related coagulation tests 2b a past bleeding history
A total of 10-16 subjects are anticipated to be enrolled and complete the study The specific aims of the study are
1 to compare the hemostatic efficacy of three escalating doses of rhIL-11
2 to determine the biologic effects of rhIL-11
3 to determine whether DDAVP when given after the seventh daily dose of rhIL-11 enhances hemostatic efficacy or rhIL-11
4 to compare the safety of three escalating doses of rhIL-11
Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range or at least to 2-3 times baseline
Safety will be based on the number and frequency of adverse reactions including fever headache fatigue arthralgias myalgias fluid retention and edema
The study will last up to 4 weeks per subject and for 24 months for the entire study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0403006 | OTHER | protocol id | None |