- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00342862
AMEVIVE® Pregnancy Registry
Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects.
The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research. The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Wilmington, North Carolina, United States, 28405
- INC Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time during pregnancy
- Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively)
- Provide verbal consent to participate in the Registry, and
- Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1. Amevive Exposure
Pregnant women with psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively
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Observational
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate pattern or increase in major birth defects in children of women w/ psoriasis who were exposed to AMEVIVE® at any time within the 8 wks prior to conception, or at any time during pregnancy, where outcome of the pregnancy is unknown prospectively
Time Frame: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
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At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®
Time Frame: At 2 months post estimated delivery date
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At 2 months post estimated delivery date
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To evaluate gestational age, body weight, gender, head circumference, and body length in live born infants exposed to AMEVIVE®
Time Frame: At 2 months post estimated delivery date
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At 2 months post estimated delivery date
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To evaluate appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 and 5 minutes of age in live born infants exposed to AMEVIVE®
Time Frame: At 2 months post estimated delivery date
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At 2 months post estimated delivery date
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To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE®
Time Frame: At 2 months and 12 months post estimated delivery date
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At 2 months and 12 months post estimated delivery date
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To evaluate clinically significant infections with unusual organisms, not requiring hospitalization in live born infants exposed to AMEVIVE®
Time Frame: At 2 months and 12 months post estimated delivery date
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At 2 months and 12 months post estimated delivery date
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To evaluate malignancies in live born infants exposed to AMEVIVE®
Time Frame: At 2 months and 12 months post estimated delivery date
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At 2 months and 12 months post estimated delivery date
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vice President Medical Affairs, Astellas Pharma Global Development
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0485-CL-0002
- C-739
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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