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AMEVIVE® Pregnancy Registry

NCT ID: NCT00342862

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-12-31

Study Completion Date

2011-12-31

Brief Summary

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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).

Detailed Description

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Prospective reports will be collected from pregnant subjects, health care provider (HCP), or Astellas Product Safety Management staff. Data from the pregnant subjects will be collected at 4 to 5 months of pregnancy by telephone interviews with the Registry. The Registry will also contact the subject at 2 months and 12 months after the estimated delivery date (EDD) for post-natal \& pediatric follow-up. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 2 months and 12 months of age. If a birth defect is reported, targeted follow-up will be conducted.

Conditions

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Pregnancy

Keywords

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Pregnancy Amevive alefacept Registry Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Amevive exposure

Intervention Type DRUG

Observational

Interventions

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Amevive exposure

Observational

Intervention Type DRUG

Other Intervention Names

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alefacept ASP0485

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vice President Medical Affairs

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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INC Research

Wilmington, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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C-739

Identifier Type: -

Identifier Source: secondary_id

0485-CL-0002

Identifier Type: -

Identifier Source: org_study_id

NCT00168675

Identifier Type: -

Identifier Source: nct_alias