Terminated/Withdrawn
Sponsor ID
20080046

Nplate® Pregnancy Exposure RegistryNPER

Sponsor ID
20080046
Clinicaltrials.gov ID
NCT02090088
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate® therapy at any time during the pregnancy.

Additional Study Details

Phase
N/A
Product
romiplostim
Type
Observational
Masking
N/A
Enrollment
4
Additional Study Details

Protocol Summary

Primary Outcome Measures

Major birth defects

Timeframe: 12 months

Secondary Outcome Measures

Minor birth defects

Timeframe: 12 months

Minor birth defects

Timeframe: 12 months

Spontaneous and elective abortions, stillbirths

Timeframe: 9 months

Low birth weight

Timeframe: 12 months

IUGR

Timeframe: 12 months

All adverse events

Timeframe: 21 months

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.