Yervoy Pregnancy Surveillance Study
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02854488
Collaborator
(none)
0
1
53.1
0
Study Details
Study Description
Brief Summary
The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
Actual Study Start Date
:
Sep 30, 2016
Actual Primary Completion Date
:
Feb 5, 2021
Actual Study Completion Date
:
Mar 5, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Women Exposed to Yervoy (ipilimumab) During Pregnancy Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies |
Drug: Yervoy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant [Birth up to 12 months]
- Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant [Birth up to 12 months]
- Delays in developmental milestones [Birth up to 5 Years]
- Clinical Signs of Immune or Endocrine Dysfunction [Birth up to 5 Years]
- Clinical Signs of Autoimmune Disorders [Birth up to 5 Years]
- Clinical Signs of Serious Infections and Malignancy [Birth up to 5 Years]
- Adverse Pregnancy Outcomes [Time of Conception up to Birth]
Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
Exclusion Criteria:
-
Women whose ipilimumab exposure is outside the window of pregnancy exposure
-
Pregnancies for which there is only paternal exposure to Yervoy
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UBC | Baltimore | Maryland | United States |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02854488
Other Study ID Numbers:
- CA184-487
First Posted:
Aug 3, 2016
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022