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NCT03992729 · ClinicalTrials.gov registry record
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
A clinical trial of Pregnancy Related, sponsored by Sun Pharmaceutical Industries Limited.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT03992729 is a study of Pregnancy Related that is actively recruiting participants, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 200 participants, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03992729, a study of Pregnancy Related, is actively recruiting participants, sponsored by Sun Pharmaceutical Industries Limited.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication. The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry. These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy. The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.
Conditions Studied
Interventions
- DRUG Pregnant women exposed to tildrakizumab
- DRUG Pregnant women not exposed to tildrakizumab
Study Locations (1)
California
- Christina Chambers - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2028-07-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03992729
The ClinicalTrials.gov registry entry for NCT03992729 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (90% lower). The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions - of which Pregnant women exposed to tildrakizumab is the first listed.
NCT03992729 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03992729 about?
NCT03992729 is a clinical study titled "Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab". This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication. The pregnancy registry cohort study will be conducted by the Organization of ...
What is the current status of trial NCT03992729?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2019-08-29. Estimated completion is 2028-07-31.
What conditions does trial NCT03992729 study?
This clinical trial studies the following conditions: Pregnancy Related.
What interventions are being tested in trial NCT03992729?
The interventions under investigation include: Pregnant women exposed to tildrakizumab (DRUG), Pregnant women not exposed to tildrakizumab (DRUG).
Who is sponsoring clinical trial NCT03992729?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03992729 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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