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VIBATIV Pregnancy Registry

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: telavancin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
Principal Investigator, Study Director, Affiliation: Theravance Biopharma Antibiotics, Inc.

Overall contact:
Theravance Biopharma Antibiotics, Inc. Medical Information, Phone: 1-855-633-8479

Summary

The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.

Clinical Details

Official title: VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy

Secondary outcome:

Effect of fetal exposure to VIBATIV on pregnancy outcomes

Fetal/neonatal outcomes

Infant development and milestones through 12 months of age

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female patients who were exposed to VIBATIV at any time during pregnancy

- Outcome of pregnancy is unknown at the time of enrollment

Locations and Contacts

Theravance Biopharma Antibiotics, Inc. Medical Information, Phone: 1-855-633-8479

Theravance Biopharma Antibiotics, Inc., South San Francisco, California 94080, United States; Recruiting
Additional Information

Starting date: November 2009
Last updated: January 2, 2015

Page last updated: August 23, 2015

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