Text Size

VIBATIV Pregnancy Registry

This study is currently recruiting participants.
Verified January 2013 by Theravance, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT01130324
First received: May 24, 2010
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
Congenital Defects
Infant, Low Birth Weight
 Drug: telavancin

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Theravance, Inc.:

Primary Outcome Measures:
  • Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy [ Time Frame: Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of fetal exposure to VIBATIV on pregnancy outcomes [ Time Frame: Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. ] [ Designated as safety issue: No ]
  • Fetal/neonatal outcomes [ Time Frame: Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. ] [ Designated as safety issue: No ]
  • Infant development and milestones through 12 months of age [ Time Frame: Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women exposed to VIBATIV (Telavancin Hydrochloride)
Pregnant women exposed to VIBATIV during pregnancy where outcome of pregnancy is unknown at the time of enrollment
 Drug: telavancin
Observational
Other Names:
  • VIBATIV
  • ASP9809
  • TD-6424

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130324

Contacts
Contact: VIBATIV Pregnancy Registry Staff 888-658-4228

Locations
United States, Michigan
i3 Drug Safety Recruiting
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
Theravance, Inc.
Investigators
Principal Investigator: Principal Investigator i3 Drug Safety
  More Information

No publications provided

Responsible Party: Theravance, Inc.
ClinicalTrials.gov Identifier: NCT01130324     History of Changes
Other Study ID Numbers: 9809-CL-1409
Study First Received: May 24, 2010
Last Updated: January 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:
VIBATIV
telavancin
Pregnancy
Registry
ASP9809

Additional relevant MeSH terms:
Congenital Abnormalities
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013