VIBATIV Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Theravance BioPharma US, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance BioPharma US, Inc.
ClinicalTrials.gov Identifier:
NCT01130324
First received: May 24, 2010
Last updated: March 20, 2014
Last verified: March 2014
  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:


Further study details as provided by Theravance BioPharma US, 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
VIBATIV exposed pregnant women
Pregnant women exposed to VIBATIV (telavancin hydrochloride) during pregnancy where outcome of pregnancy is unknown at the time of enrollment
Drug: telavancin
Observational
Other Names:
  • VIBATIV
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Theravance, Inc. Medical Information 1-855-633-8479

Locations
United States, California
Theravance, Inc. Recruiting
S. San Francisco, California, United States, 94080
Contact: Medical Information       MedInfo@theravance.com   
Sponsors and Collaborators
Theravance BioPharma US, Inc.
Investigators
Principal Investigator: Principal Investigator Theravance BioPharma US, Inc.
  More Information

No publications provided

Responsible Party: Theravance BioPharma US, Inc.
ClinicalTrials.gov Identifier: NCT01130324     History of Changes
Other Study ID Numbers: 0113
Study First Received: May 24, 2010
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 29, 2014