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The Ribavirin Pregnancy Registry

NCT00114712 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 477

Last updated 2020-12-14

No results posted yet for this study

Summary

Ribavirin should be avoided during pregnancy and during the 6 months before pregnancy in both the female and the male sexual partner. If a pregnancy occurs and is reported to the Ribavirin Pregnancy Registry, the Registry will follow the pregnant woman throughout pregnancy. The Registry will also follow the infant until 1 year of age. The goal of the Registry is to learn more about the effects of ribavirin on pregnancy and the risk for birth defects. Pregnant women exposed to ribavirin, either by taking ribavirin (during pregnancy or 6 months before pregnancy) or through a male sexual partner (who took ribavirin during the female partner's pregnancy or during the 6 months before pregnancy), are encouraged to contact the Registry.

Conditions

Sponsors & Collaborators

  • Aurobindo Pharma Ltd

    collaborator INDUSTRY

  • Sandoz

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Zydus Pharmaceuticals USA, Inc.

    collaborator INDUSTRY

  • Syneos Health

    lead OTHER

Principal Investigators

  • Susan Sinclair, PhD · Syneos Health

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2020-11-02
Completion
2020-11-02

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00114712 on ClinicalTrials.gov