Status:
TERMINATED
The Ribavirin Pregnancy Registry
Lead Sponsor:
Syneos Health
Collaborating Sponsors:
Aurobindo Pharma Ltd
Sandoz
Conditions:
Birth Defects
Pregnancy Complications
Eligibility:
FEMALE
18-65 years
Brief 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 R...
Detailed Description
Ribavirin, a nucleoside analog with antiviral activity, is used in combination with interferons or pegylated interferons for the treatment of chronic hepatitis C (HCV). Extensive clinical studies have...
Eligibility Criteria
Inclusion
- Pregnancy occurring to one of the following groups while the patient or sexual partner was on ribavirin and/or within six months after therapy stopped:
- Female patients who become pregnant on ribavirin therapy, or
- Female patients who start ribavirin therapy while pregnant, or
- Female patients who become pregnant post-ribavirin therapy (defined as the six month time period after therapy has stopped) or
- Females who become pregnant while their male sexual partner is on ribavirin therapy or
- Females who are pregnant when their male sexual partner starts ribavirin therapy, or
- Females who become pregnant while their male sexual partner is in the post-ribavirin therapy period (defined as the six month time period after therapy has stopped).
- Timing of the prenatal exposure to ribavirin, no broader than within six months prior to pregnancy or trimester during which the exposure took place.
- Sufficient information to determine whether the pregnancy is prospectively registered (i.e., whether the outcome of pregnancy was known at the time of the report).
- Date the pregnancy exposure report is registered.
- Source of the report (health care professional, pregnant patient, or male sexual partner).
- Report contact information to allow for follow-up.
Exclusion
- Females who were not exposed to Ribavirin during the designated time (described above)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT00114712
Start Date
January 1 2004
End Date
November 2 2020
Last Update
December 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
INC Research, LLC
Wilmington, North Carolina, United States, 28405