Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114712
Status:
TERMINATED
Last Update Posted:
2020-12-14
First Post:
2005-06-16
Brief Title:
The Ribavirin Pregnancy Registry
Sponsor:
Syneos Health
Organization:
Syneos Health
Study Overview
Official Title:
The Ribavirin Pregnancy Registry
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per the Division of Project Management Office of Regulatory Operations Office of Generic Drugs FDA there is no regulatory requirement to continue this Registry
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RPR
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 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 partners pregnancy or during the 6 months before pregnancy are encouraged to contact the Registry
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 demonstrated that combination therapy with ribavirin and interferons or pegylated interferons are efficacious treatments for HCV However ribavirin has been assigned a FDA Pregnancy Category X classification indicating that it should not be used in women who are pregnant or in men whose partners may become pregnant Because the incidence of HCV is highest in the group with the highest reproductive potential the 25 - 45 year age group CDC 2001 it is likely that inadvertent pregnancy exposures will occur and should be monitored The primary objectives of this Registry are
To evaluate the association between ribavirin and birth defects occurring in offspring of female patients exposed to ribavirin during pregnancy or within six months after therapy has stopped
To evaluate the association between ribavirin and birth defects occurring in offspring of females exposed to ribavirin during pregnancy or within six months after therapy has stopped through their male sexual partners taking ribavirin
To evaluate the association between ribavirin and birth defects occurring in offspring of female patients exposed to ribavirin during pregnancy or within six months after therapy has stopped
To evaluate the association between ribavirin and birth defects occurring in offspring of females exposed to ribavirin during pregnancy or within six months after therapy has stopped through their male sexual partners taking ribavirin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None