RPR: The Ribavirin Pregnancy Registry

Sponsor

Syneos Health (Other)

Overall Status

Terminated

CT.gov ID

NCT00114712

Collaborator

Aurobindo Pharma Ltd (Industry), Sandoz (Industry), Merck Sharp & Dohme LLC (Industry), Teva Pharmaceuticals USA (Industry), Zydus Pharmaceuticals USA, Inc. (Industry)

477

Enrollment

Location

202.1

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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 partner's pregnancy or during the 6 months before pregnancy), are encouraged to contact the Registry.

Condition or Disease	Intervention/Treatment	Phase
Birth Defects Pregnancy Complications Hepatitis C

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

477 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Ribavirin Pregnancy Registry

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Nov 2, 2020

Actual Study Completion Date :

Nov 2, 2020

Outcome Measures

Primary Outcome Measures

To evaluate association between ribavirin and birth defects [At birth outcome, infant follow-up at 6 and 12 months]
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.

Secondary Outcome Measures

Estimate risk of birth defects in exposed pregnancies [At birth outcome, infant follow-up at 6 and 12 months]
Attempt to estimate the risk of birth defects occurring in offspring of female patients exposed to ribavirin during pregnancy or within six months after therapy has stopped, and detect any increase in the prevalence or pattern of birth defects among these pregnancies. Attempt to estimate the risk of 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 detect any increase in the prevalence or pattern of birth defects among these pregnancies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.