Clinical trial NCT00114712: The Ribavirin Pregnancy Registry
Official title: The Ribavirin Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Birth Defects
Pregnancy Complications
Hepatitis C
Keywords: Birth Defects
Pregnancy
Ribavirin
Hepatitis C
Lead sponsor: Syneos Health
Sponsor class: OTHER
Collaborators: name: Aurobindo Pharma Ltd
name: Sandoz
name: Merck Sharp & Dohme LLC
name: Teva Pharmaceuticals USA
name: Zydus Pharmaceuticals USA, Inc.
First posted: 2005-06-17
Enrollment: 477
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Analysis - US

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.

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.

Eligibility criteria: 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.

Exclusion Criteria:

* Females who were not exposed to Ribavirin during the designated time (described above)

Primary outcomes:
measure: To evaluate association between ribavirin and birth defects
timeFrame: At birth outcome, infant follow-up at 6 and 12 months
Secondary outcomes:
measure: Estimate risk of birth defects in exposed pregnancies
timeFrame: At birth outcome, infant follow-up at 6 and 12 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: INC Research, LLC
state: North Carolina
Study officials:
affiliation: Syneos Health
name: Susan Sinclair, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinclair SM, Jones JK, Miller RK, Greene MF, Kwo PY, Maddrey WC. The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment. Drug Saf. 2017 Dec;40(12):1205-1218. doi: 10.1007/s40264-017-0566-6.