Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ribavirin Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by INC Research
Sponsor:
Collaborators:
Aurobindo Pharma
Genentech, Inc.
Sandoz
Merck Sharp & Dohme Corp.
Teva Pharmaceuticals USA
Zydus Pharmaceuticals USA, Inc.
Kadmon Corporation, LLC
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT00114712
First received: June 16, 2005
Last updated: August 29, 2016
Last verified: August 2016

June 16, 2005
August 29, 2016
January 2004
December 2024   (final data collection date for primary outcome measure)
To evaluate association between ribavirin and birth defects [ Time Frame: At birth outcome, infant follow-up at 6 and 12 months ] [ Designated as safety issue: Yes ]

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.

Not Provided
Complete list of historical versions of study NCT00114712 on ClinicalTrials.gov Archive Site
Estimate risk of birth defects in exposed pregnancies [ Time Frame: At birth outcome, infant follow-up at 6 and 12 months ] [ Designated as safety issue: Yes ]

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.

Not Provided
Not Provided
Not Provided
 
Ribavirin Pregnancy Registry
Ribavirin Pregnancy Registry
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.

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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample
Primary Analysis - US
  • Birth Defects
  • Pregnancy Complications
  • Hepatitis C
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2025
December 2024   (final data collection date for primary outcome measure)

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)
Female
18 Years to 65 Years   (Adult)
No
Contact: Earle Griffith, PMP 800 593 2214 pregnancyregistries@incresearch.com
Contact: Stacey Stone 800 593 2214 pregnancyregistries@incresearch.com
United States
 
NCT00114712
RPR-1
Yes
Yes
A condensed version of the annual interim report is available to healthcare providers upon request.
INC Research
INC Research
  • Aurobindo Pharma
  • Genentech, Inc.
  • Sandoz
  • Merck Sharp & Dohme Corp.
  • Teva Pharmaceuticals USA
  • Zydus Pharmaceuticals USA, Inc.
  • Kadmon Corporation, LLC
Principal Investigator: Susan Sinclair, PhD INC Research
INC Research
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP