Ribavirin Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by INC Research
Sponsor:
Collaborators:
Aurobindo Pharma USA
Genentech, a member of the Roche Group
Sandoz Pharmaceuticals Inc.
Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co., Inc.
Teva Pharmaceuticals USA
Kadmon Pharmaceuticals, LLC
Zydus Pharmaceuticals USA, Inc.
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT00114712
First received: June 16, 2005
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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 Phase
Birth Defects
Pregnancy Complications
Hepatitis C
Phase 4

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Ribavirin Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by INC Research:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 250
Study Start Date: January 2004
Estimated Study Completion Date: December 2016
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Analysis - US

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114712

Contacts
Contact: Earle Griffith, PMP 800 593 2214 pregnancyregistries@incresearch.com
Contact: Stacey Stone 800 593 2214 pregnancyregistries@incresearch.com

Locations
United States, North Carolina
INC Research, LLC Recruiting
Wilmington, North Carolina, United States, 28405
Contact: Earle Griffith, PMP    800-593-2214    pregnancyregistries@incresearch.com   
Sponsors and Collaborators
INC Research
Aurobindo Pharma USA
Genentech, a member of the Roche Group
Sandoz Pharmaceuticals Inc.
Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co., Inc.
Teva Pharmaceuticals USA
Kadmon Pharmaceuticals, LLC
Zydus Pharmaceuticals USA, Inc.
Investigators
Principal Investigator: Susan Sinclair, PhD INC Research
  More Information

No publications provided

Responsible Party: INC Research
ClinicalTrials.gov Identifier: NCT00114712     History of Changes
Other Study ID Numbers: RPR-1
Study First Received: June 16, 2005
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INC Research:
Birth Defects
Pregnancy
Ribavirin
Hepatitis C

Additional relevant MeSH terms:
Pregnancy Complications
Hepatitis
Hepatitis C
Congenital Abnormalities
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014