View Clinical Trial (Medical Research Study)
Ribavirin Pregnancy Registry
| City: |
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Wilmington |
| State: |
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North Carolina |
| Zip Code: |
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28405 |
| Conditions: |
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Birth Defects - Pregnancy Complications - Hepatitis C |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00114712 |
| Primary Contact: |
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Principal Investigator
Susan S Roberts, PhD
INC Research, LLC
Cathy Ryan
Phone: 800 593 2214
Email: pregnancyregistries@incresearch.com
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| Backup Contact: |
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Email: pregnancyregistries@incresearch.com
Stacey Stone
Phone: 800 593 2214
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| Location Contact: |
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Wilmington, North Carolina 28405
United States
Cathy Ryan
Phone: 800-593-2214
Email: pregnancyregistries@incresearch.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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