Hepatitis C Clinical Trial
— RPROfficial title:
The Ribavirin Pregnancy Registry
NCT number | NCT00114712 |
Other study ID # | RPR-1 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 2004 |
Est. completion date | November 2, 2020 |
Verified date | March 2020 |
Source | Syneos Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient 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.
Status | Terminated |
Enrollment | 477 |
Est. completion date | November 2, 2020 |
Est. primary completion date | November 2, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | INC Research, LLC | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Syneos Health | Aurobindo Pharma Ltd, Merck Sharp & Dohme Corp., Sandoz, Teva Pharmaceuticals USA, Zydus Pharmaceuticals USA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate association between ribavirin and birth defects | 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. |
At birth outcome, infant follow-up at 6 and 12 months | |
Secondary | Estimate risk of birth defects in exposed pregnancies | 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. |
At birth outcome, infant follow-up at 6 and 12 months |
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