The Ribavirin Pregnancy Registry (RPR)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00114712 |
|
Recruitment Status :
Recruiting
First Posted : June 17, 2005
Last Update Posted : March 16, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Birth Defects Pregnancy Complications Hepatitis C |
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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | The Ribavirin Pregnancy Registry |
| Study Start Date : | January 2004 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | December 2025 |
- To evaluate association between ribavirin and birth defects [ Time Frame: At birth outcome, infant follow-up at 6 and 12 months ]
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.
- Estimate risk of birth defects in exposed pregnancies [ Time Frame: At birth outcome, infant follow-up at 6 and 12 months ]
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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114712
| Contact: Earle Griffith, PMP | 800 593 2214 | pregnancyregistries@incresearch.com | |
| Contact: Stacey Stone | 800 593 2214 | pregnancyregistries@incresearch.com |
| United States, North Carolina | |
| INC Research, LLC | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Contact: Earle Griffith, PMP 800-593-2214 pregnancyregistries@incresearch.com | |
| Principal Investigator: | Susan Sinclair, PhD | INC Research |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | INC Research |
| ClinicalTrials.gov Identifier: | NCT00114712 History of Changes |
| Other Study ID Numbers: |
RPR-1 |
| First Posted: | June 17, 2005 Key Record Dates |
| Last Update Posted: | March 16, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | A condensed version of the annual interim report is available to healthcare providers upon request. |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by INC Research:
|
Birth Defects Pregnancy Ribavirin Hepatitis C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis C Pregnancy Complications Congenital Abnormalities Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Flaviviridae Infections RNA Virus Infections Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |