Birth DefectsRPRNCT00114712
The Ribavirin Pregnancy Registry
An observational study of Birth Defects and Pregnancy Complications, run by Syneos Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Birth Defects, Pregnancy Complications, Hepatitis C
- How many people
- 477 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to 2 Nov 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary Analysis - US
Who may be able to join
- 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
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- 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.
Who cannot join
- Females who were not exposed to Ribavirin during the designated time (described above)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Birth Defects, Pregnancy Complications, Hepatitis C
- Keywords
- Birth Defects, Pregnancy, Ribavirin, Hepatitis C
- Medical subject headings
- Congenital Abnormalities, Pregnancy Complications, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At birth outcome, infant follow-up at 6 and 12 months
Secondary outcomes (1)
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.
Measured: At birth outcome, infant follow-up at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2005 (estimated)
- Study startJan 2004
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Per the Division of Project Management, Office of Regulatory Operations, Office of Generic Drugs, FDA there is no regulatory requirement to continue this Registry.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- Aurobindo Pharma Ltd, Sandoz, Merck Sharp & Dohme LLC, Teva Pharmaceuticals USA, Zydus Pharmaceuticals USA, Inc.
- Responsible party
- Sponsor
- Investigators
- Susan Sinclair, PhD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114712
- Sponsor's protocol ID
- RPR-1
- Acronym
- RPR
- Status last verified
- Mar 2020
- First submitted
- 16 Jun 2005
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A condensed version of the annual interim report is available to healthcare providers upon request.
Publications
Sinclair SM, Jones JK, Miller RK, Greene MF, Kwo PY, Maddrey WC. The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment. Drug Saf. 2017 Dec;40(12):1205-1218. doi: 10.1007/s40264-017-0566-6.
PubMed 28689333
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ribavirin Pregnancy Registry
- ClinicalTrials.gov ID
- NCT00114712
- Acronym / sponsor ID
- RPR / RPR-1
- Conditions
- Birth Defects, Pregnancy Complications, Hepatitis C
- Keywords
- Birth Defects, Pregnancy, Ribavirin, Hepatitis C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Per the Division of Project Management, Office of Regulatory Operations, Office of Generic Drugs, FDA there is no regulatory requirement to continue this Registry.
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Aurobindo Pharma Ltd, Sandoz, Merck Sharp & Dohme LLC, Teva Pharmaceuticals USA, Zydus Pharmaceuticals USA, Inc.
- Study start
- Jan 2004
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 17 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Analysis - US
Key inclusion criteria (12 listed)
- 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:
- 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).
Key exclusion criteria (1 listed)
- Females who were not exposed to Ribavirin during the designated time (described above)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Estimate risk of birth defects in exposed pregnancies
Time frame: At birth outcome, infant follow-up at 6 and 12 months
Results and safety
The study was stopped early (reason given: Per the Division of Project Management, Office of Regulatory Operations, Office of Generic Drugs, FDA there is no regulatory requirement to continue this Registry.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 28689333Sinclair SM, Jones JK, Miller RK, Greene MF, Kwo PY, Maddrey WC. The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment. Drug Saf. 2017 Dec;40(12):1205-1218. doi: 10.1007/s40264-017-0566-6.
- Individual participant dataSharing planned: Yes. A condensed version of the annual interim report is available to healthcare providers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Sinclair, PhD principal investigator
Syneos Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Defects and Pregnancy Complications, run by Syneos Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Per the Division of Project Management, Office of Regulatory Operations, Office of Generic Drugs, FDA there is no regulatory requirement to continue this Registry.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate association between ribavirin and birth defects (time frame: At birth outcome, infant follow-up at 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.