The Ribavirin Pregnancy Registry

NCT00114712 | Terminated DMC

• 1 other identifier: RPR-1
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Birth Defects; Pregnancy Complications; Hepatitis C

Keywords

Birth Defects; Pregnancy; Ribavirin; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Estimate risk of birth defects in exposed pregnancies

  At birth outcome, infant follow-up at 6 and 12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Analysis - US

You may qualify if:

• 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.

You may not qualify if:

• Females who were not exposed to Ribavirin during the designated time (described above)

Sponsors & Collaborators

• Syneos Health: lead
• Aurobindo Pharma Ltd: collaborator
• Sandoz: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Teva Pharmaceuticals USA: collaborator
• Zydus Pharmaceuticals USA, Inc.: collaborator

Study Sites (1)

INC Research, LLC

Wilmington, North Carolina, 28405, United States

Location

Related Publications (1)

• 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.

  PMID: 28689333 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities; Pregnancy Complications; Hepatitis C

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Susan Sinclair, PhD

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2005
• First Posted: June 17, 2005
• Study Start: January 1, 2004
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)