Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-25 @ 4:48 AM
Study NCT ID:
NCT00455832
Status:
COMPLETED
Last Update Posted:
2012-02-29
First Post:
2007-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
Sponsor:
Foundation for Liver Research
Organization:
Study Overview
Official Title:
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRIS
Brief Summary:
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.
Detailed Description:
During and six months after treatment with peginterferon alpha and ribavirin strict use of birth control is recommended (the producers advice two reliable forms) for both men and women because ribavirin has teratogenic and/or embryo-lethal effects in animal studies.
In cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin elective termination of the pregnancy is usually recommended. However three cases of births after paternal exposure are reported with no birth defects. Cases of abnormalities after paternal exposure to ribavirin are lacking.
Also studies on the influence of ribavirin on sperm in human are lacking.
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.
In cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin elective termination of the pregnancy is usually recommended. However three cases of births after paternal exposure are reported with no birth defects. Cases of abnormalities after paternal exposure to ribavirin are lacking.
Also studies on the influence of ribavirin on sperm in human are lacking.
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: