Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001317
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Status:
COMPLETED
Status Verified Date:
2000-05
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:
None
Brief Summary:
In a recent double-blinded placebo-controlled multi-center international study subcutaneous injections of interferon-gamma administered three times weekly reduced the frequency of serious infections in patients with chronic granulomatous disease Patients receiving interferon-gamma had fewer hospital stays shorter in length than the placebo group Children less than 10 years of age benefitted most from treatment and had fewer side effects
Based on these data the FDA licensed interferon-gamma for prophylaxis in CGD patients We wish to monitor our patients who participated in the original study for possible long-term side effects Any new patients referred to us who are either on interferon-gamma or considered to be candidates for interferon-gamma will be considered for this protocol In addition our patients who were originally accepted under Genentechs compassionate plea protocol will also be monitored under this new protocol The patients will be evaluated every six months with blood work and interim medical histories taken
Based on these data the FDA licensed interferon-gamma for prophylaxis in CGD patients We wish to monitor our patients who participated in the original study for possible long-term side effects Any new patients referred to us who are either on interferon-gamma or considered to be candidates for interferon-gamma will be considered for this protocol In addition our patients who were originally accepted under Genentechs compassionate plea protocol will also be monitored under this new protocol The patients will be evaluated every six months with blood work and interim medical histories taken
Detailed Description:
In a recent double-blinded placebo-controlled multi-center international study subcutaneous injections of interferon-gamma administered three times weekly reduced the frequency of serious infections in patients with chronic granulomatous disease Patients receiving interferon-gamma had fewer hospital stays shorter in length than the placebo group Children less than 10 years of age benefitted most from treatment and had fewer side effects
Based on these data the FDA licensed interferon-gamma for prophylaxis in CGD patients We wish to monitor our patients who participated in the original study for possible long-term side effects Any new patients referred to us who are either on interferon-gamma or considered to be candidates for interferon-gamma will be considered for this protocol In addition our patients who were originally accepted under Genentechs compassionate plea protocol will also be monitored under this new protocol The patients will be evaluated every six months with blood work and interim medical histories taken
Based on these data the FDA licensed interferon-gamma for prophylaxis in CGD patients We wish to monitor our patients who participated in the original study for possible long-term side effects Any new patients referred to us who are either on interferon-gamma or considered to be candidates for interferon-gamma will be considered for this protocol In addition our patients who were originally accepted under Genentechs compassionate plea protocol will also be monitored under this new protocol The patients will be evaluated every six months with blood work and interim medical histories taken
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-I-0186 | None | None | None |