Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006164
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2000-08-08
Brief Title:
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial HALT-C
Status:
COMPLETED
Status Verified Date:
2020-04
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:
HALT-C
Brief Summary:
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored randomized clinical trial of long-term use of Peginterferon alfa-2a pegylated interferon in patients who failed to respond to prior interferon treatment All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 35 years Patients in both arms of this study will be followed closely with quarterly study visits
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus prevent progression to cirrhosis prevent liver cancer and reduce the need for liver transplantation
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 35 years Patients in both arms of this study will be followed closely with quarterly study visits
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus prevent progression to cirrhosis prevent liver cancer and reduce the need for liver transplantation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| N01-DK-9-2328 | OTHER_GRANT | None | None |
| N01-DK-9-2323 | OTHER_GRANT | None | None |
| N01-DK-9-2324 | OTHER_GRANT | None | None |
| N01-DK-9-2325 | OTHER_GRANT | None | None |
| N01-DK-9-2326 | OTHER_GRANT | None | None |
| N01-DK-9-2321 | OTHER_GRANT | None | None |
| N01-DK-9-2327 | OTHER_GRANT | None | None |
| N01-DK-9-2319 | OTHER_GRANT | None | None |
| N01-DK-9-2318 | OTHER_GRANT | None | None |
| N01-DK-9-2320 | OTHER_GRANT | None | None |
| N01-DK-9-2322 | OTHER_GRANT | NIH NIDDK Contract | None |