Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056862
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2003-03-25
Brief Title:
Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Low Dose Peginterferon and Ribavirin Therapy for Patients With Chronic Hepatitis C Infected With Genotype 2 or 3
Status:
COMPLETED
Status Verified Date:
2013-11
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:
This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that in some patients can progress to cirrhosis of the liver liver cancer and liver failure
Detailed Description:
Sixty patients with chronic hepatitis C infected with HCV genotype 2 or 3 will be treated using the combination of either low- or standard dose peginterferon and ribavirin for 24 weeks with re-treatment using the standard doses and a longer duration 48 weeks for those who do not respond to or relapse after initial low dose therapy
Adult patients with chronic hepatitis C who have HCV genotype 2 or 3 and previously have not received anti-viral treatment will be given peginterferon alfa-2a 90 or 180 micrograms weekly by injection and ribavirin 800 mg daily by mouth Patients will be monitored at 2- to 4-week intervals for side effects compliance complete blood counts liver biochemical tests and HCV RNA Patients becoming HCV RNA negative by week 12 will be considered on-treatment responders continue therapy to week 24 and be monitored thereafter for another 24 weeks Patients who do not become HCV RNA negative by week 12 as well as patients who relapse after therapy will be retreated with 180 micrograms of peginterferon weekly and 800 mg of ribavirin for another 48 weeks
The primary outcome will be sustained loss of HCV RNA at 24 weeks after low- or standard-dose combination therapy Secondary outcomes include viral kinetics and side effects Because of preliminary results in the initial 31 patients enrolled in this study the dose of peginterferon was changed from 90 to 180 micrograms weekly for the remaining 29 patients to be enrolled allowing for a direct comparison of efficacy viral kinetics and side effects of standard- vs low-dose peginterferon therapy
This study will evaluate the relative efficacy and safety of the standard versus lower doses of peginterferon with ribavirin in patients with chronic hepatitis C and HCV genotype 2 or 3
Adult patients with chronic hepatitis C who have HCV genotype 2 or 3 and previously have not received anti-viral treatment will be given peginterferon alfa-2a 90 or 180 micrograms weekly by injection and ribavirin 800 mg daily by mouth Patients will be monitored at 2- to 4-week intervals for side effects compliance complete blood counts liver biochemical tests and HCV RNA Patients becoming HCV RNA negative by week 12 will be considered on-treatment responders continue therapy to week 24 and be monitored thereafter for another 24 weeks Patients who do not become HCV RNA negative by week 12 as well as patients who relapse after therapy will be retreated with 180 micrograms of peginterferon weekly and 800 mg of ribavirin for another 48 weeks
The primary outcome will be sustained loss of HCV RNA at 24 weeks after low- or standard-dose combination therapy Secondary outcomes include viral kinetics and side effects Because of preliminary results in the initial 31 patients enrolled in this study the dose of peginterferon was changed from 90 to 180 micrograms weekly for the remaining 29 patients to be enrolled allowing for a direct comparison of efficacy viral kinetics and side effects of standard- vs low-dose peginterferon therapy
This study will evaluate the relative efficacy and safety of the standard versus lower doses of peginterferon with ribavirin in patients with chronic hepatitis C and HCV genotype 2 or 3
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 |
|---|---|---|---|
| 03-DK-0136 | OTHER | NIH Clinical Center | None |