Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351403
Status:
COMPLETED
Last Update Posted:
2010-02-08
First Post:
2006-07-11
Brief Title:
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Sponsor:
FGK Clinical Research GmbH
Organization:
FGK Clinical Research GmbH
Study Overview
Official Title:
Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA
Status:
COMPLETED
Status Verified Date:
2010-02
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:
None
Brief Summary:
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks For some patients this might be too long for others too short An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity
The primary objective is to compare the cumulative rate of the sustained viral response SVR of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy
The primary objective is to compare the cumulative rate of the sustained viral response SVR of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy
Detailed Description:
Further objectives of this trial are
To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates
To evaluate the biochemical response to the treatment ALT values during and after the therapy in comparison to the virological response to the treatment
To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IUml
To evaluate the impact of the HCV RNA concentration before the therapy and the HCV kinetic during the therapy on the response to the treatment in the different groups
To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight
To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates
To evaluate the biochemical response to the treatment ALT values during and after the therapy in comparison to the virological response to the treatment
To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IUml
To evaluate the impact of the HCV RNA concentration before the therapy and the HCV kinetic during the therapy on the response to the treatment in the different groups
To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight
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 |
|---|---|---|---|
| 2006-000358-38 | EUDRACT_NUMBER | None | None |