Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01567540
Status:
TERMINATED
Last Update Posted:
2014-01-20
First Post:
2012-03-02
Brief Title:
A Pilot Study Evaluating Safety of Sitagliptin Combined With Peg-IFN Alfa-2a Ribavirin in Chronic Hepatitis C Patients
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
A Pilot Study to Evaluate the Clinical and Biological Tolerance of Sitagliptin With Pegylated Interferon alfa2a Plus Ribavirin Combination Therapy in Chronic Hepatitis C Patients
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New treatments available which prevents additional recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatitis C infection is a major public health problem with nearly 175 million infected individuals worldwide Although cure is possible only 20-40 of patients spontaneously resolve infection and 40-80 of chronically infected patients numbers vary depending on viral genotype that receive pegylated-interferon-alfa2aribavirin therapy clear the virus and are sustained virologic responders SVR Still for many the virus manages to circumvent natural immunity and current therapeutic strategies resulting in significant morbidity and mortality
To better define the distinct clinical outcomes of HCV infection many investigators have performed candidate molecules screens or transcriptional profiling in order to identify correlates of viral clearance One molecule that has gained significant attention is CXCL10 also known as interferon-gamma induced protein-10 or IP-10 as an important negative prognostic biomarker Given that CXCL10 is produced by hepatocytes and mediates chemo-attraction of activated lymphocytes expressing the CXCL10-receptor CXCR3 it is counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness
The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in situ resulting in the generation of an antagonist form of the chemokine Based on the use of specific inhibitors the investigators now propose to test whether protection of the agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 ribavirin therapy This can be achieved using DPPIV inhibitors targeting the enzyme responsible for N-terminal truncation of CXCL10 If safety is confirmed the efficacy of DPPIV-inhibition in HCV patients will be tested in future trials that examine potential clearance benefits
To better define the distinct clinical outcomes of HCV infection many investigators have performed candidate molecules screens or transcriptional profiling in order to identify correlates of viral clearance One molecule that has gained significant attention is CXCL10 also known as interferon-gamma induced protein-10 or IP-10 as an important negative prognostic biomarker Given that CXCL10 is produced by hepatocytes and mediates chemo-attraction of activated lymphocytes expressing the CXCL10-receptor CXCR3 it is counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness
The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in situ resulting in the generation of an antagonist form of the chemokine Based on the use of specific inhibitors the investigators now propose to test whether protection of the agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 ribavirin therapy This can be achieved using DPPIV inhibitors targeting the enzyme responsible for N-terminal truncation of CXCL10 If safety is confirmed the efficacy of DPPIV-inhibition in HCV patients will be tested in future trials that examine potential clearance benefits
Detailed Description:
None
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 |
|---|---|---|---|
| 2011-000823-34 | EUDRACT_NUMBER | None | None |