Pharmacogenetic analysis study of hepatitis C patients treated with DEB025/Alisporivir alone or with Peg-IFN2a and/or Ribaviri
Phase 1
- Conditions
- Hepatitis C and how biomarkers affect the response to treatment of the diseaseMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-003559-21-ES
- Lead Sponsor
- ovartis Farmaceutica S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
Patients must have completed studies DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205. Written informed consent must be obtained prior to any assessments being performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 177
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Timepoint(s) of evaluation of this end point: Retrospective pharmacogenetic analysis;Main Objective: To assess the impact of potential markers (or polymorphisms) in host genes from patients in studies DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205 on the PK profile, safety, and efficacy of alisporivir alone or in combination with peg-IFN-2a and ribavirin. These potential markers may include variants in cytochrome P450 isoenzymes 2D6 and 3A5, transporters such as P-gp, UGT1A1, cyclophilin A and B, IL28B, among others.;Primary end point(s): 1) To examine the association of individual genetic variation on early viral response after 2 and 4 weeks of alisporivir monotherapy in DEB-025-103 and DEB-025-HCV-203, respectively<br><br>2) To examine the association of individual genetic variation on SVR rate in patients treated with alisporivir in combination with Peg-IFN-2a and ribavirin for 24 or 48 weeks in DEB-025-205
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1-3) Retrospective pharmacogenetic analysis<br>4-5) At the time of sample analysis;Secondary end point(s): 1)To examine the association of individual genetic variation on RVR, viral response at Week 12 and end of treatment response in patients treated with alisporivir in combination with Peg-IFN-2a and ribavirin in DEB-025-205<br><br>2)To examine the association of individual genetic variation on elevation of on-treatment bilirubin level in DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205<br><br>3)To examine the association of individual genetic variation on pharmacokinetic property of alisporivir in DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205<br><br>4) To evaluate the durability of sustained virologic response by measuring HCV RNA in patients who completed DEB-025-HCV-205 <br>5) To evaluate biochemical liver function of patients who completed DEB-025-HCV-205 to determine changes in liver disease over time