Pharmacogenetic analysis study of hepatitis C patients treated with DEB025/Alisporivir alone or with Peg-IFN2a and/or Ribavirin

A Retrospective Pharmacogenetic Analysis of Hepatitis C Patients treated with Alisporivir (DEB025) Alone or in Combination with Peg-IFN2a and/or Ribavirin - NA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003559-21-DE

Enrollment

277

Registered

2011-12-12

Start date

2012-02-28

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C and how biomarkers affect the response to treatment of the disease MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: INN or Proposed INN: Alisporivir CAS Number: 254435-95-5 Current Sponsor code: DEB025

Eligibility

Sex/Gender

All

Inclusion criteria

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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: ;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 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 ;Timepoint(s) of evaluation of this end point: Retrospective pharmacogenetic analysis	—

Measure

Time frame

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.;Secondary Objective: ;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 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 ;Timepoint(s) of evaluation of this end point: Retrospective pharmacogenetic analysis

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Secondary

Measure	Time frame
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 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 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 4) To evaluate the durability of sustained virologic response by measuring HCV RNA in patients who completed DEB-025-HCV-205 5) To evaluate biochemical liver function of patients who completed DEB-025-HCV-205 to determine changes in liver disease over time;Timepoint(s) of evaluation of this end point: 1-3) Retrospective pharmacogenetic analysis 4-5) At the time of sample analysis	—

Measure

Time frame

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 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 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 4) To evaluate the durability of sustained virologic response by measuring HCV RNA in patients who completed DEB-025-HCV-205 5) To evaluate biochemical liver function of patients who completed DEB-025-HCV-205 to determine changes in liver disease over time;Timepoint(s) of evaluation of this end point: 1-3) Retrospective pharmacogenetic analysis 4-5) At the time of sample analysis

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Countries

Belgium, Canada, France, Germany, Italy, Poland, Romania, Spain

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026