Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period

Hepatitis C Clinical Trial

Official title:

Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531269
• Other study ID #: AI444-319
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: May 6, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: None
• Study type: Observational

Clinical Trial Summary

Using European data from patients included in the Named Patient Program (NPP) and from the early post-marketing authorization period, the present study aims to describe patient characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in Europe. This will be a retrospective cohort study of patients who received treatment with a DCV-based regimen in the following context:

• Patients enrolled within the European NPP in one of the following countries Austria, Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or

• In those countries where DCV is commercially available (ie, Sweden, Germany, United Kingdom), patients who received DCV during the early post-marketing authorization period

The results of this study will contribute to a better understanding of effectiveness of DCV-based regimens in a population that differs from population in the clinical trials, and therefore will provide additional valuable information to inform clinical practice.

This study intends to estimate primarily the effectiveness of DCV-based regimens as measured by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end of Hepatitis C virus (HCV).

This study intends also to describe as secondary objectives the characteristics (ie, demographic and clinical characteristics and treatment patterns of patients starting a new DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based regimens as measured by:

• On-treatment virological response at post treatment follow-up visit Week 4; and

• Virological response at the end of treatment (EOT); and

• The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post treatment follow-up visit Week 24 (SVR24); and

• The occurrence of virological failure (on-treatment and relapse).

An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the overall population treated with DCV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients participating in the DCV NPP from 7 European countries (Austria, Denmark, Italy, Sweden, Spain, Switzerland, and UK). The following patients were eligible to participate in the NPP

• The patient have a serious or life-threatening condition that is impacting life expectancy within 12 months.

• There are no comparable or satisfactory alternative treatments options exist for the patient, and/or currently available treatment options have been exhausted.

• The patient was ineligible to participate in a clinical trial, or there was no ongoing clinical trial in the patient´s country of residence to treat his/her HCV-infection.

• In countries where DCV is commercially available at time of study initiation(Sweden, UK, and Germany), patients treated with DCV during the early post-marketing authorization period.

• Patients initiating any DCV-based regimen during the inclusion periods.

• Recorded in one of the HCV data sources used for the study.

Exclusion Criteria:

• Patients included in the DCV Compassionate use program (CUP) (AI444-237 Protocol) open in 6 European countries (Germany, Austria, Sweden, Netherlands, Norway and UK) after Committee for Medicinal Products for Human Use (CHMP) opinion for the DCV CUP in Europe will be excluded since these patients will be analyzed as part of separate datasets.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Switzerland	Local Institution	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Basel Institute of Clinical Epidemiology (BICE)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	Effectiveness of DCV-based regimens as measured by the SVR12, overall and in specific patient sub-populations	Up to 36 months	No
Secondary	SVR4	Effectiveness of DCV-based regimens as measured by SVR4	Up to 36 months	No
Secondary	SVR24	Effectiveness of DCV-based regimens as measured by SVR24	Up to 36 months	No
Secondary	On-treatment Virological response at week 4 assessed by measuring viral load		Up to 36 months	No
Secondary	Virological response at the end of treatment (EOT) assessed by measuring viral load		Up to 36 months	No
Secondary	The occurrence of virological failure (on-treatment and relapse) assessed by measuring viral load	Virological failure is defined as virologic breakthrough, other on-treatment failure or relapse, where: Virologic breakthrough is defined as confirmed = 1 log10 IU/mL HCV RNA on treatment increase from nadir, or confirmed increase in HCV RNA = LLOQ if HCV RNA previously declined to < LLOQ (TD/TND). (LLOQ: Lower limit of quantification); Relapse is defined as HCV RNA < LLOQ (TND) at End of Treatment followed by confirmed detectable HCV RNA = LLOQ in any follow-up visit window.; On-treatment failure is defined as HCV RNA = LLOQ at any time point not meeting the definition of virologic breakthrough or relapse.	Up to 36 months	No

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