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

NCT02531269 | Completed

• 1 other identifier: AI444-319
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• SVR12

  Effectiveness of DCV-based regimens as measured by the SVR12, overall and in specific patient sub-populations

  Up to 36 months

Secondary Outcomes (5)

• SVR4

  Up to 36 months

• SVR24

  Up to 36 months

• On-treatment Virological response at week 4 assessed by measuring viral load

  Up to 36 months

• Virological response at the end of treatment (EOT) assessed by measuring viral load

  Up to 36 months

• The occurrence of virological failure (on-treatment and relapse) assessed by measuring viral load

  Up to 36 months

Study Arms (4)

Patients treated with DCV (NPP)+Sofosbuvir +/- Ribavirin (RBV)

Patients treated with DCV (NPP) + Simeprevir +/- RBV

Patients treated with DCV(post-marketing) + Sofosbuvir +/- RBV

Patients treated with DCV(post-marketing) + Simeprevir +/- RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was selected from European HCV registries or databases in specific health-care facilities from Austria, Denmark, Italy, Sweden, Spain, Switzerland, and United Kingdom (UK)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Basel Institute of Clinical Epidemiology (BICE): collaborator

Study Sites (1)

Local Institution

Basel, Switzerland

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 24, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

CH (1)