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NCT02097966 Clinical Trial

EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:
A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02097966
Other study ID # AI444-237
Secondary ID
Status No longer available
Phase N/A
First received March 25, 2014
Last updated January 26, 2016

Study information
Verified date November 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencySweden: Medical Products AgencyAustria: Agency for Health and Food SafetyNetherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Expanded Access

Clinical Trial Summary

The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Patients chronically infected with Hepatitis C

- Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options

Exclusion Criteria:

- Patients who are <18 years old

- Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)

- Patients who are pregnant

- Creatinine clearance (CrCl) = 30 mL/min (as estimated by Cockcroft and Gault formula)

- Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Daclatasvir

• Sofosbuvir

• Ribavirin

Locations
Country Name City State
Austria Local Institution Amstetten
Austria Local Institution Braunua/Inn
Austria Local Institution Graz
Austria Local Institution Innsbruck
Austria Local Institution Linz
Austria Local Institution Oberndorf
Austria Local Institution Oberpullendorf
Austria Local Institution Salzburg
Austria Local Institution Vienna
Austria Local Institution Wien
Germany Local Institution Aachen
Germany Local Institution Augsburg
Germany Local Institution Berlin
Germany Local Institution Bonn
Germany Local Institution Cologne
Germany Local Institution Essen
Germany Local Institution Frankfurt
Germany Local Institution Frankfurt Am Main
Germany Local Institution Hamburg
Germany Local Institution Hannover
Germany Local Institution Heidelberg
Germany Local Institution Herne
Germany Local Institution Jena
Germany Local Institution Kiel
Germany Local Institution Leipzig
Germany Local Institution Muenchen
Germany Local Institution Muenster
Germany Local Institution Munchen
Germany Local Institution Stuttgart
Germany Local Institution Tuebingen
Germany Local Institution Ulm
Germany Local Institution Wuerzburg
Netherlands Local Institution Amsterdam
Netherlands Local Institution Rotterdam
Netherlands Local Institution Urecht
Sweden Local Institution Falun
Sweden Local Institution Gothenburg
Sweden Local Institution Helsingborg
Sweden Local Institution Kalmar
Sweden Local Institution Lulea
Sweden Local Institution Lund
Sweden Local Institution Stockholm
Sweden Local Institution Sundsvall
United Kingdom Local Institution Birmingham West Midlands
United Kingdom Local Institution Brighton
United Kingdom Local Institution Cardiff
United Kingdom Local Institution Frimley
United Kingdom Local Institution Guildford
United Kingdom Local Institution Leeds Yorkshire
United Kingdom Local Instituition Liverpool Merseyside
United Kingdom Local Institution London Greater London
United Kingdom Local Institution London
United Kingdom Local Institution Manchester Greater Manchester
United Kingdom Local Institution Newcastle Upon Tyne Tyne And Wear
United Kingdom Local Institution Nottingham Nottinghamshire
United Kingdom Local Institution Oxford Oxfordshire
United Kingdom Local Institution Plymouth Devon
United Kingdom Local Institution Wrexham

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Sweden,  United Kingdom, 

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