No longer availableNCT02097966Updated Jan 27, 2016

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

An expanded access record providing Daclatasvir and Sofosbuvir in Chronic Hepatitis C, sponsored by Bristol-Myers Squibb. No longer available at 58 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by Bristol-Myers Squibb · Expanded access

Study type: Expanded access
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Chronic Hepatitis C

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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

Browse Hepatitis A studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All

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

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

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

Access details

Study type: Expanded access

Available treatment

DrugDaclatasvir
Also known as: BMS-790052
DrugSofosbuvir
DrugRibavirin

Where to request access

58 sites

Local Institution
Amstetten, Austria
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Braunua/Inn, Austria
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Graz, Austria
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Innsbruck, Austria
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Linz, Austria
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Oberndorf, Austria
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Oberpullendorf, Austria
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Salzburg, Austria
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Vienna, Austria
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Wien, Austria
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Aachen, Germany
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Augsburg, Germany
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Berlin, Germany
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Bonn, Germany
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Cologne, Germany
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Essen, Germany
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Frankfurt Am Main, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hannover, Germany
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Heidelberg, Germany
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Herne, Germany
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Jena, Germany
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Kiel, Germany
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Leipzig, Germany
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Muenchen, Germany
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Muenster, Germany
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Munchen, Germany
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Stuttgart, Germany
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Tuebingen, Germany
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Ulm, Germany
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Wuerzburg, Germany
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Amsterdam, Netherlands
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Rotterdam, Netherlands
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Urecht, Netherlands
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Falun, Sweden
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Gothenburg, Sweden
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Helsingborg, Sweden
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Kalmar, SE-391 85, Sweden
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Lulea, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Plymouth, Devon, United Kingdom
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Liverpool, Merseyside L7 8XP, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Oxford, Oxfordshire, United Kingdom
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Newcastle Upon Tyne, Tyne And Wear, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Leeds, Yorkshire, United Kingdom
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Brighton, United Kingdom
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Cardiff, United Kingdom
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Frimley, United Kingdom
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Guildford, United Kingdom
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London, United Kingdom
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Wrexham, United Kingdom

References and documents

Publications

Rockstroh JK, Ingiliz P, Petersen J, Peck-Radosavljevic M, Welzel TM, Van der Valk M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease. Antivir Ther. 2017;22(3):225-236. doi: 10.3851/IMP3108. Epub 2016 Nov 15. PubMed 27845298 ↗
Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, Berg T, Spengler U, Weiland O, van der Valk M, Rockstroh J, Peck-Radosavljevic M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016 Nov;65(11):1861-1870. doi: 10.1136/gutjnl-2016-312444. Epub 2016 Sep 7. Erratum In: Gut. 2016 Dec;65(12):2060. doi: 10.1136/gutjnl-2016-312444corr1. PubMed 27605539 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02097966
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Mar 27, 2014
Last update: Jan 27, 2016

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

View the source record on ClinicalTrials.gov ↗

Requesting access

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No contact was published for this record. The registry link below has the sponsor’s details.

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