Chronic Hepatitis CNCT02097966
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
A study testing Daclatasvir, Sofosbuvir and Ribavirin in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 56 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Daclatasvir, Sofosbuvir and Ribavirin
- How many people
- Not given
- Where
- 56 sitesin 5 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
56 sites in 5 countries.
56 sites in 5 countries
Germany21 sites
Local Institution
Aachen
Local Institution
Augsburg
Local Institution
Berlin
Local Institution
Bonn
Local Institution
Cologne
Local Institution
Essen
Local Institution
Frankfurt
Local Institution
Frankfurt am Main
Local Institution
Hamburg
Local Institution
Hanover
Local Institution
Heidelberg
Local Institution
Herne
Local Institution
Jena
Local Institution
Kiel
Local Institution
Leipzig
Local Institution
München
Local Institution
Münster
Local Institution
Stuttgart
Local Institution
Tübingen
Local Institution
Ulm
Local Institution
Würzburg
United Kingdom15 sites
Local Institution
Birmingham, West Midlands
Local Institution
Brighton
Local Institution
Cardiff
Local Institution
Frimley
Local Institution
Guildford
Local Institution
Leeds, Yorkshire
Local Instituition
Liverpool, Merseyside, L7 8XP
Local Institution
London, Greater London
Local Institution
London
Local Institution
Manchester, Greater Manchester
Local Institution
Newcastle upon Tyne, Tyne and Wear
Local Institution
Nottingham, Nottinghamshire
Local Institution
Oxford, Oxfordshire
Local Institution
Plymouth, Devon
Local Institution
Wrexham
Austria9 sites
Local Institution
Amstetten
Local Institution
Braunua/Inn
Local Institution
Graz
Local Institution
Innsbruck
Local Institution
Linz
Local Institution
Oberndorf
Local Institution
Oberpullendorf
Local Institution
Salzburg
Local Institution
Vienna
Sweden8 sites
Local Institution
Falun
Local Institution
Gothenburg
Local Institution
Helsingborg
Local Institution
Kalmar, SE-391 85
Local Institution
Luleå
Local Institution
Lund
Local Institution
Stockholm
Local Institution
Sundsvall
Netherlands3 sites
Local Institution
Amsterdam
Local Institution
Rotterdam
Local Institution
Urecht
About this study
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
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
- Chronic Hepatitis C
- Being tested
- Daclatasvir, Sofosbuvir, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclatasvirDrug
Also called BMS-790052
SofosbuvirDrug
RibavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097966
- Sponsor's protocol ID
- AI444-237
- Status last verified
- Nov 2015
- First submitted
- 25 Mar 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
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 27845298Welzel 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.
PubMed 27605539
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02097966
- Acronym / sponsor ID
- AI444-237
- Conditions
- Chronic Hepatitis C
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaclatasvirAlso: BMS-790052 | Drug | – |
| Sofosbuvir | Drug | – |
| Ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 27845298Rockstroh 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.
- Derived from this study: PubMed 27605539Welzel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
56 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daclatasvir, Sofosbuvir and Ribavirin in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 56 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Germany, United Kingdom, Austria, Sweden, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.