Chronic Hepatitis CNCT02161939
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
A study testing Daclatasvir (BMS-790052) and Sofosbuvir in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 20 sites in United States.
Trial summary
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have… 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 (BMS-790052) and Sofosbuvir
- How many people
- Not given
- Where
- 20 sitesUnited States
- 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
- Subjects who received a liver transplant, have chronic hepatitis C virus (HCV) recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis
- Subjects with decompensated cirrhosis defined by Child-Pugh Class C
Who cannot join
- Patients who are <18 years old
- Clinical or pathologic evidence of acute ongoing liver graft rejection
- Creatinine clearance (CrCl) ≤30 mL/min (as estimated by Cockcroft and Gault formula)
- Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
- Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Piedmont Transplant
Atlanta, Georgia, 30309
Mercy Medical Center, Inc.
Baltimore, Maryland, 21202
Mass General
Boston, Massachusetts, 02114
UNC
Chapel Hill, North Carolina, 27599
Carolinas Healthcare Institute
Charlotte, North Carolina, 28204
Henry Ford
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32610
Research Specialist of Texas
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
USC - Keck Medical Center
Los Angeles, California, 90033
Yale University School of Medicine
New Haven, Connecticut, 06520
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Weill Cornell Medical College
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadephia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
Virginia Commonwealth University
Richmond, Virginia, 23298
Swedish Hospital
Seattle, Washington, 98122
Montefiore Medical Center
The Bronx, New York, 10467
University of Massachusetts Memorial Medical Center, University Campus
Worchester, Massachusetts, 01655
About this study
Official title: A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data
- Conditions
- Chronic Hepatitis C
- Being tested
- Daclatasvir (BMS-790052), Sofosbuvir
- 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.
Daclatasvir (BMS-790052)Drug
SofosbuvirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT02161939
- Sponsor's protocol ID
- AI444-257
- Status last verified
- Jan 2016
- First submitted
- 10 Jun 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence
- ClinicalTrials.gov ID
- NCT02161939
- Acronym / sponsor ID
- AI444-257
- Conditions
- Chronic Hepatitis C
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 12 Jun 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 DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients chronically infected with Hepatitis C
- Subjects who received a liver transplant, have chronic hepatitis C virus (HCV) recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis
- Subjects with decompensated cirrhosis defined by Child-Pugh Class C
Key exclusion criteria (5 listed)
- Patients who are <18 years old
- Clinical or pathologic evidence of acute ongoing liver graft rejection
- Creatinine clearance (CrCl) ≤30 mL/min (as estimated by Cockcroft and Gault formula)
- Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
- 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 |
|---|---|---|
| Daclatasvir (BMS-790052) | Drug | – |
| Sofosbuvir | 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 29 Jan 2016.
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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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daclatasvir (BMS-790052) and Sofosbuvir in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 20 sites in United States.
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 3 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 29 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 20 sites in United States. 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?
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 29 Jan 2016.