Hepatitis CNCT01525810
Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 75 sites in 19 countries.
Trial summary
The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Peginterferon Lambda-1a (BMS-914143)
- How many people
- 218 participants
- Where
- 75 sitesin 19 countries
- Study dates
- Mar 2012to Nov 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who participated in a clinical trial in which BMS-914143 was administered for the treatment of chronic hepatitis C
Who may be able to join
- Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) < LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA <LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study
Who cannot join
- Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda
Trial locations and contacts
75 sites in 19 countries.
75 sites in 19 countries
United States17 sites
Metropolitan Research
Annandale, Virginia, 22003
Texas Clinical Research Institute
Arlington, Texas, 76012
Consultants For Clinical Research
Cincinnati, Ohio, 45249
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
The Queen'S Medical Center
Honolulu, Hawaii, 96813
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, 77030
University Of Texas Health Science Center At Houston
Houston, Texas, 77030
Va Medical Center (151)
Houston, Texas, 77030
Scripps Clinic
La Jolla, California, 92037
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, 30060
Clinical Research Centers Of America
Murray, Utah, 84123
Yale University School Of Medicine
New Haven, Connecticut, 06510
Orlando Immunology Center
Orlando, Florida, 32803
Mayo Clinic
Rochester, Minnesota, 55905
Texas Liver Institute
San Antonio, Texas, 78215
Virginia Mason Medical Center
Seattle, Washington, 98101
Australia13 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Camperdown, New South Wales, 2050
Local Institution
Darlinghurst, New South Wales, 2010
Local Institution
Fitzroy, Victoria, 3065 VIC
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Herston, Queensland, 4029
Local Institution
Melbourne, Victoria, 3004
Local Institution
Parkville, Victoria, 3050
Local Institution
Randwick, New South Wales, 2031
Local Institution
Sydney, New South Wales, 2139
Local Institution
Westmead, New South Wales, 2145
Local Institution
Woolloongabba, Queensland, 4102
France7 sites
Local Institution
Clichy, 92118
Local Institution
Créteil, 9410
Local Institution
Montpellier, 34295
Local Institution
Nice, 06202
Local Institution
Paris, 75571
Local Institution
Paris, 75679
Local Institution
Pessac, 33604
Italy7 sites
Local Institution
Cisanello (pisa), 56124
Local Institution
Florence, 50134
Local Institution
Milan, 20122
Local Institution
Milan, 20142
Local Institution
Naples, 80131
Local Institution
Novara, 28100
Local Institution
Viale Del Policlinico, 155, 00161
Argentina6 sites
Local Institution
Buenos Aires, Buenos Aires, 1119
Local Institution
Buenos Aires, Buenos Aires, 1121
Local Institution
Buenos Aires, Buenos Aires, 1181
Local Institution
Buenos Aires, 1221
Local Institution
Mar del Plata, Buenos Aires, 7600
Local Institution
Rosario, Santa Fe Province, 2000
Romania4 sites
Local Institution
Bucharest, 30303
Local Institution
Bucharest, 50524
Local Institution
Iași, 700506
Local Institution
Timișoara, 300 002
Poland3 sites
Local Institution
Bialystok, 15-540
Local Institution
Krakow, 31-202
Local Institution
Wroclaw, 50-220
Spain3 sites
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08035
Local Institution
Valencia, 46010
Germany2 sites
Local Institution
Hamburg, 20246
Local Institution
Heidelberg, 69120
Greece2 sites
Local Institution
Athens, 10676
Local Institution
Thessaloniki, 54006
Netherlands2 sites
Local Institution
Amsterdam, 1105 AZ
Local Institution
Leiden, 2333 ZA
Canada1 site
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7
About this study
Official title: A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C
The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response
- Conditions
- Hepatitis C
- Being tested
- Peginterferon Lambda-1a (BMS-914143)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Lambda-1a (BMS-914143)Drug
Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)]
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with Peginterferon Lambda-1a (BMS-914143) | Subjects who participated in a clinical trial in which Peginterferon Lambda-1a (BMS-914143) was administered for the treatment of chronic hepatitis C Receives: Drug: Peginterferon Lambda-1a (BMS-914143) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of virologic response (time to loss of virologic response)
Durability of virologic response as assessed by the time to loss of virologic response in subjects treated in a previous study with BMS-914143 who have HCV RNA less than the limit of quantitation of the assay (< LOQ) at the completion of the required post-treatment follow-up in the previous study. Loss of virologic response assessed using HCV RNA at 24-week intervals
Measured: 24 week intervals from end of treatment in parent study up to 144 weeks
Secondary outcomes (2)
Long-term progression of liver disease
Long-term progression of liver disease as measured by laboratory indicators of hepatic status and function, all-cause mortality and liver related mortality in subjects previously treated with BMS-914143 who have HCV RNA < LOQ at the completion of the required post-treatment follow-up in the parent study
Measured: 24 week intervals up to 144 weeks
Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study
Measured: 24 week intervals up to 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
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
- NCT01525810
- Sponsor's protocol ID
- AI452-016
- Other IDs
- 2011-005293-31
- Status last verified
- Mar 2015
- First submitted
- 11 Jan 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01525810
- Acronym / sponsor ID
- AI452-016
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 Feb 2012 (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 purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with Peginterferon Lambda-1a (BMS-914143) | – | Drug: Peginterferon Lambda-1a (BMS-914143)Subjects who participated in a clinical trial in which Peginterferon Lambda-1a (BMS-914143) was administered for the treatment of chronic hepatitis C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who participated in a clinical trial in which BMS-914143 was administered for the treatment of chronic hepatitis C
Key inclusion criteria (1 listed)
- Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) < LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA <LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study
Key exclusion criteria (1 listed)
- Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda
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 |
|---|---|---|
| Peginterferon Lambda-1a (BMS-914143)Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)] | Drug | Subjects treated with Peginterferon Lambda-1a (BMS-914143) |
Primary outcome
Durability of virologic response (time to loss of virologic response)
Time frame: 24 week intervals from end of treatment in parent study up to 144 weeks
Durability of virologic response as assessed by the time to loss of virologic response in subjects treated in a previous study with BMS-914143 who have HCV RNA less than the limit of quantitation of the assay (< LOQ) at the completion of the required post-treatment follow-up in the previous study. Loss of virologic response assessed using HCV RNA at 24-week intervals
2 secondary outcomes
Long-term progression of liver disease
Time frame: 24 week intervals up to 144 weeks
Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study
Time frame: 24 week intervals up to 144 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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
75 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 75 sites in 19 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Australia, France, Italy, Argentina and 14 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Durability of virologic response (time to loss of virologic response) (time frame: 24 week intervals from end of treatment in parent study up to 144 weeks). It is what the study was designed to measure, not a finding.
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 26 Mar 2015.