Hepatitis CPhase 3NCT02753699

Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

A Phase 3 study testing Alisporivir in people with Hepatitis C, run by Debiopharm International SA at 119 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time. 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?: Alisporivir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 723 participants
Where: 119 sitesin 22 countries
Study dates: Dec 2011to May 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Who cannot join

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

Trial locations and contacts

119 sites in 22 countries.

Country

City, postcode or hospital

119 sites in 22 countries

Italy14 sites

Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Milan, MI, 20121
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Naples, 80135
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Torino, TO, 10126

Other trials in Italy

United States12 sites

Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Dallas, Texas, 75246-2096
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Indianapolis, Indiana, 46237
Novartis Investigative Site
La Jolla, California, 92037
Novartis Investigative Site
Salt Lake City, Utah, 84124
Novartis Investigative Site
San Antonio, Texas, 78215
Novartis Investigative Site
San Diego, California, 92101
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
Ventura, California, 93003

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Germany9 sites

Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24146
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mainz, 55131

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Taiwan9 sites

Novartis Investigative Site
Chiayi City, Taiwan, 600
Novartis Investigative Site
Douliu, 640
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Keelung, 20401
Novartis Investigative Site
Linkou District, 33305
Novartis Investigative Site
Niaosong Township, 83301
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 112

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Hungary8 sites

Novartis Investigative Site
Békéscsaba, H-5600
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1097
Novartis Investigative Site
Budapest, 1126
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Pécs, 7624
Novartis Investigative Site
Székesfehérvár, 8000

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United Kingdom8 sites

Novartis Investigative Site
Birmingham, B15 2TT
Novartis Investigative Site
Glasgow - Scotland, G12 OYN
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
London, SW17 0QT
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
Novartis Investigative Site
Nottingham, NG7 2UH
Novartis Investigative Site
Plymouth, PL6 8DH

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Romania7 sites

Novartis Investigative Site
Bucharest, 020125
Novartis Investigative Site
Bucharest, 021105
Novartis Investigative Site
Bucharest, 030317
Novartis Investigative Site
Bucharest, 050524
Novartis Investigative Site
Craiova, 200515
Novartis Investigative Site
Iași, 700506
Novartis Investigative Site
Iași

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South Korea7 sites

Novartis Investigative Site
Busan, Busan, 602-739
Novartis Investigative Site
Busan, 602-715
Novartis Investigative Site
Incheon, 22332
Novartis Investigative Site
Pusan, 614-735
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-712
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, 626-770

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Australia5 sites

Novartis Investigative Site
Fitzroy, Victoria, 3065
Novartis Investigative Site
Greenslopes, Queensland, 4120
Novartis Investigative Site
Kingswood, New South Wales, 2747
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Westmead, New South Wales, 2145

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France5 sites

Novartis Investigative Site
Clichy, 92110
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75014

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Poland5 sites

Novartis Investigative Site
Bialystok, 15-540
Novartis Investigative Site
Bydgoszcz, 85-030
Novartis Investigative Site
Lódz, 91-347
Novartis Investigative Site
Warsaw, 01-201
Novartis Investigative Site
Zawiercie, 42-400

Other trials in Poland

Spain5 sites

Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Majadahonda, Madrid, 28222
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Valencia, Valencia, 46014

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Canada4 sites

Novartis Investigative Site
Calgary, Alberta, T2N 4N1
Novartis Investigative Site
Torono, Ontario, M5G 2C4
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1J4
Novartis Investigative Site
Vancouver, British Columbia, v6z 2k5

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India4 sites

Novartis Investigative Site
Delhi, National Capital Territory of Delhi, 110070
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500012
Novartis Investigative Site
Ludhiana, Punjab, 141001
Novartis Investigative Site
Mumbai, Maharashtra, 400012

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Thailand4 sites

Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Khon Kaen, 40002
Novartis Investigative Site
Songkhla, 90110

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Vietnam3 sites

Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Hanoi
Novartis Investigative Site
Ho Chi Minh City

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Argentina2 sites

Novartis Investigative Site
Buenos Aires, Buenos Aires, C1125ABE
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1405BCK

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Mexico2 sites

Novartis Investigative Site
Mexico City, Mexico City, 14000
Novartis Investigative Site
Monterrey, Nuevo León, 64020

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Russia2 sites

Novartis Investigative Site
Moscow, 111123
Novartis Investigative Site
Saint Petersburg, 197376

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Turkey (Türkiye)2 sites

Novartis Investigative Site
Fatih / Istanbul, 34098
Novartis Investigative Site
Izmir, 35040

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Belgium1 site

Novartis Investigative Site
Ghent, 9000

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Hong Kong1 site

Novartis Investigative Site
Hong Kong, Hong Kong

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About this study

Official title: A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

Conditions: Hepatitis C
Being tested: Alisporivir
Keywords: Chronic hepatitis C
Medical subject headings: Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlisporivirDrug
Also called DEB025, Debio 025, ALV
Intervention of interest; follow-up after ALV-active study

Study groups in NCT02753699
Study group	Role	What they receive
From Study 2210	Experimental	All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. Receives: Drug: Alisporivir
From Study 2301	Experimental	All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. Receives: Drug: Alisporivir
From Study 2211	Experimental	All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. Receives: Drug: Alisporivir

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Measured: up to 120 Weeks

Secondary outcomes (1)

Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.
Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.
Measured: at Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011May 2015

First posted28 Apr 2016 (estimated)
Study startDec 2011
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis CStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 3
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 723 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753699
Sponsor's protocol ID: CDEB025A2312
Other IDs: 2011-006131-38
Status last verified: Jul 2016
First submitted: 16 Mar 2016
Last updated: 26 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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Elimination of Hepatitis C Virus Among Users of Substances
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients
ClinicalTrials.gov ID: NCT02753699
Acronym / sponsor ID: CDEB025A2312
Conditions: Hepatitis C
Keywords: Chronic hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 723 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Posted 26 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
From Study 2210	Experimental	Drug: AlisporivirAll participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
From Study 2301	Experimental	Drug: AlisporivirAll participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
From Study 2211	Experimental	Drug: AlisporivirAll participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Key exclusion criteria (3 listed)

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

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
AlisporivirAlso: DEB025, Debio 025, ALVIntervention of interest; follow-up after ALV-active study	Drug	From Study 2210, From Study 2211, From Study 2301

Primary outcome

Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Time frame: up to 120 Weeks

1 secondary outcome

Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.
Time frame: at Week 48

Results and safety

Results posted to the registry on 26 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
From Study 2210	164	150
From Study 2301	397	354
From Study 2211	162	139

Primary outcome: Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48

Time frame: up to 120 Weeks. Number. Unit: percentage of participants

Measure	From Study 2210 n = 161	From Study 2301 n = 383	From Study 2211 IFN-free n = 53	From Study 2211 Overall n = 160
Week 1 (n=152,371,53,152)	96.7	99.5	100.0	100.0
Week 24 (n=148,346,49,148)	100.0	100.0	98.0	99.3
Week 48 (n=146,337,46,140)	100.0	99.7	100.0	100.0
Week 96 (n=7,0,36,90)	100.0	0.0	100.0	100.0
Week 120 (n=0,0,1,3)	0.0	0.0	100.0	100.0
Overall (n=161,383,53,160)	96.9	99.2	98.1	99.4

Population analysed: Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
From Study 2210	7 of 164 (4.3%)	0 of 164 (0%)	Not reported
From Study 2301	8 of 397 (2%)	0 of 397 (0%)	Not reported
From Study 2211 IFN-free	1 of 54 (1.9%)	0 of 54 (0%)	Not reported
From Study 2211 Overall	3 of 162 (1.9%)	0 of 162 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

119 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alisporivir in people with Hepatitis C, run by Debiopharm International SA at 119 sites in 22 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 5 inclusion and 3 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in Italy, United States, Germany, Taiwan, Hungary and 17 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 (time frame: up to 120 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02753699.

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 Aug 2016.