Hepatitis C, ChronicPhase 3NCT02465203

3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

A Phase 3 study testing Previous treatment in DEB025 study in people with Hepatitis C, Chronic, run by Novartis Pharmaceuticals at 40 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Previous treatment in DEB025 study
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 40 sitesin 16 countries
Study dates: 6 Sep 2012to 23 Jan 2014
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

Males or females aged ≥18
Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
Have not achieved SVR24

Who cannot join

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Trial locations and contacts

40 sites in 16 countries.

Country

City, postcode or hospital

40 sites in 16 countries

United States7 sites

Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Houston, Texas, 77030
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

Other trials in United States

Germany6 sites

Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24146

Other trials in Germany

Romania5 sites

Novartis Investigative Site
Bucharest, District 1, 050524
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, 020125
Novartis Investigative Site
Bucharest, 021105
Novartis Investigative Site
Iași, 700506

Other trials in Romania

Taiwan5 sites

Novartis Investigative Site
Douliu, 640
Novartis Investigative Site
Kaohsiung City, 80756
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Linkou District, 33305
Novartis Investigative Site
Taichung, 40447

Other trials in Taiwan

Italy4 sites

Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Torino, TO, 10126

Other trials in Italy

Poland2 sites

Novartis Investigative Site
Bialystok, 15-540
Novartis Investigative Site
Warsaw, 01-201

Other trials in Poland

South Korea2 sites

Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Pusan, 614-735

Other trials in South Korea

Australia1 site

Novartis Investigative Site
Westmead, New South Wales, 2145

Other trials in Australia

Belgium1 site

Novartis Investigative Site
Leuven, 3000

Other trials in Belgium

Canada1 site

Novartis Investigative Site
Torono, Ontario, M5G 2C4

Other trials in Canada

Hungary1 site

Novartis Investigative Site
Budapest, 1097

Other trials in Hungary

India1 site

Novartis Investigative Site
Mumbai, Maharashtra, 400 036

Other trials in India

Puerto Rico1 site

Novartis Investigative Site
San Juan, 00909

Other trials in Puerto Rico

Spain1 site

Novartis Investigative Site
Barcelona, Catalonia, 08035

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Thailand1 site

Novartis Investigative Site
Songkhla, 90110

Other trials in Thailand

Vietnam1 site

Novartis Investigative Site
Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Patients

Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

Read the detailed description

The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.

Conditions: Hepatitis C, Chronic
Being tested: Previous treatment in DEB025 study
Keywords: Hepatitis C, chronic
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.

Previous treatment in DEB025 studyDrug
Also called Data was not collected
Follow-up after DEB025 active study

Study groups in NCT02465203
Study group	Role	What they receive
Follow up from feeder studies	Other	Follow up arm Receives: Drug: Previous treatment in DEB025 study

What is being measured

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

HCV RNA Sequencing
Persistence of resistance associated variants
Measured: 27 months

Secondary outcomes (4)

Safety Parameters as Measured by HCV RNA Sequencing
Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Measured: 27 months
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters
Changes in liver function and disease over time
Measured: 27 months
Safety Parameters as Measured by Liver UltraSound and Lab Parameters
Development of hepatocellular carcinoma (HCC)
Measured: 27 months
Safety Parameters
Safety over time of previous alisporivir exposure
Measured: 27 months

Timeline

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

6 Sep 201223 Jan 2014

First posted8 Jun 2015 (estimated)
Study start6 Sep 2012
Primary completion23 Jan 2014
Study completion23 Jan 2014

Why it stopped: Study was prematurely terminated.

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 C, ChronicStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02465203
Sponsor's protocol ID: CDEB025A2313
Other IDs: 2011-006132-24
Status last verified: Dec 2017
First submitted: 17 Mar 2015
Last updated: 12 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: terminated

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Patients
ClinicalTrials.gov ID: NCT02465203
Acronym / sponsor ID: CDEB025A2313
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was prematurely terminated.
Enrolment: 105 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 6 Sep 2012 (actual)
Primary completion: 23 Jan 2014 (actual)
Study completion: 23 Jan 2014 (actual)
First posted: 8 Jun 2015 (estimated)
Results: Posted 12 Jan 2018

Clinical summary

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

Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Follow up from feeder studies	Other	Drug: Previous treatment in DEB025 studyFollow up arm

Who may qualify

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

Key inclusion criteria (3 listed)

Males or females aged ≥18
Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
Have not achieved SVR24

Key exclusion criteria (2 listed)

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

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
Previous treatment in DEB025 studyAlso: Data was not collectedFollow-up after DEB025 active study	Drug	Follow up from feeder studies

Primary outcome

HCV RNA Sequencing
Time frame: 27 months
Persistence of resistance associated variants

4 secondary outcomes

Safety Parameters as Measured by HCV RNA Sequencing
Time frame: 27 months
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters
Time frame: 27 months
Safety Parameters as Measured by Liver UltraSound and Lab Parameters
Time frame: 27 months
Safety Parameters
Time frame: 27 months

Results and safety

Results posted to the registry on 12 Jan 2018, 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 (N=56)	56	0
From Study 2301 (N=36)	36	0
From Study 2211 - Overall (N=13)	13	0

Primary outcome: HCV RNA Sequencing

Time frame: 27 months. Number. Unit: Number of particiants

Measure	All Arms n = 105
Value	4

Population analysed: There was no hypothesis testing in this study, as the study was prematurely terminated. 4 patients with resistance associated variants have been identified at study start. Study was not powered for 105 participants

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A2210	3 of 53 (5.7%)	1 of 53 (1.9%)	Not reported
A2301	0 of 33 (0%)	1 of 33 (3%)	Not reported
A2211 IFN-free	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
A2211 Overall	0 of 12 (0%)	4 of 12 (33.3%)	Not reported

Limitations and caveats (from the sponsor): There is no statistical hypothesis for this single-arm uncontrolled terminated study. Study was powered for efficacy of 650 participants and only 105 were randomized

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. terminated

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

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

40 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Previous treatment in DEB025 study in people with Hepatitis C, Chronic, run by Novartis Pharmaceuticals at 40 sites in 16 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Germany, Romania, Taiwan, Italy and 11 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 12 Jan 2018). 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?

HCV RNA Sequencing (time frame: 27 months). 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 NCT02465203.

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 12 Jan 2018.