Hepatitis CPhase 3NCT01500772

Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

A Phase 3 study testing Alisporivir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Debiopharm International SA at 60 sites in 8 countries.

Terminated

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

Official record

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Trial summary

This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C
What is being tested?: Alisporivir, Peginterferon alfa-2a and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 60 sitesin 8 countries
Study dates: Mar 2012to May 2012
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with chronic HCV genotype 1 infection with previous PI treatment failure
Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Who cannot join

Use of other investigational drugs at the time of enrollment
History of hypersensitivity to PEG or RBV
Any null non-responders to prior PEG/RBV treatment
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

60 sites in 8 countries.

Country

City, postcode or hospital

60 sites in 8 countries

United States26 sites

Novartis Investigative Site
Alexandria, Virginia, 22306
Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Bakersfield, California, 93301
Novartis Investigative Site
Baltimore, Maryland, 21229
Novartis Investigational site
Bradenton, Florida, 34209
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Brockton, Massachusetts, 02302
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Cincinnati, Ohio, 45267
Novartis Investigative Site
Dallas, Texas, 75246
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
Minneapolis, Minnesota, 55404
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
New York, New York, 10029
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
Newport News, Virginia, 23602
Novartis Investigative Site
Palo Alto, California, 95128
Novartis Investigative Site
Phoenix, Arizona, 85054
Novartis Investigative Site
Providence, Rhode Island, 02905
Novartis Investigative Site
Sacramento, California, 95817
Novartis Investigative Site
San Diego, California, 92114
Novartis Investigative Site
San Diego, California, 92128
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
Ventura, California, 93003
Novartis Investigative Site
Wellington, Florida, 33414

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Germany16 sites

Novartis Investigational Site
Berlin, 10969
Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Berlin, 13353
Novartis Investigational Site
Cologne, 50924
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Düsseldorf, 40237
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigational Site
Frieburg, 79106
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Kiel, 24146
Novartis Investigational Site
Mainz, 55131
Novartis Investigative Site
Mainz, 55131

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Italy8 sites

Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Torino, TO, 10126

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France3 sites

Novartis Investigative Site
Clichy, 92110
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Paris, 75006

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Canada2 sites

Novartis Investigative Site
Vancouver, British Columbia, V5Z 1J4
Novartis Investigative Site
Vancouver, British Columbia, v6z 2k5

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Spain2 sites

Novartis Investigative Site
Barcelona, Barcelona, 08035
Novartis Investigative Site
Majadanonda, Madrid, 28222

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United Kingdom2 sites

Novartis Investigative Site
London, NW3 3QG
Novartis Investigative Site
London, SE5 9RS

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Puerto Rico1 site

Novartis Investigative Site
San Juan, 00909

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About this study

Official title: A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1

Conditions: Hepatitis C
Being tested: Alisporivir, Peginterferon alfa-2a, Ribavirin
Keywords: Hepatitis C, PI treatment failure
Medical subject headings: Hepatitis C

What participants receive

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

AlisporivirDrug
Also called DEB025
ALV 200 mg soft gel capsules administered orally
Peginterferon alfa-2aDrug
Also called Pegasys®
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
RibavirinDrug
Also called Copegus®, RBV
RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Study groups in NCT01500772
Study group	Role	What they receive
Alisporivir	Experimental	ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

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

Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
Measured: 12 weeks posttreatment

Secondary outcomes (3)

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
Measured: 24 weeks posttreatment
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Level of detection (LOD) was defined as 10 IU/mL
Measured: 12 weeks posttreatment
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Measured: 48 weeks

Timeline

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

Mar 2012May 2012

First posted28 Dec 2011 (estimated)
Study startMar 2012
Primary completionMay 2012
Study completionMay 2012

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500772
Sponsor's protocol ID: CDEB025A2306
Other IDs: 2011-004653-31
Status last verified: Jun 2016
First submitted: 23 Dec 2011
Last updated: 1 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

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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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
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Active, not recruitingPhase 4
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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1
ClinicalTrials.gov ID: NCT01500772
Acronym / sponsor ID: CDEB025A2306
Conditions: Hepatitis C
Keywords: Hepatitis C, PI treatment failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 6 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 28 Dec 2011 (estimated)
Results: Posted 27 Jun 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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Alisporivir	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with chronic HCV genotype 1 infection with previous PI treatment failure
Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Key exclusion criteria (4 listed)

Use of other investigational drugs at the time of enrollment
History of hypersensitivity to PEG or RBV
Any null non-responders to prior PEG/RBV treatment
Other protocol-defined inclusion/exclusion criteria may apply.

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: DEB025ALV 200 mg soft gel capsules administered orally	Drug	Alisporivir
Peginterferon alfa-2aAlso: Pegasys®PEG 180 μg administered via subcutaneous (s.c.) injection once weekly	Drug	Alisporivir
RibavirinAlso: Copegus®, RBVRBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose	Drug	Alisporivir

Primary outcome

Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
Time frame: 12 weeks posttreatment
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.

3 secondary outcomes

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Time frame: 24 weeks posttreatment
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Time frame: 12 weeks posttreatment
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time frame: 48 weeks

Results and safety

Results posted to the registry on 27 Jun 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
Alisporivir	6	0

Primary outcome: Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)

Time frame: 12 weeks posttreatment

Population analysed: The study was terminated before the outcome measure time point.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of treatment (maximum exposure: 25 days) plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alisporivir	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Limitations and caveats (from the sponsor): Due to early termination of the study, none of the planned outcome measures could be evaluated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 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
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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
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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

60 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alisporivir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Debiopharm International SA at 60 sites in 8 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 4 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 1 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 60 sites in United States, Germany, Italy, France, Canada and 3 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 27 Jun 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 Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) (time frame: 12 weeks posttreatment). 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 NCT01500772.

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 1 Aug 2016.