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.
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.
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
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
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
France3 sites
Novartis Investigative Site
Clichy, 92110
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Paris, 75006
Canada2 sites
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1J4
Novartis Investigative Site
Vancouver, British Columbia, v6z 2k5
Spain2 sites
Novartis Investigative Site
Barcelona, Barcelona, 08035
Novartis Investigative Site
Majadanonda, Madrid, 28222
United Kingdom2 sites
Novartis Investigative Site
London, NW3 3QG
Novartis Investigative Site
London, SE5 9RS
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
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).
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
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
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.
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).
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
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.
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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?
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; AzTrials last refreshed its copy on 8 Nov 2026.