Hepatitis CPhase 3NCT01446250

Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

A Phase 3 study testing Alisporivir, Boceprevir and Peginterferon alfa-2a in people with Hepatitis C, run by Debiopharm International SA at 2 sites in United States.

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 will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection. 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, Boceprevir and Peginterferon alfa-2a
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 2 sitesUnited States
Study dates: Dec 2011to May 2013
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

Chronic HCV genotype 1 infection
No previous treatment for HCV infection
African American ethnicity
Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
A liver biopsy within 3 years prior to baseline

Who cannot join

HCV genotype different from genotype 1 or co-infection with other HCV genotype
Co-infection with Hepatitis B or HIV
Any other cause of relevant liver disease other than HCV
Presence or history of hepatic decompensation
Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (> ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Novartis Investigational Site
Baltimore, Maryland, 21229
Novartis Investigational Site
Beverly Hills, California, 90211

Other trials in United States

About this study

Official title: A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

Conditions: Hepatitis C
Being tested: Alisporivir, Boceprevir, Peginterferon alfa-2a, Ribavirin
Keywords: Chronic hepatitis C, Cyclophilin inhibitor
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
ALV 200 mg soft gel capsules administered orally
BoceprevirDrug
Also called Victrelis®
BOC 800 mg (4 x 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 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 NCT01446250
Study group	Role	What they receive
Alisporivir	Experimental	At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy. Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Boceprevir	Active comparator	Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C). Receives: Drug: Boceprevir; 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 That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Measured: within 48 weeks

Secondary outcomes (2)

Percentage of Participants With Emergence of Resistant Mutations
Measured: within 48 weeks
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Measured: 24 weeks post-treatment

Timeline

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

Dec 2011May 2013

First posted5 Oct 2011 (estimated)
Study startDec 2011
Primary completionMay 2013
Study completionMay 2013

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01446250
Sponsor's protocol ID: CDEB025A2307
Status last verified: Nov 2016
First submitted: 26 Sep 2011
Last updated: 16 Jan 2017
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 at a glance

From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With Chronic Hepatitis C Genotype 1
ClinicalTrials.gov ID: NCT01446250
Acronym / sponsor ID: CDEB025A2307
Conditions: Hepatitis C
Keywords: Chronic hepatitis C, Cyclophilin inhibitor
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 8 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 5 Oct 2011 (estimated)
Results: Posted 16 Jan 2017

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alisporivir	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAt the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.
Boceprevir	Active comparator	Drug: Boceprevir, Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).

Who may qualify

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

Key inclusion criteria (5 listed)

Chronic HCV genotype 1 infection
No previous treatment for HCV infection
African American ethnicity
Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
A liver biopsy within 3 years prior to baseline

Key exclusion criteria (6 listed)

HCV genotype different from genotype 1 or co-infection with other HCV genotype
Co-infection with Hepatitis B or HIV
Any other cause of relevant liver disease other than HCV
Presence or history of hepatic decompensation
Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (> ULN) in past 6 months

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
BoceprevirAlso: Victrelis®BOC 800 mg (4 x 200 mg soft gel capsules) administered orally	Drug	Boceprevir
Peginterferon alfa-2aAlso: Pegasys®PEG 180 μg administered via subcutaneous (s.c.) injection once weekly	Drug	Alisporivir, Boceprevir
RibavirinAlso: Copegus®RBV 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, Boceprevir

Primary outcome

Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time frame: within 48 weeks

2 secondary outcomes

Percentage of Participants With Emergence of Resistant Mutations
Time frame: within 48 weeks
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
Time frame: 24 weeks post-treatment

Results and safety

Results posted to the registry on 16 Jan 2017, 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	5	5
Boceprevir	3	2
PEGinf + RBV	0	0
No Intervention	0	0

Primary outcome: Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events

Time frame: within 48 weeks

Population analysed: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.

2 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
Alisporivir	0 of 5 (0%)	5 of 5 (100%)	Not reported
Boceprevir	1 of 8 (12.5%)	8 of 8 (100%)	Not reported
PEGinf + RBV	0 of 8 (0%)	4 of 8 (50%)	Not reported
No Intervention	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Limitations and caveats (from the sponsor): Due to the early termination of study enrollment and discontinuation of alisporivir treatment, Amendment 1 changed the number of study arms to 2, combining Arms A and B, and 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 16 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Not yet recruitingObservational study
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Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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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 Pharmaceticals study director

Novartis Pharmaceuticals

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alisporivir, Boceprevir and Peginterferon alfa-2a in people with Hepatitis C, run by Debiopharm International SA at 2 sites in United States.

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 6 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 16 Jan 2017). 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 That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events (time frame: within 48 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 NCT01446250.

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 16 Jan 2017.