Hepatitis CPhase 2NCT02094443

Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

A Phase 2 study testing Alisporivir and Ribavirin in people with Hepatitis C and Liver Disease, run by Debiopharm International SA at 16 sites in 2 countries.

Completed

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

Official record

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Trial summary

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Liver Disease
What is being tested?: Alisporivir and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 16 sitesin 2 countries
Study dates: Mar 2014to Apr 2015
Phase: Phase 2
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

Written informed consent must be obtained before any assessment is performed
Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
Males or females aged ≥18 years
Diagnosed Chronic hepatitis C virus infection

Who cannot join

Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Hepatitis B surface antigen (HBsAg) positive
Human immunodeficiency virus (HIV) positive
Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States11 sites

Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Bakersfield, California, 93301
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Lancaster, California, 93534
Novartis Investigative Site
Newport News, Virginia, 23602
Novartis Investigative Site
San Antonio, Texas, 78215
Novartis Investigative Site
San Diego, California, 92114
Novartis Investigative Site
San Diego, California, 92128
Novartis Investigative Site
Seattle, Washington, 98101
Novartis Investigative Site
Seattle, Washington, 98104
Novartis Investigative Site
St Louis, Missouri, 63110

Other trials in United States

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

Other trials in France

About this study

Official title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

Conditions: Hepatitis C, Liver Disease
Being tested: Alisporivir, Ribavirin
Keywords: Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor, Interferon intolerant
Medical subject headings: Hepatitis C, Liver Diseases

What participants receive

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

AlisporivirDrug
Also called DEB025
ALV 100 and 200 mg soft gel capsules administered orally
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 NCT02094443
Study group	Role	What they receive
Alisporivir 300 mg BID	Experimental	Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication Receives: Drug: Alisporivir; Drug: Ribavirin
Alisporivir 400 mg BID	Experimental	ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication Receives: Drug: Alisporivir; Drug: Ribavirin

What is being measured

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

Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Measured: Baseline, Week 12
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.
Measured: Baseline, Week 12

Secondary outcomes (5)

Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.
Measured: Up to 24 weeks posttreatment
Percentage of Participants With Extended Rapid Virologic Response
Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment
Measured: 2 weeks
Percentage of Participants With Rapid Virologic Response (RVR)
eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment
Measured: 4 weeks
Percentage of Participants With End of Treatment Response (ETR)
ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).
Measured: Up to 24 weeks
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.
Measured: Up to 24 weeks

Timeline

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

Mar 2014Apr 2015

First posted21 Mar 2014 (estimated)
Study startMar 2014
Primary completionApr 2015
Study completionApr 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02094443
Sponsor's protocol ID: CDEB025A2233
Other IDs: 2013-003751-38
Status last verified: Aug 2016
First submitted: 18 Mar 2014
Last updated: 13 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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
HCV Infection
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.
ClinicalTrials.gov ID: NCT02094443
Acronym / sponsor ID: CDEB025A2233
Conditions: Hepatitis C, Liver Disease
Keywords: Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor, Interferon intolerant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 21 Mar 2014 (estimated)
Results: Posted 13 Oct 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alisporivir 300 mg BID	Experimental	Drug: Alisporivir, Drug: RibavirinAlisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Alisporivir 400 mg BID	Experimental	Drug: Alisporivir, Drug: RibavirinALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication

Who may qualify

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

Key inclusion criteria (4 listed)

Written informed consent must be obtained before any assessment is performed
Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
Males or females aged ≥18 years
Diagnosed Chronic hepatitis C virus infection

Key exclusion criteria (5 listed)

Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Hepatitis B surface antigen (HBsAg) positive
Human immunodeficiency virus (HIV) positive
Other protocol-defined inclusion/exclusion criteria 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 100 and 200 mg soft gel capsules administered orally	Drug	Alisporivir 300 mg BID, Alisporivir 400 mg BID
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 300 mg BID, Alisporivir 400 mg BID

Primary outcome

Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
Time frame: Baseline, Week 12
The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
Time frame: Baseline, Week 12
ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.

5 secondary outcomes

Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
Time frame: Up to 24 weeks posttreatment
Percentage of Participants With Extended Rapid Virologic Response
Time frame: 2 weeks
Percentage of Participants With Rapid Virologic Response (RVR)
Time frame: 4 weeks
Percentage of Participants With End of Treatment Response (ETR)
Time frame: Up to 24 weeks
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Time frame: Up to 24 weeks

Results and safety

Results posted to the registry on 13 Oct 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 300 mg BID	26	11
Alisporivir 400 mg BID	26	9

Primary outcome: Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: log10 IU/mL

Measure	Alisporivir 300 mg BID n = 26	Alisporivir 400 mg BID n = 26
Baseline	6.323 (0.4785)	6.343 (0.6396)
Change from baseline	-3.935 (2.3361)	-3.855 (2.7506)

Population analysed: Full Analysis Set

Primary outcome: Change From Baseline in Alanine Aminotransferase (ALT) at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: U/L

Measure	Alisporivir 300 mg BID n = 21	Alisporivir 400 mg BID n = 19
Baseline	77.3 (48.57)	67.9 (42.94)
Change from baseline	-67.4 (45.99)	-58.2 (44.50)

Population analysed: Participants in the safety set with available data at the given time point

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alisporivir 300 mg BID	3 of 26 (11.5%)	22 of 26 (84.6%)	Not reported
Alisporivir 400 mg BID	3 of 26 (11.5%)	24 of 26 (92.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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
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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
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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

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alisporivir and Ribavirin in people with Hepatitis C and Liver Disease, run by Debiopharm International SA at 16 sites in 2 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 4 inclusion and 5 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Oct 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?

Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12 (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. 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 NCT02094443.

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 13 Oct 2016.