Hepatitis CNCT01970904
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
A study testing Alisporivir, Ribavirin and Peg-IFNα2a in people with Hepatitis C and Liver Disease, run by Debiopharm International SA at 25 sites in 4 countries.
Trial summary
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients. 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, Ribavirin and Peg-IFNα2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 25 sitesin 4 countries
- Study dates
- Oct 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
- Chronic hepatitis C (G2 or G3) virus infection diagnosed
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.
- -
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
Germany12 sites
Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24146
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Würzburg, 97080
Sweden6 sites
Novartis Investigative Site
Gothenburg, 416 85
Novartis Investigative Site
Luleå, SE-971 80
Novartis Investigative Site
Lund, 221 85
Novartis Investigative Site
Malmö, SE-205 02
Novartis Investigative Site
Stockholm, 141 86
Novartis Investigative Site
Umeå, 901 85
United Kingdom4 sites
Novartis Investigative Site
Birmingham, B15 2TT
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SE5 9RS
Poland3 sites
Novartis Investigative Site
Bialystok, 15-540
Novartis Investigative Site
Lublin, 20-079
Novartis Investigative Site
Warsaw, 01-201
About this study
Official title: A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.
- Conditions
- Hepatitis C, Liver Disease
- Being tested
- Alisporivir, Ribavirin, Peg-IFNα2a
- Keywords
- Chronic hepatitis C, DEB025, Alisporivir, ribavirin therapy, genotype 2/3 treatment naive patients
- Medical subject headings
- Hepatitis C, Liver Diseases, 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
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
RibavirinDrug
Also called RBV
Ribavirin tablets of various strengths for oral administration
Peg-IFNα2aDrug
Peg-IFNα2a solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 200 mg BID | Experimental | Dual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). Receives: Drug: Alisporivir; Drug: Ribavirin; Drug: Peg-IFNα2a |
| 300 mg BID | Experimental | Dual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). Receives: Drug: Alisporivir; Drug: Ribavirin; Drug: Peg-IFNα2a |
| 400 mg BID | Experimental | Dual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). Receives: Drug: Alisporivir; Drug: Ribavirin; Drug: Peg-IFNα2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load drop from baseline through Week 12
Measured: Baseline through Week 12
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Measured: within 12 weeks
Change in platelet count from baseline through Week 12.
Measured: Baseline through Week 12
Secondary outcomes (1)
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Measured: 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 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
- NCT01970904
- Sponsor's protocol ID
- CDEB025A2222
- Other IDs
- 2012-004185-17
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
- ClinicalTrials.gov ID
- NCT01970904
- Acronym / sponsor ID
- CDEB025A2222
- Conditions
- Hepatitis C, Liver Disease
- Keywords
- Chronic hepatitis C, DEB025, Alisporivir, ribavirin therapy, genotype 2/3 treatment naive patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 mg BID | Experimental | Drug: Alisporivir, Drug: Ribavirin, Drug: Peg-IFNα2aDual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). |
| 300 mg BID | Experimental | Drug: Alisporivir, Drug: Ribavirin, Drug: Peg-IFNα2aDual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). |
| 400 mg BID | Experimental | Drug: Alisporivir, Drug: Ribavirin, Drug: Peg-IFNα2aDual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment 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)
- Written informed consent must be obtained before any assessment is performed.
- No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
- Chronic hepatitis C (G2 or G3) virus infection diagnosed
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.
- -
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: DEB025Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration | Drug | 200 mg BID, 300 mg BID, 400 mg BID |
| RibavirinAlso: RBVRibavirin tablets of various strengths for oral administration | Drug | 200 mg BID, 300 mg BID, 400 mg BID |
| Peg-IFNα2aPeg-IFNα2a solution for subcutaneous injection | Drug | 200 mg BID, 300 mg BID, 400 mg BID |
Primary outcome
Viral load drop from baseline through Week 12
Time frame: Baseline through Week 12
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Time frame: within 12 weeks
Change in platelet count from baseline through Week 12.
Time frame: Baseline through Week 12
1 secondary outcome
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Time frame: 12 weeks after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alisporivir, Ribavirin and Peg-IFNα2a in people with Hepatitis C and Liver Disease, run by Debiopharm International SA at 25 sites in 4 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 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Sweden, United Kingdom, Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Viral load drop from baseline through Week 12 (time frame: Baseline through Week 12). The study lists 3 primary outcomes in all. 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 20 Apr 2016.