Hepatitis CPhase 2NCT01215643

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

A Phase 2 study testing Alisporivir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C and Chronic Pain, run by Debiopharm International SA at 73 sites in 14 countries.

Completed

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

Official record

Search all trials

Trial summary

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Chronic Pain
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: 340 participants
Where: 73 sitesin 14 countries
Study dates: Oct 2010to May 2012
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic hepatitis C viral infection
Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
HCV genotype 2 or 3
No previous treatment for hepatitis C infection

Who cannot join

Evidence of cirrhosis at the time of screening
Evidence of hepatocellular carcinoma at the time of screening
Any other cause of relevant liver disease other than HCV
Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

73 sites in 14 countries.

Country

City, postcode or hospital

73 sites in 14 countries

United States16 sites

The North Texas Research Institute
Arlington, Texas, 76012
Hawai Medical Center East LLC
Honolulu, Hawaii, 96817
Liver Associates of Texas
Houston, Texas, 77030
Liver Specialist of Texas
Houston, Texas, 77030
Scripps Clinic
La Jolla, California, 92037
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Weill Cornell Medical Center
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Alamo Medical Research
San Antonio, Texas, 78215
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92101
Research and Education Inc.
San Diego, California, 92105
The Office of Dr. Claudia Martorell
Springfield, Massachusetts, 01107
Saint Louis University
St Louis, Missouri, 63104
Cotton O'Neil Clinical Research
Topeka, Kansas, 66606
Island View Gastroenterology Associates
Ventura, California, 93003

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India9 sites

Novartis Investigative Site
Guwahati, 781006
Novartis Investigative Site
Haryāna, 122001
Novartis Investigative Site
Hyderabad - Andhra Pradesh, 500012
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226014
Novartis Investigative Site
Ludhiana, Punjab, 141001
Novartis Investigative Site
Mumbai, Maharashtra, 400036
Novartis Investigative Site
Mumbai, 400020
Novartis Investigative Site
New Delhi, 110070
Novartis Investigative Site
Trivandrum, Kerala, 695607

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Australia6 sites

Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Fitzroy, Victoria, 3065
Novartis Investigative Center
Greenslopes, Queensland, 4120
Novartis Investigative Site
Kingswood, New South Wales, 2747
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Westmead, New South Wales, 2145

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Taiwan6 sites

Novartis Investigative Site
Douliu
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Niaosong Township, 83301
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, ROC112

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United Kingdom6 sites

Novartis Investigative Site
Glasgow - Scotland, G12 OYN
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
London, SW17 0QT
Novartis Investigative Site
London, W2 1NY
Novartis Investigative Site
Plymouth, PL6 8DH

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Germany5 sites

Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79095
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Leipzig, 04103

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Italy5 sites

Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Brescia, 25123
Novartis Investigative Site
Pavia, 27100
Novartis Inestigative Site
Roma, 00133
Novartis Investigative Site
Torino, 10126

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France4 sites

Novartis Investigative Site
Clichy, 92118
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Marseille, 13008
Novartis Investigative Site
Paris, 75006

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South Korea4 sites

Novartis Inestigative Center
Pusan, 602-739
Novartis Investigative Site
Pusan, 614-735
Novartis Korea Ltd.
Seoul, Seoul, 120-752
Novartis Investigative Site
Seoul, 738-736

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Belgium3 sites

Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000

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Poland3 sites

Novartis Investigative Site
Bialystok, 15-540
Novartis Investigative Site
Lódz, 91-347
Novartis Investigative Site
Warsaw, 01 - 201

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Thailand3 sites

Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Songkhla, 90110

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Canada2 sites

Novartis Investigative Site
Toronto, Ontario, M4V 1P7
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1H2

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Puerto Rico1 site

Fundacion de Investigacion de Diego
San Juan, 00927

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About this study

Official title: A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

Conditions: Hepatitis C, Chronic Pain
Being tested: Alisporivir, Peginterferon alfa-2a, Ribavirin
Keywords: Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor
Medical subject headings: Hepatitis C, Chronic Pain

What participants receive

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

AlisporivirDrug
Also called DEB025, ALV
ALV 200 mg soft gel capsules administered orally
Peginterferon alfa-2aDrug
Also called Pegasys®, PEG
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
RibavirinDrug
Also called Copegus®, RBV
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)

Study groups in NCT01215643
Study group	Role	What they receive
ALV 1000 mg	Experimental	Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24. Receives: Drug: Alisporivir
ALV 600 mg+RBV	Experimental	Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24. Receives: Drug: Alisporivir; Drug: Ribavirin
ALV 800 mg+RBV	Experimental	Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. Receives: Drug: Alisporivir; Drug: Ribavirin
ALV 600 mg+PEG	Experimental	Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24. Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a
PEG+RBV	Active comparator	Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24. Receives: 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 With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.
Measured: after 4 weeks of treatment

Secondary outcomes (17)

Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.
Measured: after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Measured: after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Measured: after 4 weeks of treatment
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
Measured: after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Measured: after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Measured: after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
Measured: at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Measured: at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Measured: at end of treatment, within 24 weeks
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
Measured: 12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Measured: 12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Measured: 12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Measured: 24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Measured: 24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Measured: 24 weeks after the end of treatment
Percentage of Participants With On-treatment Viral Breakthrough
Viral breakthrough was defined as either:
- Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
- HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment
Measured: within 24 weeks of treatment
Percentage of Participants With Viral Relapse
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
Measured: within 24 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.

Oct 2010May 2012

First posted6 Oct 2010 (estimated)
Study startOct 2010
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.
Publications (1)Papers the sponsor has linked to this study.
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: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215643
Sponsor's protocol ID: CDEB025A2211
Other IDs: 2010-020034-26
Status last verified: Jul 2016
First submitted: 5 Oct 2010
Last updated: 30 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.
PubMed 26118427

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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
ClinicalTrials.gov ID: NCT01215643
Acronym / sponsor ID: CDEB025A2211
Conditions: Hepatitis C, Chronic Pain
Keywords: Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 30 Aug 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: 5

Arm	Type	Receives
ALV 1000 mg	Experimental	Drug: AlisporivirAlisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
ALV 600 mg+RBV	Experimental	Drug: Alisporivir, Drug: RibavirinAlisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
ALV 800 mg+RBV	Experimental	Drug: Alisporivir, Drug: RibavirinAlisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg+PEG	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2aAlisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
PEG+RBV	Active comparator	Drug: Peginterferon alfa-2a, Drug: RibavirinPeginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.

Who may qualify

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

Key inclusion criteria (4 listed)

Chronic hepatitis C viral infection
Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
HCV genotype 2 or 3
No previous treatment for hepatitis C infection

Key exclusion criteria (5 listed)

Evidence of cirrhosis at the time of screening
Evidence of hepatocellular carcinoma at the time of screening
Any other cause of relevant liver disease other than HCV
Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
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: DEB025, ALVALV 200 mg soft gel capsules administered orally	Drug	ALV 1000 mg, ALV 600 mg+PEG, ALV 600 mg+RBV, ALV 800 mg+RBV
Peginterferon alfa-2aAlso: Pegasys®, PEGPEG 180 μg administered via subcutaneous (s.c.) injection once weekly	Drug	ALV 600 mg+PEG, PEG+RBV
RibavirinAlso: Copegus®, RBVRBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)	Drug	ALV 600 mg+RBV, ALV 800 mg+RBV, PEG+RBV

Primary outcome

Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
Time frame: after 4 weeks of treatment
RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.

17 secondary outcomes

Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
Time frame: after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Time frame: after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Time frame: after 4 weeks of treatment
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
Time frame: after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Time frame: after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Time frame: after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
Time frame: at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Time frame: at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Time frame: at end of treatment, within 24 weeks
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
Time frame: 12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Time frame: 12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Time frame: 12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Time frame: 24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Time frame: 24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Time frame: 24 weeks after the end of treatment
Percentage of Participants With On-treatment Viral Breakthrough
Time frame: within 24 weeks of treatment
Percentage of Participants With Viral Relapse
Time frame: within 24 weeks after the end of treatment

Results and safety

Results posted to the registry on 30 Aug 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
ALV 1000 mg	83	74
ALV 600 mg+RBV	84	80
ALV 800 mg+RBV	94	82
ALV 600 mg+PEG	39	35
PEG+RBV	40	29

Primary outcome: Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)

Time frame: after 4 weeks of treatment. Number. Unit: percentage of participants

Measure	ALV 1000 mg n = 81	ALV 600 mg+RBV n = 84	ALV 800 mg+RBV n = 93	ALV 600 mg+PEG n = 39	PEG+RBV n = 40
Value	28.4	36.9	41.9	84.6	72.5

Population analysed: Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.

17 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
ALV 1000 mg: On-treatment AEs	4 of 82 (4.9%)	64 of 82 (78%)	Not reported
ALV 600 mg+RBV: On-treatment AEs	1 of 84 (1.2%)	69 of 84 (82.1%)	Not reported
ALV 800 mg+RBV: On-treatment AEs	9 of 94 (9.6%)	76 of 94 (80.9%)	Not reported
ALV 600 mg+PEG: On-treatment AEs	4 of 39 (10.3%)	37 of 39 (94.9%)	Not reported
PEG+RBV: On-treatment AEs	2 of 37 (5.4%)	30 of 37 (81.1%)	Not reported
ALV 1000 mg: Post-treatment AEs	2 of 82 (2.4%)	10 of 82 (12.2%)	Not reported
ALV 600 mg+RBV: Post-treatment AEs	4 of 84 (4.8%)	10 of 84 (11.9%)	Not reported
ALV 800 mg+RBV: Post-treatment AEs	1 of 94 (1.1%)	13 of 94 (13.8%)	Not reported
ALV 600 mg+PEG: Post-treatment AEs	0 of 39 (0%)	5 of 39 (12.8%)	Not reported
PEG+RBV: Post-treatment AEs	0 of 37 (0%)	2 of 37 (5.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26118427Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.

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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 Pharmceuticals study director

Novartis Pharmaceuticals

73 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alisporivir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C and Chronic Pain, run by Debiopharm International SA at 73 sites in 14 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 30 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 73 sites in United States, India, Australia, Taiwan, United Kingdom and 9 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 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 30 Aug 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 With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ) (time frame: after 4 weeks of treatment). 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 NCT01215643, which also lists 1 linked publication.

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 30 Aug 2016.