Hepatitis CPhase 3NCT01318694

Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

A Phase 3 study testing Alisporivir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Debiopharm International SA at 146 sites in 21 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

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1) 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?: Yes, some participants may receive a placebo
How many people: 1,081 participants
Where: 146 sitesin 21 countries
Study dates: Mar 2011to Aug 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 infection
HCV genotype 1
No previous treatment for hepatitis C infection
Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

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 upper limit of normal (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

146 sites in 21 countries.

Country

City, postcode or hospital

146 sites in 21 countries

United States32 sites

Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Baltimore, Maryland, 21202
Novartis Investigative Site
Baltimore, Maryland, 21229
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Brooklyn, New York, 11230
Novartis Investigative Site
Charlotte, North Carolina, 28203
Novartis Investigative Site
Dallas, Texas, 75246-2096
Novartis Investigative Site
Dallas, Texas, 75390
Novartis Investigative Site
Fairfax, Virginia, 22031
Novartis Investigative Site
Fayetteville, North Carolina, 28304
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Indianapolis, Indiana, 46237
Novartis Investigative Site
Maitland, Florida, 32751
Novartis Investigative Site
Minneapolis, Minnesota, 55404
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
Newark, New Jersey, 07102
Novartis Investigative Site
Newport News, Virginia, 23602
Novartis Investigative Site
Oakland, California, 94612
Novartis Investigative Site
Omaha, Nebraska, 68198
Novartis Investigative Site
Salt Lake City, Utah, 84124
Novartis Investigative Site
San Antonio, Texas, 78215
Novartis Investigative Site
San Diego, California, 92101
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
San Diego, California, 92128
Novartis Investigative Site
Shreveport, Louisiana, 71130-3932
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
St Louis, Missouri, 63128
Novartis Investigative Site
Tampa, Florida, 33607
Novartis Investigative Site
Ventura, California, 93003

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Italy13 sites

Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20121
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Naples, 80135
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Torino, TO, 10126

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Germany11 sites

Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24146
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mainz, 55131

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Canada8 sites

Novartis Investigative Site
Calgary, Alberta, T2N 4n1
Novartis Investigative Site
Downsview, Ontario, M3N 2Z9
Novartis Investigative Site
London, Ontario, N6A 4G5
Novartis Investigative Site
Toronto, Ontario, M5G 2C4
Novartis Investigative Site
Toronto, Ontario, M5T 2S8
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1J4
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1M9
Novartis Investigative Site
Vancouver, British Columbia, v6z 2k5

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Hungary8 sites

Novartis Investigative Site
Békéscsaba, H-5600
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1097
Novartis Investigative Site
Budapest, 1126
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Pécs, 7624
Novartis Investigative Site
Székesfehérvár, 8000

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South Korea8 sites

Novartis Investigative Site
Busan, Busan, 602-739
Novartis Investigative Site
Busan, 602-715
Novartis Investigative Site
Incheon, 22332
Novartis Investigative Site
Kyunggi, Kyeonggi, 463-712
Novartis Investigative Site
Pusan, 614-735
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, 626-770

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Romania7 sites

Novartis Investigative Site
Bucharest, District 1, 050524
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, 020125
Novartis Investigative Site
Cluj-Napoca, 400006
Novartis Investigative Site
Craiova, 200515
Novartis Investigative Site
Iași, Iaşi, 700506
Novartis Investigative Site
Iași, Jud. Iasi, 700111

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Australia6 sites

Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Novartis Investigative Site
Fitzroy, Victoria, 3065
Novartis Investigative Site
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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Russia6 sites

Novartis Investigative Site
Moscow, 111123
Novartis Investigative Site
Moscow, 119333
Novartis Investigative Site
Moscow, 119992
Novartis Investigative Site
Moscow, 127473
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Saint Petersburg, 197376

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Spain6 sites

Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, Madrid, 28029
Novartis Investigative Site
Majadahonda, Madrid, 28222
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Valencia, Valencia, 46014

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Taiwan6 sites

Novartis Investigative Site
Chiayi City, Taiwan, 600
Novartis Investigative Site
Douliu, 640
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan, 10002

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United Kingdom6 sites

Novartis Investigative Site
Birmingham, B15 2TT
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
London, W2 1NY
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
Novartis Investigative Site
Nottingham, NG7 2UH

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Argentina5 sites

Novartis Investigative Site
Buenos Aires, Buenos Aires, C1125ABE
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1405BCK
Novartis Investigative Site
Córdoba, Córdoba Province, X5004BAL
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DSV
Novartis Investigative Site
Rosario, Santa Fe Province, S2002KDS

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France5 sites

Novartis Investigative Site
Clichy, 92110
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Villejuif, 94805

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Poland5 sites

Novartis Investigative Site
Bialystok, 15-540
Novartis Investigative Site
Bydgoszcz, 85-030
Novartis Investigative Site
Chorzów, 41-500
Novartis Investigative Site
Kielce, 25-317
Novartis Investigative Site
Lódz, 91-347

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Thailand5 sites

Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Khon Kaen, 40002
Novartis Investigative Site
Songkhla, 90110

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Belgium3 sites

Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Brussels, 1090
Novartis Investigative Site
Ghent, 9000

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Mexico2 sites

Novartis Investigative Site
Mexico City, Mexico City, 14000
Novartis Investigative Site
Monterrey, Nuevo León, 64020

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Vietnam2 sites

Novartis Investigative Site
Hanoi
Novartis Investigative Site
Ho Chi Minh City

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Hong Kong1 site

Novartis Investigative Site
Hong Kong, Hong Kong

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Puerto Rico1 site

Novartis Investigative Site
San Juan, 00909

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About this study

Official title: A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

Conditions: Hepatitis C
Being tested: Alisporivir, Peginterferon alfa-2a, Ribavirin, ALV Placebo
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
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 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
ALV PlaceboDrug
Also called Placebo
ALV placebo soft gel capsules administered orally

Study groups in NCT01318694
Study group	Role	What they receive
Treatment Arm A	Experimental	Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Treatment Arm B	Experimental	Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT) Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Treatment Arm C	Experimental	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Treatment Arm D	Active comparator	ALV Placebo with PEG and RBV for 48 weeks Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: ALV Placebo

What is being measured

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

Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.
Measured: 12 weeks after the end of treatment

Secondary outcomes (11)

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 after the end of treatment
Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.
Measured: after 4 weeks of treatment
Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.
Measured: after 12 weeks of treatment
Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.
Measured: after 12 weeks of treatment
Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.
Measured: after 12 weeks of treatment
Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.
Measured: from 4 to 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).
Measured: at treatment end within 48 weeks
Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
ALT abnormalities were summarized as participants who had either:
- ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
- ALT > 3 x ULN during the study and > 2 x ULN at baseline
Measured: within 48 weeks
Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
Grading was according to the Modified Division of Microbiology \& Infectious Diseases (DMID) Toxicity Tables (version 2.0).
Participants with multiple abnormalities were counted only once in the worst category.
Measured: within 48 weeks
Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Measured: within 48 weeks
Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Measured: within 48 weeks

Timeline

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

Mar 2011Aug 2013

First posted18 Mar 2011 (estimated)
Study startMar 2011
Primary completionAug 2013
Study completionAug 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,081 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318694
Sponsor's protocol ID: CDEB025A2301
Other IDs: 2010-022867-37
Status last verified: Aug 2016
First submitted: 17 Mar 2011
Last updated: 30 Sep 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?

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Study at a glance

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

Official title: A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients
ClinicalTrials.gov ID: NCT01318694
Acronym / sponsor ID: CDEB025A2301
Conditions: Hepatitis C
Keywords: Chronic hepatitis C, Cyclophilin inhibitor
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,081 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 30 Sep 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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Treatment Arm A	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAlisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
Treatment Arm B	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAlisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
Treatment Arm C	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAlisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
Treatment Arm D	Active comparator	Drug: Peginterferon alfa-2a, Drug: Ribavirin, Drug: ALV PlaceboALV Placebo with 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 (5 listed)

Chronic HCV infection
HCV genotype 1
No previous treatment for hepatitis C infection
Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

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 upper limit of normal (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: DEB025, ALVALV 200 mg soft gel capsules administered orally	Drug	Treatment Arm A, Treatment Arm B, Treatment Arm C
Peginterferon alfa-2aAlso: Pegasys®, PEGPEG 180 μg administered via subcutaneous (s.c.) injection once weekly	Drug	Treatment Arm A, Treatment Arm B, Treatment Arm C, Treatment Arm D
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	Treatment Arm A, Treatment Arm B, Treatment Arm C, Treatment Arm D
ALV PlaceboAlso: PlaceboALV placebo soft gel capsules administered orally	Drug	Treatment Arm D

Primary outcome

Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
Time frame: 12 weeks after the end of treatment
SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.

11 secondary outcomes

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Time frame: 24 weeks after the end of treatment
Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
Time frame: after 4 weeks of treatment
Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
Time frame: after 12 weeks of treatment
Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
Time frame: after 12 weeks of treatment
Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
Time frame: after 12 weeks of treatment
Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
Time frame: from 4 to 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
Time frame: at treatment end within 48 weeks
Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
Time frame: within 48 weeks
Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
Time frame: within 48 weeks
Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
Time frame: within 48 weeks
Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
Time frame: within 48 weeks

Results and safety

Results posted to the registry on 30 Sep 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
Treatment Arm A	275	223
Treatment Arm B	270	212
Treatment Arm C	268	225
Treatment Arm D	268	200

Primary outcome: Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)

Time frame: 12 weeks after the end of treatment. Number. Unit: percentage of participants

Measure	Treatment Arm A n = 274	Treatment Arm B n = 270	Treatment Arm C n = 265	Treatment Arm D n = 268
Value	68.6	68.9	69.4	52.5

Population analysed: Full Analysis Set

11 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
Treatment Arm A	24 of 273 (8.8%)	256 of 273 (93.8%)	Not reported
Treatment Arm B	28 of 268 (10.4%)	261 of 268 (97.4%)	Not reported
Treatment Arm C	21 of 265 (7.9%)	250 of 265 (94.3%)	Not reported
Treatment Arm D	28 of 265 (10.6%)	242 of 265 (91.3%)	Not reported

Limitations and caveats (from the sponsor): In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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

146 sites in 21 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 146 sites in 21 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 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: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Italy, Germany, Canada, Hungary and 16 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 30 Sep 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 Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) (time frame: 12 weeks after the end 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 NCT01318694.

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 Sep 2016.