Hepatitis CPhase 2NCT01183169

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

A Phase 2 study testing Alisporivir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Debiopharm International SA at 75 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 participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV. 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: 459 participants
Where: 75 sitesin 14 countries
Study dates: Aug 2010to May 2013
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 HCV genotype 1 viral infection
HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

Who cannot join

Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
Women of child-bearing potential unless using highly effective
Any other cause of relevant liver disease other than HCV
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

75 sites in 14 countries.

Country

City, postcode or hospital

75 sites in 14 countries

United States18 sites

Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Brooklyn, New York, 11230
Novartis Investigative Site
Dallas, Texas, 75246-2096
Novartis Investigative Site
Egg Harbor Twp, New Jersey, 08234
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Honolulu, Hawaii, 96817
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
Orlando, Florida, 32804
Novartis Investigative Site
San Antonio, Texas, 78215
Novartis Investigative Site
San Diego, California, 92101
Novartis Investigative Site
San Diego, California, 92115
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
Springfield, Massachusetts, 01107
Novartis Investigative Site
Tampa, Florida, 33607
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Ventura, California, 93003

Other trials in United States

Taiwan7 sites

Novartis Investigative Site
Douliu, 640
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Keelung, 20401
Novartis Investigative Site
Lin-Ko, 33305
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, ROC, 112

Other trials in Taiwan

Germany6 sites

Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Leipzig, 04103

Other trials in Germany

Hungary6 sites

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

Other trials in Hungary

Italy6 sites

Novartis Investigative Site
Antella - Bagno A Ripoli, FI, 50012
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Roma, RM, 00161

Other trials in Italy

Spain6 sites

Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, Madrid, 28029
Novartis Investigative Site
Majadahonda, Madrid, 28222
Novartis Investigative Site
Seville, Andalusia, 41014

Other trials in Spain

Australia5 sites

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

Other trials in Australia

Romania5 sites

Novartis Investigative Site
Bucharest, District 1, 050526
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, Romania, 021105
Novartis Investigative Site
Bucharest, 020125
Novartis Investigative Site
Iași, Iaşi, 700506

Other trials in Romania

Turkey (Türkiye)4 sites

Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06800
Novartis Investigative Site
Fatih / Istanbul, 34098
Novartis Investigative Site
Izmir, Turkey, 35040

Other trials in Turkey (Türkiye)

United Kingdom4 sites

Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, NW3 2PR
Novartis Investigative Site
London, W2 1NY
Novartis Investigative Site
Nottingham, NG7 2UH

Other trials in United Kingdom

Poland3 sites

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

Other trials in Poland

Belgium2 sites

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

Other trials in Belgium

France2 sites

Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75006

Other trials in France

Puerto Rico1 site

Novartis Investigative Site
San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

Conditions: Hepatitis C
Being tested: Alisporivir, Peginterferon alfa-2a, Ribavirin, 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
PlaceboDrug
Also called ALV Placebo
ALV placebo soft gel capsules administered orally

Study groups in NCT01183169
Study group	Role	What they receive
Treatment A: ALV 600 mg QD	Experimental	Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Treatment B: ALV 800 mg QD	Experimental	Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Treatment C1: ALV Placebo - 600 mg QD	Experimental	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV. Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: Placebo
Treatment C2: ALV Placebo - 400 mg BID	Experimental	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV. Receives: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: Placebo
Treatment D: ALV 400 mg BID	Experimental	Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks Receives: Drug: Alisporivir; 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 Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Measured: after 12 weeks of treatment

Secondary outcomes (9)

Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Measured: after 12 weeks of treatment
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.
Measured: 12 weeks after treatment
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.
Measured: 24 weeks after treatment
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Measured: after 4 weeks of treatment
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Measured: after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.
Measured: within 48 weeks
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Measured: Up to 48 weeks
Percentage of Participants With On-treatment Viral Breakthrough
On-treatment 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 (< LOQ) during treatment
Measured: within 48 weeks
Percentage of Participants With Viral Relapse
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.
Measured: within 24 weeks after treatment

Timeline

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

Aug 2010May 2013

First posted17 Aug 2010 (estimated)
Study startAug 2010
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01183169
Sponsor's protocol ID: CDEB025A2210
Other IDs: 2010-020033-14
Status last verified: Jul 2016
First submitted: 16 Aug 2010
Last updated: 25 Aug 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 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
ClinicalTrials.gov ID: NCT01183169
Acronym / sponsor ID: CDEB025A2210
Conditions: Hepatitis C
Keywords: Chronic hepatitis C, Cyclophilin inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 17 Aug 2010 (estimated)
Results: Posted 25 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: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Treatment A: ALV 600 mg QD	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAlisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Treatment B: ALV 800 mg QD	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAlisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Treatment C1: ALV Placebo - 600 mg QD	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: Ribavirin, Drug: PlaceboALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Treatment C2: ALV Placebo - 400 mg BID	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: Ribavirin, Drug: PlaceboALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Treatment D: ALV 400 mg BID	Experimental	Drug: Alisporivir, Drug: Peginterferon alfa-2a, Drug: RibavirinAlisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks

Who may qualify

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

Key inclusion criteria (3 listed)

Chronic HCV genotype 1 viral infection
HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

Key exclusion criteria (4 listed)

Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
Women of child-bearing potential unless using highly effective
Any other cause of relevant liver disease other than HCV
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	Treatment A: ALV 600 mg QD, Treatment B: ALV 800 mg QD, Treatment C1: ALV Placebo - 600 mg QD, Treatment C2: ALV Placebo - 400 mg BID, Treatment D: ALV 400 mg BID
Peginterferon alfa-2aAlso: Pegasys®, PEGPEG 180 μg administered via subcutaneous (s.c.) injection once weekly	Drug	Treatment A: ALV 600 mg QD, Treatment B: ALV 800 mg QD, Treatment C1: ALV Placebo - 600 mg QD, Treatment C2: ALV Placebo - 400 mg BID, Treatment D: ALV 400 mg BID
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 A: ALV 600 mg QD, Treatment B: ALV 800 mg QD, Treatment C1: ALV Placebo - 600 mg QD, Treatment C2: ALV Placebo - 400 mg BID, Treatment D: ALV 400 mg BID
PlaceboAlso: ALV PlaceboALV placebo soft gel capsules administered orally	Drug	Treatment C1: ALV Placebo - 600 mg QD, Treatment C2: ALV Placebo - 400 mg BID

Primary outcome

Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
Time frame: after 12 weeks of treatment
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

9 secondary outcomes

Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
Time frame: after 12 weeks of treatment
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
Time frame: 12 weeks after treatment
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
Time frame: 24 weeks after treatment
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
Time frame: after 4 weeks of treatment
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
Time frame: after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
Time frame: within 48 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 48 weeks
Percentage of Participants With On-treatment Viral Breakthrough
Time frame: within 48 weeks
Percentage of Participants With Viral Relapse
Time frame: within 24 weeks after treatment

Results and safety

Results posted to the registry on 25 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
Treatment A	121	94
Treatment B	115	93
Treatment C1	59	18
Treatment C2	55	18
Treatment D	109	83
Treatment C1A	0	0
Treatment C2A	0	0

Primary outcome: Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)

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

Measure	Treatment A n = 110	Treatment B n = 108	Treatment C n = 110	Treatment D n = 109	Treatment C1A n = 33	Treatment C2A n = 30
Value	48.2	61.1	35.5	74.3	45.5	80.0

Population analysed: Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment

9 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 A: On-treatment AEs	7 of 120 (5.8%)	116 of 120 (96.7%)	Not reported
Treatment B: On-treatment AEs	11 of 115 (9.6%)	108 of 115 (93.9%)	Not reported
Treatment C1: On-treatment AEs	5 of 59 (8.5%)	58 of 59 (98.3%)	Not reported
Treatment C2: On-treatment AEs	1 of 55 (1.8%)	54 of 55 (98.2%)	Not reported
Treatment D: On-treatment AEs	18 of 108 (16.7%)	106 of 108 (98.1%)	Not reported
Treatment A: Post-treatment AEs	2 of 120 (1.7%)	22 of 120 (18.3%)	Not reported
Treatment B: Post-treatment AEs	4 of 115 (3.5%)	21 of 115 (18.3%)	Not reported
Treatment C1: Post-treatment AEs	0 of 59 (0%)	13 of 59 (22%)	Not reported
Treatment C2: Post-treatment AEs	0 of 55 (0%)	10 of 55 (18.2%)	Not reported
Treatment D: Post-treatment AEs	0 of 108 (0%)	19 of 108 (17.6%)	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 25 Aug 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

75 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, run by Debiopharm International SA at 75 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 3 inclusion and 4 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 25 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 75 sites in United States, Taiwan, Germany, Hungary, Italy 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 25 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 Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) (time frame: after 12 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 NCT01183169.

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 25 Aug 2016.