Hepatitis C, Genotype 1Phase 3NCT01471574

Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus

A Phase 3 study testing Daclatasvir, Ribavirin and PEG-Interferon alfa 2a in people with Hepatitis C, Genotype 1, run by Bristol-Myers Squibb at 86 sites in 13 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 purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Genotype 1
What is being tested?: Daclatasvir, Ribavirin and PEG-Interferon alfa 2a
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 549 participants
Where: 86 sitesin 13 countries
Study dates: Dec 2011to Sep 2014
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

Males and females, 18 to 70 years of age
Hepatitis C virus (HCV) genotype 1a or 1b
HCV-treatment naive
HCV RNA >10,000 IU/mL at screening
HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy [HAART], up to 50 patients not receiving HAART)
For patients receiving HAART, HIV RNA must be below <40 copies/mL at screening and must be <400 copies/ml for at least 6 months prior to screening

Who cannot join

Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/ mL
Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
Laboratory values:
Neutrophil count <1500 cells/μL (<1200 cells/ μL for Blacks)
Platelet count <90,000 cells/μL

Show all 9Show fewer

Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
Total bilirubin ≥34 μmol/L (or ≥2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir
Alanine aminotransferase ≥5*upper limit of normal

Trial locations and contacts

86 sites in 13 countries.

Country

City, postcode or hospital

86 sites in 13 countries

United States23 sites

University Of Alabama At Birmingham
Birmingham, Alabama, 35294
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599
Morehead Medical Plaza
Charlotte, North Carolina, 28204
Amelia Court Hiv Research Clinic
Dallas, Texas, 75235
Baylor College Of Medicine
Houston, Texas, 77030
Scripps Clinic
La Jolla, California, 92037
Southern California Permanente Medical Group
Los Angeles, California, 90027
Johns Hopkins University
Lutherville, Maryland, 21093
University Of Miami School Of Medicine
Miami, Florida, 33136
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, 12701
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
Weill Cornell Medical College
New York, New York, 10065
Saint Michael'S Medical Center
Newark, New Jersey, 07102
Orlando Immunology Center
Orlando, Florida, 32803
Desert Medical Group Inc.
Palm Springs, California, 92262
Virginia Commonwealth University
Richmond, Virginia, 23298
Texas Liver Institute
San Antonio, Texas, 78215
Ucsd Antiviral Research Center
San Diego, California, 92103
San Francisco Gen Hosp
San Francisco, California, 94110
Kaiser Permanente Medical Center
San Francisco, California, 94118
James J Peters Vamc
The Bronx, New York, 10468
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Va Connecticut Healthcare System
West Haven, Connecticut, 06516

Other trials in United States

Canada9 sites

Local Institution
Edmonton, Alberta, T6G 2B7
Local Institution
Montreal, Quebec, H2L 4P9
Local Institution
Montreal, Quebec, H2L 5B1
Local Institution
Montreal, Quebec, H3A 1T1
Local Institution
Ottawa, Ontario, K1H 8L6
Local Institution
Torono, Ontario, M5G 2N2
Local Institution
Vancouver, British Columbia, V6Z 2C7
Local Institution
Vancouver, British Columbia, V6Z 2K5
Local Institution
Victoria, British Columbia, V8V 3P9

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Russia9 sites

Local Institution
Kaluga, 248023
Local Institution
Lipetsk, 398043
Local Institution
Moscow, 111123
Local Institution
Nizhny Novgorod, 603005
Local Institution
Saint Petersburg, 190103
Local Institution
Saint Petersburg, 191167
Local Institution
Saint Petersburg, 196645
Local Institution
Saratov, 410009
Local Institution
Volgograd, 400040

Other trials in Russia

France8 sites

Local Institution
Marseille, 13274
Local Institution
Montpellier, 34295
Local Institution
Paris, 75013
Local Institution
Paris, 75014
Local Institution
Paris, 75018
Local Institution
Paris, 75475
Local Institution
Paris, 75571
Local Institution
Pessac, 33604

Other trials in France

Spain8 sites

Local Institution
Badalona, Barcelona, 08916
Local Institution
Barcelona, 08003
Local Institution
Córdoba, 14004
Local Institution
Madrid, 28007
Local Institution
Madrid, 28040
Local Institution
Madrid, 28041
Local Institution
Madrid, 28046
Local Institution
Seville, 41014

Other trials in Spain

Argentina5 sites

Local Institution
Buenos Aires, Buenos Aires, 1181
Local Institution
Buenos Aires, Buenos Aires, C1181
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1121ABE
Local Institution
Córdoba, Córdoba Province, 5000
Local Institution
Prov de Santa Fe, Santa Fe Province, 2000

Other trials in Argentina

Germany5 sites

Local Institution
Berlin, 13353
Local Institution
Bonn, 53105
Local Institution
Frankfurt, 60590
Local Institution
Frankfurt am Main, 60311
Local Institution
Hamburg, 20146

Other trials in Germany

Italy5 sites

Local Institution
Brescia, 25123
Local Institution
Milan, 20127
Local Institution
Milan, 20162
Local Institution
Modena, 41100
Local Institution
Torino, 10149

Other trials in Italy

Australia4 sites

Local Institution
Clayton, Victoria, 3168
Local Institution
Darlinghurst, New South Wales, 2010
Local Institution
Darlinghurst Nsw, New South Wales, 2010
Local Institution
Parkville, Victoria, 3050

Other trials in Australia

Brazil4 sites

Local Institution
Porto Alegre, Rio Grande do Sul, 90035
Local Institution
Rio de Janeiro, Rio de Janeiro, 20270
Local Institution
Rio de Janeiro, Rio de Janeiro, 21040
Local Institution
São Paulo, São Paulo, 04035

Other trials in Brazil

Belgium3 sites

Local Institution
Antwerp, 2000
Local Institution
Brussels, 1070
Local Institution
Brussels, B-1000

Other trials in Belgium

Puerto Rico2 sites

Fundacion De Investigacion De Diego
San Juan, 00927
University Of Puerto Rico School Of Medicine
San Juan, 00935

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United Kingdom1 site

Local Institution
London, Greater London, SW10 9NH

Other trials in United Kingdom

About this study

Official title: A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

Conditions: Hepatitis C, Genotype 1
Being tested: Daclatasvir, Ribavirin, PEG-Interferon alfa 2a
Medical subject headings: Hepatitis C

What participants receive

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

DaclatasvirDrug
Also called BMS-790052
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
RibavirinDrug
Also called Copegus®
Tablets; oral; for patients weighing <75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing >75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response
PEG-Interferon alfa 2aDrug
Also called Pegasys®, Pegylated interferon
Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response

Study groups in NCT01471574
Study group	Role	What they receive
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a	Experimental	Not described Receives: Drug: Daclatasvir; Drug: Ribavirin; Drug: PEG-Interferon alfa 2a

What is being measured

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

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
Measured: Follow-up Week 12

Secondary outcomes (5)

Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)
Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
Measured: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
Measured: Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.
Measured: End of treatment (up to Week 48)
Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Percentages calculated as number of responders/number who received treatment.
Measured: Follow-up Week 12
Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.
Measured: From Day 1 to 7 days post last dose of study treatment (up to Week 48)

Timeline

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

Dec 2011Sep 2014

First posted15 Nov 2011 (estimated)
Study startDec 2011
Primary completionJun 2014
Study completionSep 2014

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 C, Genotype 1Studies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 549 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01471574
Sponsor's protocol ID: AI444-043
Other IDs: 2011-003067-30
Status last verified: Dec 2015
First submitted: 4 Nov 2011
Last updated: 29 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Cote P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.
PubMed 28210927

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)
ClinicalTrials.gov ID: NCT01471574
Acronym / sponsor ID: AI444-043
Conditions: Hepatitis C, Genotype 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 549 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jun 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 15 Nov 2011 (estimated)
Results: Posted 17 Dec 2015

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a	Experimental	Drug: Daclatasvir, Drug: Ribavirin, Drug: PEG-Interferon alfa 2a

Who may qualify

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

Key inclusion criteria (6 listed)

Males and females, 18 to 70 years of age
Hepatitis C virus (HCV) genotype 1a or 1b
HCV-treatment naive
HCV RNA >10,000 IU/mL at screening
HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy [HAART], up to 50 patients not receiving HAART)

Key exclusion criteria (9 listed)

Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/ mL
Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
Laboratory values:

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
DaclatasvirAlso: BMS-790052Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks	Drug	Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
RibavirinAlso: Copegus®Tablets; oral; for patients weighing <75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing >75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response	Drug	Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
PEG-Interferon alfa 2aAlso: Pegasys®, Pegylated interferonSyringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response	Drug	Daclatsvir + Ribavirin + PEG-Interferon alfa-2a

Primary outcome

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Time frame: Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.

5 secondary outcomes

Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)
Time frame: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Time frame: Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
Time frame: End of treatment (up to Week 48)
Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Time frame: Follow-up Week 12
Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
Time frame: From Day 1 to 7 days post last dose of study treatment (up to Week 48)

Results and safety

Results posted to the registry on 17 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg	132	101
HAART: Daclatasvir, 60 mg	39	29
HAART: Daclatasvir, 30 mg + 60 mg	106	82
Non--HAART Therapy	24	21

Primary outcome: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time frame: Follow-up Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg n = 132	HAART Therapy: Daclatasvir, 60 mg n = 39	HAART: Daclatasvir, 30 mg + 60 mg n = 106	HAART Therapy: Daclatasvir 30 or 60 or 90 mg n = 277	Non-HAART Therapy: Daclatasvir, 60 mg n = 24
Value	75 (67.6 to 82.4)	71.8 (57.7 to 85.9)	71.7 (63.1 to 80.3)	73.3 (68.1 to 78.5)	87.5 (74.3 to 100)

Population analysed: The analysis was performed in all participants who received at least 1 dose of study therapy.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 to 7 days post last dose of study treatment (up to Week 48). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg	12 of 132 (9.1%)	122 of 132 (92.4%)	Not reported
HAART Therapy: Daclatasvir, 60 mg	6 of 39 (15.4%)	38 of 39 (97.4%)	Not reported
HAART: Daclatasvir, 30 mg + 60 mg	6 of 106 (5.7%)	100 of 106 (94.3%)	Not reported
Non-HAART Therapy: Daclatasvir, 60 mg	0 of 24 (0%)	23 of 24 (95.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28210927Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Cote P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.

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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

86 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daclatasvir, Ribavirin and PEG-Interferon alfa 2a in people with Hepatitis C, Genotype 1, run by Bristol-Myers Squibb at 86 sites in 13 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 6 inclusion and 9 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, Russia, France, Spain and 8 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 17 Dec 2015). 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 Sustained Virologic Response at Follow-up Week 12 (SVR12) (time frame: Follow-up Week 12). 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 NCT01471574, 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 29 Jan 2016.