Hepatitis CPhase 2COSMOSNCT01466790

A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients

A Phase 2 study testing TMC435, PSI-7977 (GS7977) and Ribavirin in people with Hepatitis C, run by Janssen R&D Ireland at 23 sites in 2 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never… 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?: TMC435, PSI-7977 (GS7977) and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 23 sitesin 2 countries
Study dates: Jan 2012to Jan 2014
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 genotype 1 hepatitis C virus (HCV) infection
Plasma HCV RNA of more than 10,000 IU/mL at screening
Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks
Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks and could also be HCV treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of HCV
Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 of the most recent PegIFN/ribavirin therapy
Patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed Metavir F3 or F4 fibrosis
Must agree to use 2 forms of effective contraception throughout the study (male and female)

Who cannot join

Has evidence of hepatic decompensation
Has any liver disease of non-HCV etiology
Has an infection/co-infection with non-genotype 1 HCV
Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)
Has a co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
Has a history of malignancy within 5 years of the screening visit

Trial locations and contacts

23 sites in 2 countries.

Country

City, postcode or hospital

23 sites in 2 countries

United States22 sites

Study site
Arlington, Texas
Study site
Atlanta, Georgia
Study site
Bakersfield, California
Study site
Brandenton, Florida
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Falls Church, Virginia
Study site
Hoover, Alabama
Study site
Jacksonville, Florida
Study site
La Jolla, California
Study site
Lebanon, New Hampshire
Study site
Lutherville, Maryland
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Pittsburgh, Pennsylvania
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Seatle, Washington
Study site
Tampa, Florida
Study site
Wellington, Florida

Other trials in United States

Puerto Rico1 site

Study site
Santurce

Other trials in Puerto Rico

About this study

Official title: An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects

Read the detailed description

This is a Phase IIa, randomized (the study medications are assigned by chance), open label (all people know the identity of the intervention) study of TMC435 plus PSI-7977 (GS7977) with or without ribavirin. The study consists of a screening phase (6 weeks); a treatment phase (12 or 24 week period); and a posttreatment phase (follow-up period up to Week 48). Approximately 180 patients will be enrolled in this study. Patients will be sequentially enrolled into two cohorts in this study. Cohort 1 (90 patients) will include patients without advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy and Cohort 2 (90 patients) will include only patients with advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy or are HCV treatment-naive. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The entire study duration for each participant will be approximately 48 weeks.

Conditions: Hepatitis C
Being tested: TMC435, PSI-7977 (GS7977), Ribavirin
Keywords: Hepatitis C, TMC435, PSI-7977, GS7977, Ribavirin, HCV, Hep C, Genotype 1
Medical subject headings: Hepatitis C

What participants receive

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

TMC435Drug
TMC435 will be administered as one oral capsule of 150 mg once a day.
PSI-7977 (GS7977)Drug
Also called GS7977
PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.
RibavirinDrug
Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).

Study groups in NCT01466790
Study group	Role	What they receive
Arm 1	Experimental	30 patients will receive TMC435 (150 mg once a day) plus PSI-7977(GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 24 weeks and followed by a 24-week follow-up phase. Receives: Drug: TMC435; Drug: PSI-7977 (GS7977); Drug: Ribavirin
Arm 2	Experimental	15 patients wiil receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 24 weeks of and followed by a 24-week follow-up phase. Receives: Drug: TMC435; Drug: PSI-7977 (GS7977)
Arm 3	Experimental	30 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 12 weeks and followed by a 36-week follow-up phase. Receives: Drug: TMC435; Drug: PSI-7977 (GS7977); Drug: Ribavirin
Arm 4	Experimental	15 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 12 weeks and followed by a 36-week follow-up phase. Receives: Drug: TMC435; Drug: PSI-7977 (GS7977)

What is being measured

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

Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.
Measured: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)

Secondary outcomes (6)

Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.
Measured: Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)
Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.
Measured: Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)
Number of Participants With a Sustained Virologic Response (SVR) at Week 48
Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.
Measured: Week 48
Number of Participants With Viral Breakthrough
Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.
Measured: Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Number of Participants With Inadequate Virologic Response
Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.
Measured: Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Number of Participants With Viral Relapse
Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.
Measured: During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

Timeline

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

Jan 2012Jan 2014

First posted8 Nov 2011 (estimated)
Study startJan 2012
Primary completionNov 2013
Study completionJan 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 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: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01466790
Sponsor's protocol ID: CR018724
Other IDs: TMC435HPC2002
Acronym: COSMOS
Status last verified: Jan 2015
First submitted: 3 Nov 2011
Last updated: 9 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK, Pockros PJ, Scott JD, Fevery B, Lambrecht T, Ouwerkerk-Mahadevan S, Callewaert K, Symonds WT, Picchio G, Lindsay KL, Beumont M, Jacobson IM. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014 Nov 15;384(9956):1756-65. doi: 10.1016/S0140-6736(14)61036-9. Epub 2014 Jul 28.
PubMed 25078309

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 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects
ClinicalTrials.gov ID: NCT01466790
Acronym / sponsor ID: COSMOS / CR018724
Conditions: Hepatitis C
Keywords: Hepatitis C, TMC435, PSI-7977, GS7977, Ribavirin, HCV, Hep C, Genotype 1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Janssen R&D IrelandIndustry (pharma, biotech, devices)
Collaborators: Gilead Sciences
Study start: Jan 2012
Primary completion: Nov 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 8 Nov 2011 (estimated)
Results: Posted 22 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm 1	Experimental	Drug: TMC435, Drug: PSI-7977 (GS7977), Drug: Ribavirin30 patients will receive TMC435 (150 mg once a day) plus PSI-7977(GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 24 weeks and followed by a 24-week follow-up phase.
Arm 2	Experimental	Drug: TMC435, Drug: PSI-7977 (GS7977)15 patients wiil receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 24 weeks of and followed by a 24-week follow-up phase.
Arm 3	Experimental	Drug: TMC435, Drug: PSI-7977 (GS7977), Drug: Ribavirin30 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 12 weeks and followed by a 36-week follow-up phase.
Arm 4	Experimental	Drug: TMC435, Drug: PSI-7977 (GS7977)15 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 12 weeks and followed by a 36-week follow-up phase.

Who may qualify

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

Key inclusion criteria (7 listed)

Chronic genotype 1 hepatitis C virus (HCV) infection
Plasma HCV RNA of more than 10,000 IU/mL at screening
Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks
Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks and could also be HCV treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of HCV
Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 of the most recent PegIFN/ribavirin therapy

Key exclusion criteria (6 listed)

Has evidence of hepatic decompensation
Has any liver disease of non-HCV etiology
Has an infection/co-infection with non-genotype 1 HCV
Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)
Has a co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TMC435TMC435 will be administered as one oral capsule of 150 mg once a day.	Drug	Arm 1, Arm 2, Arm 3, Arm 4
PSI-7977 (GS7977)Also: GS7977PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.	Drug	Arm 1, Arm 2, Arm 3, Arm 4
RibavirinRibavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).	Drug	Arm 1, Arm 3

Primary outcome

Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
Time frame: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.

6 secondary outcomes

Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
Time frame: Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)
Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
Time frame: Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)
Number of Participants With a Sustained Virologic Response (SVR) at Week 48
Time frame: Week 48
Number of Participants With Viral Breakthrough
Time frame: Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Number of Participants With Inadequate Virologic Response
Time frame: Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Number of Participants With Viral Relapse
Time frame: During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

Results and safety

Results posted to the registry on 22 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	24	20
Cohort 1: TMC435 and PSI-7977 for 24 Weeks	15	14
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	27	27
Cohort 1: TMC435 and PSI-7977 for 12 Weeks	14	14
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	30	27
Cohort 2: TMC435 and PSI-7977 for 24 Weeks	16	16
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	27	26
Cohort 2: TMC435 and PSI-7977 for 12 Weeks	14	13

Primary outcome: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)

Time frame: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks). Number. Unit: Participants

Measure	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks n = 24	Cohort 1: TMC435 and PSI-7977 for 24 Weeks n = 15	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks n = 27	Cohort 1: TMC435 and PSI-7977 for 12 Weeks n = 14	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks n = 30	Cohort 2: TMC435 and PSI-7977 for 24 Weeks n = 16	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks n = 27	Cohort 2: TMC435 and PSI-7977 for 12 Weeks n = 14
Value	19	14	26	13	28	16	25	13

Population analysed: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	3 of 54 (5.6%)	48 of 54 (88.9%)	Not reported
Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks	1 of 31 (3.2%)	25 of 31 (80.6%)	Not reported
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	0 of 54 (0%)	42 of 54 (77.8%)	Not reported
Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks	0 of 28 (0%)	17 of 28 (60.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25078309Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK, Pockros PJ, Scott JD, Fevery B, Lambrecht T, Ouwerkerk-Mahadevan S, Callewaert K, Symonds WT, Picchio G, Lindsay KL, Beumont M, Jacobson IM. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014 Nov 15;384(9956):1756-65. doi: 10.1016/S0140-6736(14)61036-9. Epub 2014 Jul 28.

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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.

Janssen R&D Ireland Clinical Trial study director

Janssen R&D Ireland

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMC435, PSI-7977 (GS7977) and Ribavirin in people with Hepatitis C, run by Janssen R&D Ireland at 23 sites in 2 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 7 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Puerto Rico. 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 22 Oct 2014). 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?

Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (time frame: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)). 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 NCT01466790, 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 9 Feb 2015.