Hepatitis C, ChronicPhase 3NCT01390844

Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

A Phase 3 study testing Boceprevir (BOC), Peginterferon alfa-2b (PEG) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Boceprevir (BOC), Peginterferon alfa-2b (PEG) and Ribavirin (RBV)
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: 282 participants
Where: No sites listed yet
Study dates: 21 Oct 2011to 19 Jun 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
Liver biopsy with histology consistent with CHC and no other etiology.
Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
Weight between 40 kg and 125 kg, inclusive
Of 'local' ancestral descent
Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

Who cannot join

Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.

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Diabetes and/or hypertension with clinically significant ocular examination findings.
Any condition the could interfere with participation in and completion of the trial.
Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
Pregnant or breast-feeding.

About this study

Official title: Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

Conditions: Hepatitis C, Chronic
Being tested: Boceprevir (BOC), Placebo to boceprevir, Peginterferon alfa-2b (PEG), Ribavirin (RBV), Cross-Over Boceprevir Treatment
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

Boceprevir (BOC)Drug
Also called SCH 503034, Victrelis
200 mg capsules, 800 mg three times daily by mouth
Placebo to boceprevirDrug
200 mg placebo capsules, 800 mg three times daily by mouth
Peginterferon alfa-2b (PEG)Drug
Also called PegIntron, SCH 054031, Redipen
1.5 mcg/kg/week subcutaneously
Ribavirin (RBV)Drug
Also called Rebetol, SCH 018908
200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
Cross-Over Boceprevir TreatmentDrug
Also called SCH 503034, Victrelis
At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Study groups in NCT01390844
Study group	Role	What they receive
Boceprevir	Experimental	PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up. Receives: Drug: Boceprevir (BOC); Drug: Placebo to boceprevir; Drug: Peginterferon alfa-2b (PEG); Drug: Ribavirin (RBV)
Control	Active comparator	PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14. Receives: Drug: Placebo to boceprevir; Drug: Peginterferon alfa-2b (PEG); Drug: Ribavirin (RBV); Drug: Cross-Over Boceprevir Treatment

What is being measured

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

Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population
SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Measured: Follow-up Week 24
Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Measured: Follow-up Week 24

Secondary outcomes (8)

Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Measured: Follow-up Week 24
Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Measured: Follow-up Week 24
Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8
Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)
Measured: Treatment Week 8
Percentage of Participants in India Achieving EVR at Treatment Week 8
Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)
Measured: Treatment Week 8
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).
Measured: Up to 96 weeks
Percentage of Participants With an AE of Anemia in India
Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).
Measured: Up to 96 weeks
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.
Measured: Up to 96 weeks
Percentage of Participants With an AE of Neutropenia in India
Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.
Measured: Up to 96 weeks

Timeline

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

21 Oct 201119 Jun 2015

First posted11 Jul 2011 (estimated)
Study start21 Oct 2011
Primary completion19 Jun 2015
Study completion19 Jun 2015

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 C, ChronicStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01390844
Sponsor's protocol ID: P07063
Other IDs: 2007-005151-42, 3034-033, CTRI/2012/04/002540
Status last verified: Aug 2018
First submitted: 7 Jul 2011
Last updated: 11 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin
ClinicalTrials.gov ID: NCT01390844
Acronym / sponsor ID: P07063
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Oct 2011 (actual)
Primary completion: 19 Jun 2015 (actual)
Study completion: 19 Jun 2015 (actual)
First posted: 11 Jul 2011 (estimated)
Results: Posted 28 Jun 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Boceprevir	Experimental	Drug: Boceprevir (BOC), Drug: Placebo to boceprevir, Drug: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV)PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
Control	Active comparator	Drug: Placebo to boceprevir, Drug: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Cross-Over Boceprevir TreatmentPEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.

Who may qualify

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

Key inclusion criteria (7 listed)

Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
Liver biopsy with histology consistent with CHC and no other etiology.
Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
Weight between 40 kg and 125 kg, inclusive

Key exclusion criteria (10 listed)

Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.

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
Boceprevir (BOC)Also: SCH 503034, Victrelis200 mg capsules, 800 mg three times daily by mouth	Drug	Boceprevir
Placebo to boceprevir200 mg placebo capsules, 800 mg three times daily by mouth	Drug	Boceprevir, Control
Peginterferon alfa-2b (PEG)Also: PegIntron, SCH 054031, Redipen1.5 mcg/kg/week subcutaneously	Drug	Boceprevir, Control
Ribavirin (RBV)Also: Rebetol, SCH 018908200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily	Drug	Boceprevir, Control
Cross-Over Boceprevir TreatmentAlso: SCH 503034, VictrelisAt Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.	Drug	Control

Primary outcome

Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population
Time frame: Follow-up Week 24
SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population
Time frame: Follow-up Week 24
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

8 secondary outcomes

Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population
Time frame: Follow-up Week 24
Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population
Time frame: Follow-up Week 24
Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8
Time frame: Treatment Week 8
Percentage of Participants in India Achieving EVR at Treatment Week 8
Time frame: Treatment Week 8
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Time frame: Up to 96 weeks
Percentage of Participants With an AE of Anemia in India
Time frame: Up to 96 weeks
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Time frame: Up to 96 weeks
Percentage of Participants With an AE of Neutropenia in India
Time frame: Up to 96 weeks

Results and safety

Results posted to the registry on 28 Jun 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
Boceprevir - Korea+Taiwan	133	93
Control - Korea+Taiwan	65	37
Boceprevir - India	57	26
Control - India	27	8

Primary outcome: Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population

Time frame: Follow-up Week 24. Number. Unit: Percentage of Participants

Measure	Boceprevir - Korea+Taiwan n = 133	Control - Korea+Taiwan n = 65
Value	60.90	26.15

Boceprevir - Korea+Taiwan vs Control - Korea+Taiwan: Difference in Percentage: 34.63 (95% CI 20.24 to 47.18), p <0.0001, Miettinen and Numinen

Population analysed: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).

Primary outcome: Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population

Time frame: Follow-up Week 24. Number. Unit: Percentage of Participants

Measure	Boceprevir - India n = 47	Control - India n = 24
Value	53.19	20.83

Boceprevir - India vs Control - India: Difference in Percentage: 33.83 (95% CI 10.15 to 52.18), p = 0.0063, Miettinen and Numinen

Population analysed: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 96 weeks (including up to 38 weeks of follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boceprevir - Korea + Taiwan	16 of 133 (12%)	131 of 133 (98.5%)	Not reported
Control - Korea + Taiwan	3 of 65 (4.6%)	62 of 65 (95.4%)	Not reported
Boceprevir - India	0 of 47 (0%)	44 of 47 (93.6%)	Not reported
Control - India	2 of 24 (8.3%)	15 of 24 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C, Chronic

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boceprevir (BOC), Peginterferon alfa-2b (PEG) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

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 10 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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 28 Jun 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 in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population (time frame: Follow-up Week 24). The study lists 2 primary outcomes in all. 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 NCT01390844.

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 11 Sep 2018.