Hepatic InsufficiencyPhase 1NCT01797536

The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)

A Phase 1 study testing Elbasvir in people with Hepatic Insufficiency, run by Merck Sharp & Dohme LLC at 2 sites in United States.

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 evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency
What is being tested?: Elbasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 2 sitesUnited States
Study dates: 6 Mar 2013to 20 Aug 2014
Phase: Phase 1
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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index (BMI) 19 - 40 kg/m^2, inclusive
In good health based on medical history, physical examination, vital signs, and laboratory safety tests
No clinically significant abnormality on electrocardiogram (ECG)
For participants with hepatic insufficiency only, diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any cause
For participants with hepatic insufficiency only, score on the Child-Pugh scale must range from 5 to 6 for mild hepatic insufficiency, from 7 to 9 for moderate hepatic insufficiency, and from 10 to 15 for severe hepatic insufficiency
Females of childbearing potential must be either be sexually inactive (abstinent) for 14 days before study drug administration and throughout the study or be using an acceptable method of birth control

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Females of non-childbearing potential must have undergone sterilization procedures at least 6 months before Study Day 1
Non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse during the study and for 3 months after study drug administration
Ability to swallow multiple capsules

Who cannot join

Previously enrolled in this study
Mentally or legally incapacitated, significant emotional problems at the time of screening or expected during the conduct of the study, or a history of a clinically significant psychiatric disorder over the last 5 years
History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological disease
History of any illness that might confound the results of the study or pose an additional risk to the participant by participating in the study
For participants with hepatic insufficiency only, estimated creatinine clearance (CrCl) ≤30 mL/min based on the Cockcroft-Gault equation at screening
History or presence of drug abuse within the past 2 years

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For healthy participants only, history of alcoholism within the past 2 years
Females who are pregnant or lactating
Positive results for the urine drug screen at screening or check-in
Positive results at screening or history of human immunodeficiency virus (HIV) or untreated hepatitis C virus (HCV); HCV ribonucleic acid (RNA)-negative participants documented to be cured following anti-HCV treatment are eligible
For healthy participants only, positive results at screening for hepatitis B surface antigen (HBsAg)
Use of any drugs or substances known to be strong inhibitors of cytochrome P450 3A4 (CYP3A4) enzymes and/or P-glycoprotein (P-gp) or any inhibitors of organic anion transporting peptide 1B (OATP1B) within 14 days or 5-times the half-life of the product (for healthy participants) or which cannot be discontinued at least 14 days or 5 times the half-life of the product (for hepatic insufficiency participants) before study drug administration and throughout the study
Use of any drugs or substances known to be strong inducers of CYP3A4 enzymes and/or P-gp, including St-John's Wort or rifampin, within 28 days or 5 times the half-life of the product before study drug administration
Currently use of any medication or substance which cannot be discontinued or maintained at a steady dose and regimen at least 14 days before study drug administration and throughout the study
For healthy participants only, on a special diet within 28 days before study drug administration
Blood donation >500 mL or significant blood loss within 56 days before study drug administration
Plasma donation within 7 days before study drug administration
Participation in another clinical study within 28 days before study drug administration

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Call for Information (Investigational Site 0003)
Miami, Florida, 33136
Call for Information (Investigational Site 0001)
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Three-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-8742

Conditions: Hepatic Insufficiency
Being tested: Elbasvir
Medical subject headings: Hepatic Insufficiency

What participants receive

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

ElbasvirDrug

Study groups in NCT01797536
Study group	Role	What they receive
Mild Hepatic Insufficiency	Experimental	Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale Receives: Drug: Elbasvir
Moderate Hepatic Insufficiency	Experimental	Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale Receives: Drug: Elbasvir
Severe Hepatic Insufficiency	Experimental	Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale Receives: Drug: Elbasvir
Healthy Participants	Experimental	Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight Receives: Drug: Elbasvir

What is being measured

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

Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.
Measured: Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168
Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.
Measured: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24
Maximum Concentration (Cmax) of Elbasvir
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.
Measured: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168
Concentration at 24 Hours (C24) After Dosing Elbasvir
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.
Measured: Hour 24
Time to Maximum Concentration (Tmax) of Elbasvir
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.
Measured: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168
Apparent Terminal Half-Life (t1/2) of Elbasvir
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.
Measured: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168

Timeline

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

6 Mar 201320 Aug 2014

First posted22 Feb 2013 (estimated)
Study start6 Mar 2013
Primary completion20 Aug 2014
Study completion20 Aug 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 Hepatic InsufficiencyStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01797536
Sponsor's protocol ID: 8742-009
Status last verified: Sep 2018
First submitted: 20 Feb 2013
Last updated: 25 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Marshall WL, Feng HP, Wenning L, Garrett G, Huang X, Liu F, Panebianco D, Caro L, Fandozzi C, Lasseter KC, Preston RA, Marbury T, Butterton JR, Iwamoto M, Yeh WW. Pharmacokinetics, Safety, and Tolerability of Single-Dose Elbasvir in Participants with Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2018 Jun;43(3):321-329. doi: 10.1007/s13318-017-0451-9.
PubMed 29247332

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?

See locations

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All Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Three-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-8742
ClinicalTrials.gov ID: NCT01797536
Acronym / sponsor ID: 8742-009
Conditions: Hepatic Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Celerion
Study start: 6 Mar 2013 (actual)
Primary completion: 20 Aug 2014 (actual)
Study completion: 20 Aug 2014 (actual)
First posted: 22 Feb 2013 (estimated)
Results: Posted 18 Nov 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Mild Hepatic Insufficiency	Experimental	Drug: ElbasvirSingle oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
Moderate Hepatic Insufficiency	Experimental	Drug: ElbasvirSingle oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
Severe Hepatic Insufficiency	Experimental	Drug: ElbasvirSingle oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
Healthy Participants	Experimental	Drug: ElbasvirSingle oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Body mass index (BMI) 19 - 40 kg/m^2, inclusive
In good health based on medical history, physical examination, vital signs, and laboratory safety tests
No clinically significant abnormality on electrocardiogram (ECG)
For participants with hepatic insufficiency only, diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any cause
For participants with hepatic insufficiency only, score on the Child-Pugh scale must range from 5 to 6 for mild hepatic insufficiency, from 7 to 9 for moderate hepatic insufficiency, and from 10 to 15 for severe hepatic insufficiency

Key exclusion criteria (18 listed)

Previously enrolled in this study
Mentally or legally incapacitated, significant emotional problems at the time of screening or expected during the conduct of the study, or a history of a clinically significant psychiatric disorder over the last 5 years
History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological disease
History of any illness that might confound the results of the study or pose an additional risk to the participant by participating in the study
For participants with hepatic insufficiency only, estimated creatinine clearance (CrCl) ≤30 mL/min based on the Cockcroft-Gault equation at screening

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
Elbasvir	Drug	Healthy Participants, Mild Hepatic Insufficiency, Moderate Hepatic Insufficiency, Severe Hepatic Insufficiency

Primary outcome

Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir
Time frame: Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.
Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir
Time frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.
Maximum Concentration (Cmax) of Elbasvir
Time frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.
Concentration at 24 Hours (C24) After Dosing Elbasvir
Time frame: Hour 24
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.
Time to Maximum Concentration (Tmax) of Elbasvir
Time frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.
Apparent Terminal Half-Life (t1/2) of Elbasvir
Time frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.

Results and safety

Results posted to the registry on 18 Nov 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
Mild Hepatic Insufficiency	8	8
Moderate Hepatic Insufficiency	11	10
Severe Hepatic Insufficiency	7	7
Healthy Participants	8	8

Primary outcome: Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir

Time frame: Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168. Geometric mean (95% Confidence Interval). Unit: μM•hr

Measure	Mild Hepatic Insufficiency n = 8	Moderate Hepatic Insufficiency n = 7	Severe Hepatic Insufficiency n = 7	Healthy Participants n = 8
Value	1.56 (0.95 to 2.57)	1.86 (1.10 to 3.16)	2.28 (1.34 to 3.87)	2.58 (1.58 to 4.24)

Mild Hepatic Insufficiency vs Healthy Participants: Geometric Mean Ratio (GMR): 0.61 (90% CI 0.34 to 1.08)
Moderate Hepatic Insufficiency vs Healthy Participants: GMR: 0.72 (90% CI 0.40 to 1.31)
Severe Hepatic Insufficiency vs Healthy Participants: GMR: 0.88 (90% CI 0.48 to 1.61)

Population analysed: Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.

Primary outcome: Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir

Time frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24. Geometric mean (95% Confidence Interval). Unit: μM•hr

Measure	Mild Hepatic Insufficiency n = 8	Moderate Hepatic Insufficiency n = 7	Severe Hepatic Insufficiency n = 7	Healthy Participants n = 8
Value	0.87 (0.54 to 1.41)	0.92 (0.55 to 1.55)	0.92 (0.55 to 1.54)	1.45 (0.90 to 2.35)

Mild Hepatic Insufficiency vs Healthy Participants: GMR: 0.60 (90% CI 0.34 to 1.05)
Moderate Hepatic Insufficiency vs Healthy Participants: GMR: 0.64 (90% CI 0.35 to 1.14)
Severe Hepatic Insufficiency vs Healthy Participants: GMR: 0.63 (90% CI 0.35 to 1.13)

Primary outcome: Maximum Concentration (Cmax) of Elbasvir

Time frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Mild Hepatic Insufficiency n = 8	Moderate Hepatic Insufficiency n = 8	Severe Hepatic Insufficiency n = 7	Healthy Participants n = 8
Value	70.1 (42.3 to 116.0)	83.0 (50.1 to 137.0)	70.7 (41.3 to 121.0)	121.0 (73.1 to 200.0)

Mild Hepatic Insufficiency vs Healthy Participants: GMR: 0.58 (90% CI 0.32 to 1.05)
Moderate Hepatic Insufficiency vs Healthy Participants: GMR: 0.64 (90% CI 0.35 to 1.14)
Severe Hepatic Insufficiency vs Healthy Participants: GMR: 0.58 (90% CI 0.32 to 1.08)

Primary outcome: Concentration at 24 Hours (C24) After Dosing Elbasvir

Time frame: Hour 24. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Mild Hepatic Insufficiency n = 8	Moderate Hepatic Insufficiency n = 7	Severe Hepatic Insufficiency n = 7	Healthy Participants n = 8
Value	22.9 (14.0 to 37.5)	25.9 (15.3 to 43.9)	29.6 (17.4 to 50.1)	37.7 (23.0 to 61.7)

Mild Hepatic Insufficiency vs Healthy Participants: GMR: 0.61 (90% CI 0.34 to 1.08)
Moderate Hepatic Insufficiency vs Healthy Participants: GMR: 0.69 (90% CI 0.38 to 1.25)
Severe Hepatic Insufficiency vs Healthy Participants: GMR: 0.78 (90% CI 0.43 to 1.43)

Adverse events

Time frame: up to 14 days post-dose (total of 14 days for each panel). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild Hepatic Insufficiency	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Moderate Hepatic Insufficiency	1 of 11 (9.1%)	3 of 11 (27.3%)	Not reported
Severe Hepatic Insufficiency	0 of 7 (0%)	0 of 7 (0%)	Not reported
Healthy Participants	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29247332Marshall WL, Feng HP, Wenning L, Garrett G, Huang X, Liu F, Panebianco D, Caro L, Fandozzi C, Lasseter KC, Preston RA, Marbury T, Butterton JR, Iwamoto M, Yeh WW. Pharmacokinetics, Safety, and Tolerability of Single-Dose Elbasvir in Participants with Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2018 Jun;43(3):321-329. doi: 10.1007/s13318-017-0451-9.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elbasvir in people with Hepatic Insufficiency, run by Merck Sharp & Dohme LLC at 2 sites in United States.

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 9 inclusion and 18 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Nov 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?

Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir (time frame: Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168). The study lists 6 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 NCT01797536, 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 25 Oct 2018.