Hepatitis CPhase 2NCT02133131

Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

A Phase 2 study testing Grazoprevir/Elbasvir FDC and Sofosbuvir in people with Hepatitis C, 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

Search all trials

Trial summary

This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: Grazoprevir/Elbasvir FDC and Sofosbuvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: No sites listed yet
Study dates: 13 Jun 2014to 1 Feb 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening
has documented chronic HCV GT1 or GT3 infection
has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
is treatment naïve to all anti-HCV treatment

Who cannot join

has evidence of decompensated liver disease
is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
has clinically-relevant drug or alcohol abuse within 12 months of screening
has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
has a history of chronic hepatitis not caused by HCV

About this study

Official title: A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection

Read the detailed description

The study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination [FDC] of grazoprevir 100mg + elbasvir 50mg, and SOF 400mg, in treatment-naive participants with chronic HCV GT1 or GT3. The impact of study treatment regimens of varying duration on SVR12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) in cirrhotic (C) participants and non-cirrhotic (NC) participants will be determined (Part A). Any HCV GT1 participant from study Arms 1-4 in Part A who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with MK-5172/MK-8742 + SOF + ribavirin and 24 weeks of follow-up in Part B.

Conditions: Hepatitis C
Being tested: Grazoprevir/Elbasvir FDC, Sofosbuvir
Medical subject headings: Hepatitis C

What participants receive

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

Grazoprevir/Elbasvir FDCDrug
Also called MK-5172A, Zepatier
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
SofosbuvirDrug
Sofosbuvir 400mg tablet taken q.d. by mouth.

Study groups in NCT02133131
Study group	Role	What they receive
GT1:NC Grazoprevir/Elbasvir+SOF 4wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC with SOF 400mg once daily (q.d.) by mouth for 4 weeks (n=30 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir
GT1:NC Grazoprevir/Elbasvir+SOF 6wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=30 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir
GT1:C Grazoprevir/Elbasvir+SOF 6wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=20 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir
GT1:C Grazoprevir/Elbasvir+SOF 8wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=20 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir
GT3:NC Grazoprevir/Elbasvir+SOF 8wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=15 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir
GT3:NC Grazoprevir/Elbasvir+SOF 12wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=15 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir
GT3:C Grazoprevir/Elbasvir+SOF 12wk	Experimental	Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=10 planned). Receives: Drug: Grazoprevir/Elbasvir FDC; Drug: Sofosbuvir

What is being measured

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

Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Measured: Up to 24 weeks
Number of Participants Experiencing at Least 1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Week 14
Number of Participants Discontinuing Study Therapy Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Week 12

Secondary outcomes (1)

Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)
The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Measured: Up to 16 weeks

Timeline

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

13 Jun 20141 Feb 2016

First posted7 May 2014 (estimated)
Study start13 Jun 2014
Primary completion2 Nov 2015
Study completion1 Feb 2016

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02133131
Sponsor's protocol ID: 5172-074
Status last verified: Jan 2021
First submitted: 5 May 2014
Last updated: 5 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Lawitz E, Poordad F, Gutierrez JA, Wells JT, Landaverde CE, Evans B, Howe A, Huang HC, Li JJ, Hwang P, Dutko FJ, Robertson M, Wahl J, Barr E, Haber B. Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2017 Feb;65(2):439-450. doi: 10.1002/hep.28877. Epub 2016 Dec 19.
PubMed 27770561

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

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HCV Infection
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection
ClinicalTrials.gov ID: NCT02133131
Acronym / sponsor ID: 5172-074
Conditions: Hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 13 Jun 2014 (actual)
Primary completion: 2 Nov 2015 (actual)
Study completion: 1 Feb 2016 (actual)
First posted: 7 May 2014 (estimated)
Results: Posted 17 Nov 2016

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: 7

Arm	Type	Receives
GT1:NC Grazoprevir/Elbasvir+SOF 4wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC with SOF 400mg once daily (q.d.) by mouth for 4 weeks (n=30 planned).
GT1:NC Grazoprevir/Elbasvir+SOF 6wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=30 planned).
GT1:C Grazoprevir/Elbasvir+SOF 6wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=20 planned).
GT1:C Grazoprevir/Elbasvir+SOF 8wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=20 planned).
GT3:NC Grazoprevir/Elbasvir+SOF 8wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=15 planned).
GT3:NC Grazoprevir/Elbasvir+SOF 12wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=15 planned).
GT3:C Grazoprevir/Elbasvir+SOF 12wk	Experimental	Drug: Grazoprevir/Elbasvir FDC, Drug: SofosbuvirParticipants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=10 planned).

Who may qualify

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

Key inclusion criteria (4 listed)

has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening
has documented chronic HCV GT1 or GT3 infection
has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
is treatment naïve to all anti-HCV treatment

Key exclusion criteria (7 listed)

has evidence of decompensated liver disease
is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
has clinically-relevant drug or alcohol abuse within 12 months of 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
Grazoprevir/Elbasvir FDCAlso: MK-5172A, ZepatierFDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.	Drug	GT1:C Grazoprevir/Elbasvir+SOF 6wk, GT1:C Grazoprevir/Elbasvir+SOF 8wk, GT1:NC Grazoprevir/Elbasvir+SOF 4wk, GT1:NC Grazoprevir/Elbasvir+SOF 6wk, GT3:C Grazoprevir/Elbasvir+SOF 12wk, GT3:NC Grazoprevir/Elbasvir+SOF 12wk, GT3:NC Grazoprevir/Elbasvir+SOF 8wk
SofosbuvirSofosbuvir 400mg tablet taken q.d. by mouth.	Drug	GT1:C Grazoprevir/Elbasvir+SOF 6wk, GT1:C Grazoprevir/Elbasvir+SOF 8wk, GT1:NC Grazoprevir/Elbasvir+SOF 4wk, GT1:NC Grazoprevir/Elbasvir+SOF 6wk, GT3:C Grazoprevir/Elbasvir+SOF 12wk, GT3:NC Grazoprevir/Elbasvir+SOF 12wk, GT3:NC Grazoprevir/Elbasvir+SOF 8wk

Primary outcome

Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
Time frame: Up to 24 weeks
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Number of Participants Experiencing at Least 1 Adverse Event (AE)
Time frame: Up to Week 14
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Discontinuing Study Therapy Due to an AE
Time frame: Up to Week 12
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

1 secondary outcome

Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)
Time frame: Up to 16 weeks

Results and safety

Results posted to the registry on 17 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
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks	31	26
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks	30	25
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks	20	19
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks	21	15
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks	15	0
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks	14	0
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks	12	0

Primary outcome: Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)

Time frame: Up to 24 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks n = 30	GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks n = 28	GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks n = 20	GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks n = 19	GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks n = 15	GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks n = 14	GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks n = 11
Value	33.3 (17.3 to 52.8)	89.3 (71.8 to 97.7)	80.0 (56.3 to 94.3)	89.5 (66.9 to 98.7)	93.3 (68.1 to 99.8)	100.0 (76.8 to 100.00)	90.9 (58.7 to 99.8)

Population analysed: The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.

Primary outcome: Number of Participants Experiencing at Least 1 Adverse Event (AE)

Time frame: Up to Week 14. Number. Unit: Number of participants

Measure	GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks n = 31	GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks n = 30	GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks n = 20	GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks n = 21	GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks n = 15	GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks n = 14	GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks n = 12
Value	5	7	7	4	4	3	3

Population analysed: The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.

Primary outcome: Number of Participants Discontinuing Study Therapy Due to an AE

Time frame: Up to Week 12. Number. Unit: Number of participants

Measure	GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks n = 31	GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks n = 30	GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks n = 20	GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks n = 21	GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks n = 15	GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks n = 14	GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks n = 12
Value	0	0	0	1	0	0	0

Population analysed: The APaT population consists of all participants who received ≥1 dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks	0 of 31 (0%)	2 of 31 (6.5%)	Not reported
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks	0 of 30 (0%)	2 of 30 (6.7%)	Not reported
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks	1 of 20 (5%)	2 of 20 (10%)	Not reported
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks	1 of 21 (4.8%)	4 of 21 (19%)	Not reported
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks	1 of 15 (6.7%)	4 of 15 (26.7%)	Not reported
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks	1 of 12 (8.3%)	3 of 12 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27770561Lawitz E, Poordad F, Gutierrez JA, Wells JT, Landaverde CE, Evans B, Howe A, Huang HC, Li JJ, Hwang P, Dutko FJ, Robertson M, Wahl J, Barr E, Haber B. Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2017 Feb;65(2):439-450. doi: 10.1002/hep.28877. Epub 2016 Dec 19.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Grazoprevir/Elbasvir FDC and Sofosbuvir in people with Hepatitis C, 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 4 inclusion and 7 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 5 Feb 2021. 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 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 17 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?

Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12) (time frame: Up to 24 weeks). The study lists 3 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 NCT02133131, 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 5 Feb 2021.