Hepatitis C, ChronicPhase 2PEARL-INCT01685203

A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection

A Phase 2 study testing ABT-450/r, ABT-267 and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by AbbVie (prior sponsor, Abbott).

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 safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: ABT-450/r, ABT-267 and Ribavirin (RBV)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 316 participants
Where: No sites listed yet
Study dates: Aug 2012to Feb 2015
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

Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
Subjects must meet one of the following:
Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.
Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Who cannot join

History of severe, life-threatening or other significant sensitivity to any drug.
Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.

About this study

Official title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)

Read the detailed description

This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis. Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other groups completed the study.

Conditions: Hepatitis C, Chronic
Being tested: ABT-450/r, ABT-267, Ribavirin (RBV)
Keywords: Hepatitis C Virus, Ribavirin-Free, Hepatitis C Genotype 1, Hepatitis C, Interferon-Free, Chronic Hepatitis C, Compensated cirrhosis, Hepatitis C Genotype 4, Paritaprevir, Ombitasvir, Ritonavir, Ribavirin
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

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

ABT-450/rDrug
Also called ABT-450 also known as paritaprevir
Tablet; ABT-450; Capsule; ritonavir
ABT-267Drug
Also called ABT-267 also known as ombitasvir
Tablet
Ribavirin (RBV)Drug
Tablet

Study groups in NCT01685203
Study group	Role	What they receive
Group 1	Experimental	ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants Receives: Drug: ABT-450/r; Drug: ABT-267
Group 2	Experimental	ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants Receives: Drug: ABT-450/r; Drug: ABT-267
Group 3	Experimental	ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants Receives: Drug: ABT-450/r; Drug: ABT-267
Group 4	Experimental	ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants Receives: Drug: ABT-450/r; Drug: ABT-267; Drug: Ribavirin (RBV)
Group 5	Experimental	ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants Receives: Drug: ABT-450/r; Drug: ABT-267
Group 6	Experimental	ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants Receives: Drug: ABT-450/r; Drug: ABT-267; Drug: Ribavirin (RBV)
Group 7	Experimental	ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis Receives: Drug: ABT-450/r; Drug: ABT-267
Group 8	Experimental	ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis Receives: Drug: ABT-450/r; Drug: ABT-267

What is being measured

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

Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.
Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (4)

Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.
Measured: 24 weeks after the last actual dose of study drug
Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
Measured: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Measured: Within 12 weeks after the last dose of study drug
Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.
Measured: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.

Timeline

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

Aug 2012Feb 2015

First posted14 Sep 2012 (estimated)
Study startAug 2012
Primary completionJun 2014
Study completionFeb 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis C, ChronicStudies 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: 316 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01685203
Sponsor's protocol ID: M13-393
Other IDs: 2011-005762-38
Acronym: PEARL-I
Status last verified: Jul 2021
First submitted: 12 Sep 2012
Last updated: 30 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.
PubMed 25837829
Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hezode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology. 2015 Oct;149(4):971-80.e1. doi: 10.1053/j.gastro.2015.07.001. Epub 2015 Jul 11.
PubMed 26170136

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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Hepatitis C, Chronic, Pregnancy; Infection
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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)
ClinicalTrials.gov ID: NCT01685203
Acronym / sponsor ID: PEARL-I / M13-393
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C Virus, Ribavirin-Free, Hepatitis C Genotype 1, Hepatitis C, Interferon-Free, Chronic Hepatitis C, Compensated cirrhosis, Hepatitis C Genotype 4
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 316 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Jun 2014 (actual)
Study completion: Feb 2015 (actual)
First posted: 14 Sep 2012 (estimated)
Results: Posted 4 Aug 2015

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: 8

Arm	Type	Receives
Group 1	Experimental	Drug: ABT-450/r, Drug: ABT-267ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Group 2	Experimental	Drug: ABT-450/r, Drug: ABT-267ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
Group 3	Experimental	Drug: ABT-450/r, Drug: ABT-267ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
Group 4	Experimental	Drug: ABT-450/r, Drug: ABT-267, Drug: Ribavirin (RBV)ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Group 5	Experimental	Drug: ABT-450/r, Drug: ABT-267ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants
Group 6	Experimental	Drug: ABT-450/r, Drug: ABT-267, Drug: Ribavirin (RBV)ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
Group 7	Experimental	Drug: ABT-450/r, Drug: ABT-267ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
Group 8	Experimental	Drug: ABT-450/r, Drug: ABT-267ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis

Who may qualify

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

Key inclusion criteria (7 listed)

Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
Subjects must meet one of the following:
Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.
Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Key exclusion criteria (4 listed)

History of severe, life-threatening or other significant sensitivity to any drug.
Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.

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
ABT-450/rAlso: ABT-450 also known as paritaprevirTablet; ABT-450; Capsule; ritonavir	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8
ABT-267Also: ABT-267 also known as ombitasvirTablet	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8
Ribavirin (RBV)Tablet	Drug	Group 4, Group 6

Primary outcome

Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
Time frame: 12 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.

4 secondary outcomes

Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
Time frame: 24 weeks after the last actual dose of study drug
Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
Time frame: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
Time frame: Within 12 weeks after the last dose of study drug
Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
Time frame: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.

Results and safety

Results posted to the registry on 4 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	44	40
Group 2	42	39
Group 3	40	40
Group 4	42	41
Group 6	49	49
Group 7	47	44
Group 8	52	52

Primary outcome: Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment

Time frame: 12 weeks after the last actual dose of study drug. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 n = 44	Group 2 n = 42	Group 3 n = 40	Group 4 n = 42	Group 6 n = 49	Group 7 n = 47	Group 8 n = 52
Value	90.9 (78.3 to 97.5)	95.2 (83.8 to 99.4)	90.0 (76.3 to 97.2)	100 (91.6 to 100.0)	100 (92.7 to 100.0)	97.9 (88.7 to 99.9)	98.1 (89.7 to 100.0)

Group 2 vs Group 3: p = 0.381, Regression, Logistic
Group 1 vs Group 4: p = 0.086, Stratum-adjusted Mantel-Haenszel

Population analysed: All randomized participants who received at least 1 dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	2 of 44 (4.5%)	30 of 44 (68.2%)	Not reported
Group 2	1 of 42 (2.4%)	24 of 42 (57.1%)	Not reported
Group 3	1 of 40 (2.5%)	26 of 40 (65%)	Not reported
Group 4	0 of 42 (0%)	32 of 42 (76.2%)	Not reported
Group 6	0 of 49 (0%)	38 of 49 (77.6%)	Not reported
Group 7	3 of 47 (6.4%)	34 of 47 (72.3%)	Not reported
Group 8	2 of 52 (3.8%)	33 of 52 (63.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25837829Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.
Background: PubMed 26170136Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hezode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology. 2015 Oct;149(4):971-80.e1. doi: 10.1053/j.gastro.2015.07.001. Epub 2015 Jul 11.
Related InfoLink provided by the sponsor.

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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.

Nilou Mobashery, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-450/r, ABT-267 and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by AbbVie (prior sponsor, Abbott).

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 4 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 30 Jul 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 4 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment (time frame: 12 weeks after the last actual dose of study drug). 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 NCT01685203, which also lists 2 linked publications.

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 30 Jul 2021.