MalariaPhase 2NCT03334747

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

A Phase 2 study testing KAE609 and Coartem in people with Malaria, run by Novartis Pharmaceuticals at 9 sites in 5 countries.

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

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malaria
What is being tested?: KAE609 and Coartem
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 188 participants
Where: 9 sitesin 5 countries
Study dates: 16 Nov 2017to 23 Nov 2019
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

Male and female patients ≥ 18 years with a body weight ≥ 45 kg.
Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.

Who cannot join

Mixed Plasmodium infections.
Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
Clinical or laboratory evidence of any of the following:
AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
AST/ALT > 1.0 and ≤ 1.5 x ULN and total bilirubin is > ULN

Show all 12Show fewer

Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
History of photodermatitis/increased sensitivity to sun.
Pregnant or nursing (lactating) women.
Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.
Moderate to severe anemia (Hemoglobin level <8 g/dL).
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

9 sites in 5 countries.

Country

City, postcode or hospital

9 sites in 5 countries

Uganda3 sites

Novartis Investigative Site
Bushenyi
Novartis Investigative Site
Kampala
Novartis Investigative Site
Tororo

Other trials in Uganda

Ghana2 sites

Novartis Investigative Site
Kintampo
Novartis Investigative Site
Navrango

Other trials in Ghana

Mali2 sites

Novartis Investigative Site
Bamako
Novartis Investigative Site
Sotouba

Other trials in Mali

Gabon1 site

Novartis Investigative Site
Lambaréné

Other trials in Gabon

Rwanda1 site

Novartis Investigative Site
Kigali

Other trials in Rwanda

About this study

Official title: A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria.

Conditions: Malaria
Being tested: KAE609, Coartem
Keywords: uncomplicated Plasmodium falciparum Malaria.
Medical subject headings: Malaria

What participants receive

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

KAE609Drug
Also called Cipargamin
Exploration of different doses of KAE609 to establish safety profile.
CoartemDrug
Also called Artemether Lumefantrine
Control Arm

Study groups in NCT03334747
Study group	Role	What they receive
Treatment arm 1: KAE609 10 mg Single Dose (SD)	Experimental	KAE609 10 mg once daily (QD) for 1 day Receives: Drug: KAE609
Treatment arm 2:KAE609 25 mg SD	Experimental	KAE609 25 mg once daily (QD) for 1 day Receives: Drug: KAE609
Treatment arm 3:KAE609 10 mg 3 Days	Experimental	KAE609 10 mg (QD) for 3 days Receives: Drug: KAE609
Treatment arm 4:KAE609 50 mg SD	Experimental	KAE609 50 mg once daily (QD) for 1 day Receives: Drug: KAE609
Treatment arm 5:KAE609 25 mg 3 Days	Experimental	KAE609 25 mg once daily (QD) for 3 days Receives: Drug: KAE609
Treatment arm 6:KAE609 75 mg SD	Experimental	KAE609 75 mg once daily (QD) for 1 day Receives: Drug: KAE609
Treatment arm 7:KAE609 50 mg 3 Days	Experimental	KAE609 50 mg once daily (QD) for 3 days Receives: Drug: KAE609
Treatment arm 8: KAE609 150 mg SD	Experimental	KAE609 150 mg once daily (QD) for 1 day Receives: Drug: KAE609
Treatment arm 9: Coartem Control	Active comparator	Coartem® control Receives: Drug: Coartem

What is being measured

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

Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
Measured: Day 29

Secondary outcomes (8)

Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.
Measured: Day 15, Day 29
Parasite Clearance Time (PCT)
Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
Measured: Day 29
Fever Clearance Time (FCT)
Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
Measured: Day 29
Time to Recrudescence and Reinfection at Study Day 29
Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.
Measured: Day 29
Maximum Peak Observed Concentration (Cmax)
Maximum Peak Observed Concentration (Cmax)
Measured: Day 1, Day 3
Tmax
Tmax
Measured: Day 1, Day 3
AUC0-24
AUC0-24
Measured: Day 1, Day 3
Half-life (T^1/2)
Half-life (T^1/2)
Measured: Upto day 15 post dose

Timeline

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

16 Nov 201723 Nov 2019

First posted7 Nov 2017
Study start16 Nov 2017
Primary completion23 Nov 2019
Study completion23 Nov 2019

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 MalariaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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
Model description: Patients were randomized to KAE609 and Coartem in parallel treatment arms. Increasing doses of KAE609 (single dose and multiple dose) were evaluated in dose escalated manner in sequential cohorts
Masking: None (open label)
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03334747
Sponsor's protocol ID: CKAE609A2202
Other IDs: 207813/Z/17/Z
Status last verified: Oct 2021
First submitted: 27 Oct 2017
Last updated: 11 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Jain JP, Barsainya S, Kullak-Ublick GA, Su G, Schmitt EK, Csermak K, Gandhi P, Hughes D. Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa. Malar J. 2021 Dec 20;20(1):478. doi: 10.1186/s12936-021-04009-1.
PubMed 34930267
Schmitt EK, Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Su G, Csermak Renner K, Venishetty VK, Sayyed S, Straimer J, Demin I, Barsainya S, Boulton C, Gandhi P. Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated Plasmodium falciparum Malaria. Clin Infect Dis. 2022 May 30;74(10):1831-1839. doi: 10.1093/cid/ciab716.
PubMed 34410358

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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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria.
ClinicalTrials.gov ID: NCT03334747
Acronym / sponsor ID: CKAE609A2202
Conditions: Malaria
Keywords: uncomplicated Plasmodium falciparum Malaria.
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Wellcome Trust
Study start: 16 Nov 2017 (actual)
Primary completion: 23 Nov 2019 (actual)
Study completion: 23 Nov 2019 (actual)
First posted: 7 Nov 2017 (actual)
Results: Posted 25 Sep 2020

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: None (open label)
Number of arms: 9
Model description: Patients were randomized to KAE609 and Coartem in parallel treatment arms. Increasing doses of KAE609 (single dose and multiple dose) were evaluated in dose escalated manner in sequential cohorts

Arm	Type	Receives
Treatment arm 1: KAE609 10 mg Single Dose (SD)	Experimental	Drug: KAE609KAE609 10 mg once daily (QD) for 1 day
Treatment arm 2:KAE609 25 mg SD	Experimental	Drug: KAE609KAE609 25 mg once daily (QD) for 1 day
Treatment arm 3:KAE609 10 mg 3 Days	Experimental	Drug: KAE609KAE609 10 mg (QD) for 3 days
Treatment arm 4:KAE609 50 mg SD	Experimental	Drug: KAE609KAE609 50 mg once daily (QD) for 1 day
Treatment arm 5:KAE609 25 mg 3 Days	Experimental	Drug: KAE609KAE609 25 mg once daily (QD) for 3 days
Treatment arm 6:KAE609 75 mg SD	Experimental	Drug: KAE609KAE609 75 mg once daily (QD) for 1 day
Treatment arm 7:KAE609 50 mg 3 Days	Experimental	Drug: KAE609KAE609 50 mg once daily (QD) for 3 days
Treatment arm 8: KAE609 150 mg SD	Experimental	Drug: KAE609KAE609 150 mg once daily (QD) for 1 day
Treatment arm 9: Coartem Control	Active comparator	Drug: CoartemCoartem® control

Who may qualify

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

Key inclusion criteria (5 listed)

Male and female patients ≥ 18 years with a body weight ≥ 45 kg.
Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.

Key exclusion criteria (12 listed)

Mixed Plasmodium infections.
Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
Clinical or laboratory evidence of any of the following:
AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin

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
KAE609Also: CipargaminExploration of different doses of KAE609 to establish safety profile.	Drug	Treatment arm 1: KAE609 10 mg Single Dose (SD), Treatment arm 2:KAE609 25 mg SD, Treatment arm 3:KAE609 10 mg 3 Days, Treatment arm 4:KAE609 50 mg SD, Treatment arm 5:KAE609 25 mg 3 Days, Treatment arm 6:KAE609 75 mg SD, Treatment arm 7:KAE609 50 mg 3 Days, Treatment arm 8: KAE609 150 mg SD
CoartemAlso: Artemether LumefantrineControl Arm	Drug	Treatment arm 9: Coartem Control

Primary outcome

Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
Time frame: Day 29
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.

8 secondary outcomes

Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
Time frame: Day 15, Day 29
Parasite Clearance Time (PCT)
Time frame: Day 29
Fever Clearance Time (FCT)
Time frame: Day 29
Time to Recrudescence and Reinfection at Study Day 29
Time frame: Day 29
Maximum Peak Observed Concentration (Cmax)
Time frame: Day 1, Day 3
Tmax
Time frame: Day 1, Day 3
AUC0-24
Time frame: Day 1, Day 3
Half-life (T^1/2)
Time frame: Upto day 15 post dose

Results and safety

Results posted to the registry on 25 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KAE609 10 mg SD	10	9
KAE609 10 mg QD 3 Days	10	10
KAE609 25 mg SD	12	12
KAE609 25 mg QD 3 Days	20	20
KAE609 50 mg SD	22	21
KAE609 50 mg QD 3 Days	20	19
KAE609 75 mg SD	21	21
KAE609 150 mg SD	22	22
Pooled Coartem Control	51	51

Primary outcome: Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)

Time frame: Day 29. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	KAE609 10 mg SD n = 9	KAE609 10 mg QD 3 Days n = 10	KAE609 25 mg SD n = 12	KAE609 25 mg QD 3 Days n = 20	KAE609 50 mg SD n = 21	KAE609 50 mg QD 3 Days n = 19	KAE609 75 mg SD n = 21	KAE609 150 mg SD n = 22	Pooled Coartem Control n = 51
Value	11.1 (0.3 to 48.2)	0 (0.0 to 30.8)	0 (0.0 to 26.5)	0 (0.0 to 16.8)	0 (0.0 to 16.1)	0 (0.0 to 17.6)	0 (0.0 to 16.1)	4.5 (0.1 to 22.8)	3.9 (0.5 to 13.5)

KAE609 10 mg SD: p = 0.391, Fisher Exact
KAE609 10 mg QD 3 Days: p = 1, Fisher Exact
KAE609 25 mg SD: p = 1, Fisher Exact

Population analysed: Safety Set (SAF). Only participants with baseline and at least one post-baseline assessment for either ALT or AST are included in the analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KAE609 10mg SD	0 of 10 (0%)	9 of 10 (90%)	0 of 10
KAE609 10mg QD@3 Days	0 of 10 (0%)	8 of 10 (80%)	0 of 10
KAE609 25mg SD	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
KAE609 25mg QD@3 Days	0 of 20 (0%)	10 of 20 (50%)	0 of 20
KAE609 50mg SD	0 of 21 (0%)	9 of 21 (42.9%)	0 of 21
KAE609 50mg QD@3 Days	1 of 19 (5.3%)	16 of 19 (84.2%)	0 of 19
KAE609 75mg SD	2 of 21 (9.5%)	15 of 21 (71.4%)	0 of 21
KAE609 150mg SD	1 of 22 (4.5%)	12 of 22 (54.5%)	0 of 22
Pooled Coartem	1 of 51 (2%)	25 of 51 (49%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34930267Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Jain JP, Barsainya S, Kullak-Ublick GA, Su G, Schmitt EK, Csermak K, Gandhi P, Hughes D. Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa. Malar J. 2021 Dec 20;20(1):478. doi: 10.1186/s12936-021-04009-1.
Derived from this study: PubMed 34410358Schmitt EK, Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Su G, Csermak Renner K, Venishetty VK, Sayyed S, Straimer J, Demin I, Barsainya S, Boulton C, Gandhi P. Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated Plasmodium falciparum Malaria. Clin Infect Dis. 2022 May 30;74(10):1831-1839. doi: 10.1093/cid/ciab716.
A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

9 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KAE609 and Coartem in people with Malaria, run by Novartis Pharmaceuticals at 9 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 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 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Uganda, Ghana, Mali, Gabon, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) (time frame: Day 29). 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 NCT03334747, 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 11 Oct 2021.