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An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa (CHAPAS-5)

24. august 2026 opdateret af: University College, London

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa

The goal of the CHAPAS-5 clinical trial is to find out how well different HIV treatments work in children and young people (from 4 weeks up to under 15 years old) living with HIV, including those starting treatment for the first time and those whose current treatment is not working well.

The study aims to learn whether newer or different combinations of medicines can better control the virus, be safer, and be easier to take.

The main questions it aims to answer are:

  • Can these treatments help children stay alive and keep their HIV virus at very low levels (viral load below 400) after 48 weeks?
  • Which treatment options are most effective, safest, and easiest for children and their carers to use?

Researchers will compare different treatment groups to see if some medicines work better than others. Participants will be given one of several HIV treatment combinations (all already used in care), and these will be compared to see if they lead to:

  • Better control of HIV
  • Fewer side effects
  • Improved quality of life

Participants will:

  • Be randomly assigned (like flipping a coin by computer) to one suitable HIV treatment
  • Take their HIV medication every day as prescribed
  • Attend clinic visits over about 1-2 years

At these visits, they will:

  • Have blood tests to check HIV levels and general health
  • Have health check-ups (e.g. weight, symptoms, side effects)

  • Answer simple questionnaires about:

    • How easy the treatment is to take
    • Mood, sleep, and wellbeing
    • Quality of life
  • Receive support to help them take their medication regularly

Some participants may also take part in optional extra studies (for example, to understand how the drugs work in the body).

Overall, this study aims to identify the best HIV treatments for children and young people, so future care can be more effective, safer, and easier to follow.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

CHAPAS-5 is a study organised by an international group of researchers from the United Kingdom, Uganda, Mozambique, Zimbabwe, Italy and the Netherlands.

Background HIV is a virus that attacks the cells that help the body fight infection. This means that a person living with HIV may be more likely to become ill as they are not able to fight off other infections and cope with other illnesses. HIV is usually treated by taking three or four different medicines. Some of these medicines can be combined into one tablet. Depending on the medicines used, tablets may need to be taken either once or twice every day. The medicine is called antiretroviral therapy (ART).

The goal of HIV treatment is to make sure the HIV virus in the blood remains very low; this is called virological suppression. If this goal is achieved and sustained life-long, then people with HIV infection can live a healthy life, with a normal life expectancy. Adults living with HIV have many treatment options. This means that they can change treatments more easily if they get side-effects or if a treatment stops working.

Children and adolescents living with HIV have fewer available treatments than adults and only limited alternatives if they develop side-effects or if their current treatment stops working. As HIV treatment needs to be life-long for a person to live a long, healthy and productive life, it is really important that better treatment options are made available to children and adolescents.

A clinical trial is a study that compares different treatments to find out which works best. Traditional trials usually compare only two treatments at a time. CHAPAS-5 uses a newer trial design that can compare several treatments at the same time in two different groups of children. It will test three treatment options for children and adolescents starting ART for the first time (ART-naïve), and four options for those already on ART whose current treatment is not working well (ART-experienced).

Which treatments are being compared?

  1. Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) - naive and experienced
  2. Dolutegravir/tenofovir alafenamide/emtricitabine (DTG/TAF/FTC) - naive and experienced
  3. Dolutegravir/lamivudine (DTG/3TC) - naive
  4. Darunavir/ritonavir (DRV/r) + tenofovir alafenamide/emtricitabine (TAF/FTC) - experienced
  5. Darunavir/ritonavir (DRV/r) + abacavir/lamivudine (ABC/3TC) - experienced

Additional treatments, such as long-acting injectables, may be added to the trial as they become available. These could remove the need for daily pills and help improve adherence.

Who can join the trial? CHAPAS-5 will enrol participants in Uganda, Zimbabwe, and Mozambique.

The study includes children and adolescents aged at least 4 weeks to less than 15 years and weighing 3 to less than 30kg who:

  • Are starting ART for the first time, or
  • Are already on DTG-based ART but their HIV is not suppressed, and
  • Have at least two treatment options in the trial that their doctor considers suitable for them.

What will be measured?

  • How well the virus is controlled using a blood test called the viral load
  • Side effects from the treatment
  • How well children are able to take their treatment as prescribed
  • How easy the treatment is to take and how well it fits into daily life
  • Mental health and quality of life
  • The costs of different treatment options and how cost-effective they are

Participants are followed for at least 48 weeks.

Novel design CHAPAS-5 uses a novel design called the Personalised Randomised Controlled Trial (PRACTical) design. This means that each participant will be randomly allocated to receive a treatment from a list which contains only the treatment options that are appropriate for them. The treatments will be ranked from best performing to worst performing based on how well they work for participants. This will researchers to identify which treatments work best for different groups of children.

Why this trial matters? CHAPAS-5 aims to identify the best treatments for children that work well and are easy to take, with fewer side effects. The trial will also evaluate point-of-care CD4 testing to speed up diagnosis and treatment for children with advanced HIV disease and assess targeted resistance testing to identify those who may need to change treatment.

Broader Implications CHAPAS-5 not only tests different treatment options but aims to speed up the testing of HIV treatments for children so that better options can become available more quickly. The trial findings will help inform national and international guidelines and country treatment policies. This could improve future HIV treatment options for children and adolescents living with HIV.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
800

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

INCLUSION CRITERIA:

  1. Aged ≥ 4 weeks to <15 years* with confirmed HIV infection
  2. Weight ≥3kg and <30kg*
  3. Written informed consent obtained (and assent if applicable)

  4. Willing to adhere to a minimum of 48 weeks' follow-up

    • Upper limits of 15 years and 30kg are for initial treatment options and may be amended when further treatment options are introduced (through a protocol amendment)

ART-NAÏVE

  1. Planning to start first-line ART
  2. Virologically unsuppressed with VL ≥400 c/mL at screening

ART-EXPERIENCED

  1. ART-experienced, and on DTG-based ART, and have been on DTG-based ART for at least 6-months prior to screening
  2. Virologically unsuppressed for at least 3 months, demonstrated by two consecutive VLs ≥400 c/mL in the last year; the second VL must be at screening
  3. Received adherence counselling as per standard practice prior to screening

EXCLUSION CRITERIA

  1. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR both ALT ≥3xULN and bilirubin ≥2xULN at screening**
  2. Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  3. Severe renal impairment, defined as creatinine clearance <30 mL/min/1.73m2, at screening**
  4. Severe life-threatening illness (not expected to survive beyond two weeks) as determined by the investigator's clinical judgment.
  5. Eligible for less than two permitted treatment options based on tables 3 (ART-naive participants) and 4 (ART-experienced participants)

  6. Concurrent participation in another clinical trial of an investigational medicinal product (IMP), medical device or other intervention.

    • If ALT, bilirubin or creatinine results are available before randomisation and meet exclusion criteria, the child should not be randomised. However, randomisation may proceed while awaiting these results. If results become available after randomisation and meet exclusion criteria, the participant must be recalled and withdrawn from the trial and the InCTU trial physician contacted to discuss clinical management.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: ART Naïve DTG/ABC/3TC
ART Naïve participants receiving dolutegravir, abacavir, lamivudine
Medicin: Dolutegravir (DTG)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Abacavir (ABC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Lamivudine (3TC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Eksperimentel: ART Naïve DTG/TAF/FTC
ART Naïve participants receiving dolutegravir, tenofovir alafenamide, emtricitabine
Medicin: Dolutegravir (DTG)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Tenofovir alafenamide (TAF)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Emtricitabine (FTC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Eksperimentel: ART Naïve DTG/3TC
ART Naïve participants receiving dolutegravir, lamivudine
Medicin: Dolutegravir (DTG)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Lamivudine (3TC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Eksperimentel: ART Experienced DTG/ABC/3TC
ART Experienced participants receiving dolutegravir, abacavir, lamivudine
Medicin: Dolutegravir (DTG)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Abacavir (ABC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Lamivudine (3TC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Eksperimentel: ART Experienced DTG/TAF/FTC
ART Experienced participants receiving dolutegravir, tenofovir alafenamide, emtricitabine
Medicin: Dolutegravir (DTG)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Tenofovir alafenamide (TAF)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Emtricitabine (FTC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Eksperimentel: ART Experienced DRV/r /ABC/3TC
ART Experienced participants receiving darunavir, ritonavir, abacavir, lamivudine
Medicin: Abacavir (ABC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Lamivudine (3TC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Darunavir (DRV)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Ritonavir (RTV)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Eksperimentel: ART Experienced DRV/r /TAF/FTC
ART Experienced participants receiving darunavir, ritonavir, tenofovir alafenamide, emtricitabine
Medicin: Tenofovir alafenamide (TAF)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Emtricitabine (FTC)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Darunavir (DRV)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.
Medicin: Ritonavir (RTV)
Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The proportion of participants alive with HIV VL <400 c/mL at 48 weeks
Tidsramme: Week 48
For participants with an initial week 48 VL ≥400 copies/mL, a repeat VL is required, and the repeat value will be used for outcome classification.
Week 48

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The proportion of participants alive with HIV VL<1000 c/mL at 48 weeks
Tidsramme: Week 48
For participants with an initial week 48 VL ≥400 copies/mL, a repeat VL is required, and the repeat value will be used for outcome classification.
Week 48
The proportion of participants with cross-sectional HIV VL ≥50 copies/mL, ≥400 copies/mL, and ≥1000 copies/mL at 48 weeks
Tidsramme: Week 48
Using the single VL measurement closest to the week 48 timepoint within the analysis window (will include blips and confirmed measures).
Week 48
The proportion of participants with emergent drug resistance by 48 weeks
Tidsramme: Week 48
Week 48
Time to first serious adverse events (SAEs), grade ≥3 adverse events (AEs) and ART-modifying events of any grade
Tidsramme: From randomisation to the last study visit (minimum of 48 weeks)
From randomisation to the last study visit (minimum of 48 weeks)
Time to first new or recurrent WHO 3/4 events, or death
Tidsramme: From randomisation to the last study visit (minimum of 48 weeks)
From randomisation to the last study visit (minimum of 48 weeks)
Change in CD4 count and CD4 percentage from baseline to week 48
Tidsramme: From baseline to week 48
From baseline to week 48
Change in weight and BMI-for-age from baseline to week 48
Tidsramme: From baseline to week 48
From baseline to week 48

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence and acceptability
Tidsramme: From baseline to last study visit (minimum 48 weeks)

Participant or parent/carer reported adherence to trial medications via a short series of questions (Adherence Questionnaire).

Participant or parent/carer reported acceptability of trial medications using the Paediatric Oral Medicine Acceptability Questionnaire (POMAQ).
From baseline to last study visit (minimum 48 weeks)
Depression, anxiety, suicidality and sleep
Tidsramme: From baseline to last study visit (minimum 48 weeks)
Participant or parent/carer reported depression, anxiety and sleep using a trial-specific Mood and Sleep questionnaire. Participant or parent/carer reported suicidality at screening using the C-SSRS (Columbia-Suicide Severity Rating Scale) Screener questionnaire.
From baseline to last study visit (minimum 48 weeks)
Quality of Life using EQ-5D-Y-5L
Tidsramme: From baseline to last study visit (minimum 48 weeks)
Participant and parent/carer reports of health-related quality-of-life using the EuroQol-5 Dimension (EQ-5D) questionnaire. This questionnaire includes a scale of 0-100 where a higher score means a better outcome.
From baseline to last study visit (minimum 48 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
University College, London

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Radboud University Medical Center
Baylor College of Medicine
Makerere University
University of York
PENTA Foundation
Eduardo Mondlane University
Joint Clinical Research Centre- Kampala
Centre for Sexual Health and HIV/AIDS Research Zimbabwe
University of Zimbabwe Clinical Research Centre (UZCRC)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. november 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. juni 2029

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. december 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
29. juli 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
24. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
28. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
28. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
24. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • CHAPAS-5

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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