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← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2022-502338-20-00

HU-F-AIM - A prospective, interventional clinical study to evaluate hydroxyurea (HU) resistance in patients with polycythaemia vera who meet prediction parameters identified in the PV-AIM project using artificial intelligence

Public registry stateEnded
CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation
REGISTRY FACTS

What CTIS publishes about this trial

EUCT number
2022-502338-20-00
Trial status
Ended
Sponsor
not published
Trial region
EEA
Phase
6
Trial category
3
Low-intervention trial
no
Estimated EU start
28 July 2023
Decision date
17 May 2023
Published
05 March 2026
Estimated end
31 October 2025
EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“HU-F-AIM - A prospective, interventional study to evaluate HU-resistance in polycythemia vera patients who meet predictive parameters identified in the machine learning project PV-AIM”
Source field
authorizedApplication.authorizedPartI.trialDetails.clinicalTrialIdentifiers.fullTitle
Matched term
machine learning
“…ve, interventional clinical study to evaluate hydroxyurea (HU) resistance in patients with polycythaemia vera who meet prediction parameters identified in the PV-AIM project using artificial intelligence”
Source field
authorizedApplication.authorizedPartI.trialDetails.clinicalTrialIdentifiers.publicTitle
Matched term
artificial intelligence
“Evaluation of HU-resistance/intolerance in PV patients who meet the predictive risk factors identified in the machine learning project PV-AIM (referred to as: PV-AIM HU-resistance predictors) at start of their regular HU-treatment.”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.mainObjective
Matched term
machine learning
MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

  • Polycythemia veramarked as rare disease

Therapeutic areas

  • Diseases [C] - Neoplasms [C04]4
COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Germany

Ended
First decision
17 May 2023
Latest decision
11 September 2025
  1. Ended
  2. Ended
  3. Ended
  4. Ended
  5. Ended
  6. Ended
  7. Ended
  8. Ended
  9. Ended
  10. Ended
  11. Ended
  12. Ended
  13. Ended
  14. Ended
  15. Ended
TRIAL APPLICATIONS

Submission, decision and country state remain separate

IN

INITIAL

Authorised
Trial status
Ended
Submitted
14 February 2023
Decided
17 May 2023

Decisions17 May 2023 · Authorized

Country statusGermany · Ended

SM-1

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
31 May 2023
Decided
07 July 2023

Decisions07 July 2023 · Authorized

Country statusGermany · Ended

SM-2

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
16 October 2023
Decided
14 November 2023

Decisions14 November 2023 · Authorized

Country statusGermany · Ended

SM-3

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
19 March 2024
Decided
29 April 2024

Decisions29 April 2024 · Authorized

Country statusGermany · Ended

SM-4

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
24 October 2024
Decided
06 November 2024

Decisions06 November 2024 · Authorized

Country statusGermany · Ended

NSM-3

NON SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
27 January 2025
Decided
27 January 2025

Decisions27 January 2025 · Authorized

SM-5

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
19 February 2025
Decided
14 March 2025

Decisions14 March 2025 · Authorized

Country statusGermany · Ended

SM-6

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
07 August 2025
Decided
11 September 2025

Decisions11 September 2025 · Authorized

Country statusGermany · Ended

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

  1. Application Submitted

    Application IN · Ended

  2. Country Assessment

    Germany · Application IN · Authorized

  3. Application Status

    Application IN · Ended

  4. Country Decision

    Germany · Application IN · Authorized

  5. Application Submitted

    Application SM-1 · Ended

  6. Country Assessment

    Germany · Application SM-1 · Authorized

  7. Application Status

    Application SM-1 · Ended

  8. Country Decision

    Germany · Application SM-1 · Authorized

  9. Application Submitted

    Application SM-2 · Ended

  10. Country Assessment

    Germany · Application SM-2 · Authorized

  11. Application Status

    Application SM-2 · Ended

  12. Country Decision

    Germany · Application SM-2 · Authorized

  13. Application Submitted

    Application SM-3 · Ended

  14. Country Assessment

    Germany · Application SM-3 · Authorized

  15. Application Status

    Application SM-3 · Ended

  16. Country Decision

    Germany · Application SM-3 · Authorized

  17. Application Submitted

    Application SM-4 · Ended

  18. Country Assessment

    Germany · Application SM-4 · Authorized

  19. Application Status

    Application SM-4 · Ended

  20. Country Decision

    Germany · Application SM-4 · Authorized

  21. Application Submitted

    Application NSM-3 · Ended

  22. Application Status

    Application NSM-3 · Ended

  23. Country Decision

    Germany · Application NSM-3 · Authorized

  24. Application Submitted

    Application SM-5 · Ended

  25. Country Assessment

    Germany · Application SM-5 · Authorized

  26. Application Status

    Application SM-5 · Ended

  27. Country Decision

    Germany · Application SM-5 · Authorized

  28. Application Submitted

    Application SM-6 · Ended

  29. Country Assessment

    Germany · Application SM-6 · Authorized

  30. Application Status

    Application SM-6 · Ended

  31. Country Decision

    Germany · Application SM-6 · Authorized

  32. Trial Status Observed

    Ended

Observed by i6eal
First observed
23 Jul 2026, 13:19
Last observed
23 Jul 2026, 15:03
Materially modified
23 July 2026
RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓
i6eal (2026): EU AI Studies Monitor, CTIS trial 2022-502338-20-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2022-502338-20-00/
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