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The AGAINST-PLD; An investigator-driven, randomized, open label clinical trial assessing efficacy of leuprorelin to halt disease progression in PLD

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506637-30-00
Acronym
202000894
Enrollment
36
Registered
2024-11-27
Start date
Unknown
Completion date
2025-04-30
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic liver disease

Brief summary

The primary outcome variable is liver growth rate (in % per year), calculated over the first 18 months of the trial (screening-18 months) based on liver volumes measured on MRI, comparing the direct start group and delayed start group.

Detailed description

Polycystic liver disease related complaints, using the validated PLD Questionnaire. The change in the score on the PLD Questionnaire will be compared between patients in the direct start group and the delayed start group after 18 months of treatment., Liver growth rate (in % per year) compared within individuals before start of treatment and during treatment., (Severe) Adverse events

Interventions

DRUGLEUPRORELIN

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary outcome variable is liver growth rate (in % per year), calculated over the first 18 months of the trial (screening-18 months) based on liver volumes measured on MRI, comparing the direct start group and delayed start group.

Secondary

MeasureTime frame
Polycystic liver disease related complaints, using the validated PLD Questionnaire. The change in the score on the PLD Questionnaire will be compared between patients in the direct start group and the delayed start group after 18 months of treatment., Liver growth rate (in % per year) compared within individuals before start of treatment and during treatment., (Severe) Adverse events

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026