Trial · NCT05281328
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height-adjusted Total Liver Volume (htTLV) | From screening until treatment week 53 | Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage. |
| Secondary | PLD Symptom (PLD-S) Score | From screening to Week 53 | Change from baseline to Week 53 in the PLD-S measure score. |
| Secondary | htTLV | From screening until treatment weeks 13, 25, 77, 125 and 173 | Change from baseline in htTLV as determined by MRI volumetry |
| Secondary | PLD-S | From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173 | Change from baseline in the PLD-S measure score |
| Secondary | Height-adjusted Total Kidney Volume (htTKV) | From screening until treatment weeks 13, 25, 53, 77, 125 and 173 | Change from baseline in htTKV as determined by MRI volumetry |
| Secondary | Total Liver Cyst Volume | From screening to treatment weeks 13, 25, 53, 77, 125 and 173 | Change from baseline in total liver cyst volume determined by MRI volumetry |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173 | Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C |
| Secondary | PLD Impact (PLD-I) Score | From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 | Change from baseline in the PLD-I measure score |
| Secondary | Clinical Global Impression of Severity (CGI-S) Score | From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173 | Change from baseline in the CGI-S score |
| Secondary | Patient Global Impression of Severity (PGI-S) Score | From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 | Change from baseline in the PGI-S score |
| Secondary | Patient Global Impression of Change (PGI-C) Score | At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 | Change from baseline in the PGI-C score |
| Secondary | Short Form-36 (SF-36) Score | From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173 | Change from baseline in the SF-36 score |
| Secondary | Polycystic Liver Disease Questionnaire (PLD-Q) | From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173 | Change from baseline in the PLD-Q score |
| Secondary | Adverse Events (AEs) | From screening to the safety follow-up, assessed up to approximately 47 months. | Incidence of AEs |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05281328/registered