2024-514523-42-00RecruitingPhase 3
Comparison of inclisiran or alirocumab to standard therapy in pediatric heterozygous familial hypercholesterolemia (HeFH) – the head-to-head PICOLO-FH clinical trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2026
Brief summary (registry, in English)
Assessment the efficacy of treatment with alirocumab (S.C.) and rosuvastatin (P.O.) or inclisiran (S.C.) and rosuvastatin (P.O.), compared with standard rosuvastatin (P.O.) therapy, in achieving the therapeutic goal of LDL-C <100 mg/dl after 104 weeks of treatment in paediatric population with heterozygous familial hypercholesterolaemia.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 30 Sept 2024
- Start date
- 5 Jun 2025
- Lead sponsor
- Medical University Of Lodz
- Diseases
- Familial hypercholesterolaemia
- EU CT number
- 2024-514523-42-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any current treatment in another clinical trial or less than 30 days from the end of treatment in the other trial or 2x the half-life of the drug in the study.
- LDL - apheresis within the last month prior to inclusion in the study.
- Use of ‘ prohibited’ drugs (see section 7.2.6 of the protocol for details).
Other illness
- Uncontrolled hypertension.
Lab values
- Lipid disorders identified as secondary in the investigator's assessment due to: a. BMI ≥ 85th percentile according to the centile grids of Warsaw children (Palczewska-Niedźwiecka); b. poorly compensated diabetes mellitus, defined as HbA1c >8%; c. decompensated hypothyroidism; d. nephrotic syndrome e. anorexia f. liver dysfunction; g. other medical reasons.
- Fasting triglycerides > 350 mg/d (l>3.95 mmol/l).
- Chronic kidney disease (eGFR <30 ml/min/1.73m2).
Other
- Body weight <23kg
Who the study is looking for
- Obtain informed written consent for the patient to participate in the study, for genetic testing and for the processing of personal data.
- Age 8 - <18 years.
- LDL level from screening visit (V1): (a) LDL≥ 190 mg/dl (>4.921 mmol/L) regardless of family history or (b) LDL ≥160 mg/dl + positive family history (in first-degree relatives and/or siblings: LDL >190 mg/dl (>4.921 mmol/L) and/or with premorbid (i.e. men <55 yrs, women <60 yrs) atherosclerotic cardiovascular disease, and/or corneal stroma, and/or tendonitis) or (c) LDL ≥130 mg/dl + molecularly confirmed mutation in at least one parent and/or subject..
- Negative serum pregnancy test (beta-HCG) in menstruating girls.
- Consent to the use of contraceptive methods as described in the study protocol.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Recruiting |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland | Recruiting |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego | Lodz | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.