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NCT01211080: PIHS
Open-label, Uncontrolled Study of the Off Label Use of Propranolol for Infancy Hemangiomas to Identify Side Effects
trial testing Propranolol in Hemangioma in 72 participants. Completed in 1 October 2013.
1 October 2013
Quick facts
| Lead sponsor | Hannover Medical School |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 72 |
| Start date | 1 August 2008 |
| Primary completion | 1 October 2013 |
| Estimated completion | 1 October 2013 |
| Sites | 3 locations across Germany |
Drugs / interventions tested
- Propranolol (propranolol) — full drug profile →
Conditions studied
- Hemangioma — all drugs for Hemangioma →
Sponsor
Hannover Medical School
Who can join
Adults 1 Month to 8 Months, any sex, with Hemangioma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cosmesis of the lesion and surrounding skin
Time frame: Completed 8 months of life
Post treatment cosmetic and defiguration result with a hemangioma specific rating tool for categorical (color, vascularity, height, matte/shiny) and non-categorical data (visual analogue scale for overall appearance) from the Vancouver Burn Scar Scale, the Manchester Scar Scale and the Hamilton Burn scar scale by 3 examiners. -
Side effects
Time frame: Completed 8th month of life
Number of Participants with Adverse Events in the cardiovascular, bronchopulmonary and metabolic system as a Measure of Safety and Tolerability
Sponsor's own description
Propranolol use for infancy hemangiomas is of world wide interest due to low cost and presumed efficacy. The investigators hypothesized that the drug ist highly active against growing hemangiomas in problematic sites and that there are little side effects. This observational study was undertaken in an uncontrolled fashion to determine sample size, design and and tools for a later randomized controlled trial on propranolol versus physical therapy (i.e.cryotherapy) which is the most prevalent treatment for the condition. During this initial series side effects and relevant design aspects became evident which warrant expedited reporting.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neuro-immune crosstalk in cancer: mechanisms and therapeutic implications.
Pu T, Sun J, Ren G, Li H. · · 2025 · cited 34× · PMID 40456735 · DOI 10.1038/s41392-025-02241-8 -
Hypoxia-driven angiogenesis and metabolic reprogramming in vascular tumors.
Liu L, Yu J, Liu Y, Xie L, et al · · 2025 · cited 6× · PMID 40443737 · DOI 10.3389/fcell.2025.1572909 -
Abstracts der 108. Jahrestagung der Deutschen Gesellschaft für Kinder- und Jugendmedizin e.V. (DGKJ).
· 2012 · cited 1× · PMID 32226156 · DOI 10.1007/s00112-012-2738-x
Verify or expand the search:
- PubMed search for NCT01211080
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Propranolol
Trials testing the same drug.
- NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn
- NCT05741164 — Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory · Phase 2 · not yet recruiting
- NCT07352228 — Carvedilol vs. Propranolol for Preventing Rebleeding After Endoscopic Treatment of Cirrhotic Varices · Phase 4 · enrolling by invitation
- NCT07354126 — Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine · NA · recruiting
- NCT06960850 — Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin · NA · not yet recruiting
Other recruiting trials for Hemangioma
Currently open trials in the same condition.
- NCT07418294 — Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study · recruiting
Other Hannover Medical School trials
Trials by the same sponsor.
- NCT07384039 — Exercise Training in Patients With Myeloproliferative Neoplasms · NA · not yet recruiting
- NCT06740747 — Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia · NA · recruiting
- NCT06795516 — Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation · terminated
- NCT06603311 — Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of · NA · active not recruiting
- NCT06493006 — Promoting Sustainable and Active Mobility Among Employees and Students · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01211080 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hannover Medical School
- Last refreshed: 9 November 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01211080.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing