Trial · NCT01056341
Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
NCT01056341, Phase 2, Phase 3, Completed, Pierre Fabre Dermatology; results first posted 2014-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy. Trials, record NCT01056341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01056341
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
- NCT number
- NCT01056341
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 512 participants, actual
- Lead sponsor
- Pierre Fabre Dermatology
- Conditions
- Infantile Hemangioma
- Interventions
- Propranolol, Placebo
- First posted
- 2010-01-26
- Last updated
- 2015-12-10
- Results first posted
- 2014-06-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | 6 months | |
| Primary | Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. | 6 months | |
| Secondary | Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48. | 6 months | Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | 6 months | Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm. | percentage of participants | NUMBER |
| PRIMARY | Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. | 6 months | After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site. | percentage of participants | NUMBER |
| SECONDARY | Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48. | 6 months |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | Placebo | 8.0 | percentage of participants | ||
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | Propranolol 1mg/kg/d 3 Months | 9.8 | percentage of participants | ||
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | Propranolol 1 mg/kg/d 6 Months | 37.5 | percentage of participants | ||
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | Propranolol 3 mg/kg/d 3 Months | 7.7 | percentage of participants | ||
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. | Propranolol 3 mg/kg/d 6 Months | 62.8 | percentage of participants | ||
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. | Placebo | 3.6 | percentage of participants | ||
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. | Propranolol 3mg/kg/d 6 Months | 60.4 | percentage of participants |
Source ClinicalTrials.gov
Participant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | STARTED | Propranolol 1mg/kg/d 3 Months | 99 | |
| Overall Study | STARTED | Propranolol 1 mg/kg/d 6 Months | 103 | |
| Overall Study | STARTED | Propranolol 3 mg/kg/d 3 Months | 101 | |
| Overall Study | STARTED | Propranolol 3 mg/kg/d 6 Months | 102 | |
| Overall Study | Interim Analysis | Placebo | 25 | |
| Overall Study | Interim Analysis | Propranolol 1mg/kg/d 3 Months | 41 | |
| Overall Study | Interim Analysis | Propranolol 1 mg/kg/d 6 Months | 41 | |
| Overall Study | Interim Analysis | Propranolol 3 mg/kg/d 3 Months | 40 | |
| Overall Study | Interim Analysis | Propranolol 3 mg/kg/d 6 Months | 43 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events900
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchiolitis | Infections and infestations | W24-treatment Period-safety Set-Placebo | 3 | 55 | |
| other | Bronchiolitis | Infections and infestations | W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months | 5 | 98 | |
| other | Bronchiolitis | Infections and infestations | W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months | 7 | 102 | |
| other | Bronchiolitis | Infections and infestations | W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months | 5 | 100 | |
| other | Bronchiolitis | Infections and infestations | W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months | 9 | 101 | |
| other | Bronchiolitis | Infections and infestations | W72-follow-up Period of ex Placebo Group-safety Set | 2 | 33 | |
| other | Bronchiolitis | Infections and infestations | W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set | 6 | 85 | |
| other | Bronchiolitis | Infections and infestations | W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set | 4 | 91 | |
| other | Bronchiolitis | Infections and infestations | W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set | 9 | 87 | |
| other | Bronchiolitis | Infections and infestations | W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set | 11 | 95 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | W24-treatment Period-safety Set-Placebo | ||
| Total, all-cause mortality | W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months | ||
| Total, all-cause mortality | W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months | ||
| Total, all-cause mortality | W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months | ||
| Total, all-cause mortality | W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months | ||
| Total, all-cause mortality | W72-follow-up Period of ex Placebo Group-safety Set | ||
| Total, all-cause mortality | W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set | ||
| Total, all-cause mortality | W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set | ||
| Total, all-cause mortality | W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set | ||
| Total, all-cause mortality | W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01056341
GET https://conductscience.org/api/trials/v1/NCT01056341/events?page=2