Trial · NCT02411084
Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD
NCT02411084, Phase 3, Terminated, Adienne SA; results first posted 2020-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD. Trials, record NCT02411084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02411084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD
- NCT number
- NCT02411084
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- Adienne SA
- Conditions
- Graft vs Host Disease
- Interventions
- Begelomab, Conventional Second-line Treatment
- First posted
- 2015-04-08
- Last updated
- 2020-01-30
- Other registries' IDs
- eudract:2015-001360-19
- Results first posted
- 2020-01-30
- Limitations and caveats
- This clinical study has prematurely ended, due to the lack of enrollment.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Response at 28 Days | 28 days for OR | The change in grade from baseline to Study Day 28 (-1/+2 day) was used to determine the response of GvHD to treatment using the following classifications: * Complete response (CR): complete resolution of all signs of GvHD. * Partial response (PR): improvement of 1 overall grade (i.e., change from baseline in IBMTR to a less severe grading). * Stable disease (SD): No change in GvHD grading (i.e., no change from baseline in IBMTR grade). * Disease progression (PD): Deterioration in one overall grade in GvHD (i.e., worsening in IBMTR by at least 1 grade compared to baseline). * Death |
| Secondary | Number of Participants With Overall Survival (OS) up to 180 Days | Time frame is up to 180 days | For this endpoint, no statistical confirmatory test could be performed due to insufficient sample size. |
| Secondary | BEGEDINA Serum Concentrations Pre- and 15 Minutes Post-Infusion | Time frame is up to Day 28 | The pharmacokinetic (PK) objective for this study was to characterize the serum concentrations of BEGEDINA in subjects with Grades II-IV acute GvHD who have failed to respond to steroid treatment. Data was analyzed before and 15 minutes after infusion. |
| Secondary | Number of Participants With Adverse Events | The safety parameters were analysed at the end of the study period (Day 180) | The safety parameters were analysed at the end of the study period (Day 180). |
| Other | Exploratory Objectives | Time frame is up to 180 days | The exploratory objectives for this study were: * To evaluate the change in quality of life (QoL) from baseline; * To evaluate duration of response; * To evaluate OR by standard-risk and high-risk GvHD at onset |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Response at 28 Days | 28 days for OR | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Overall Survival (OS) up to 180 Days | Time frame is up to 180 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | BEGEDINA Serum Concentrations Pre- and 15 Minutes Post-Infusion | Time frame is up to Day 28 | The PK report presents the available data for 13 subjects on Begedina arm. | ng/ml | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | The safety parameters were analysed at the end of the study period (Day 180) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Exploratory Objectives | Time frame is up to 180 days | This analysis could not be performed because of the premature discontinuation of the study. No data are available |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Overall Response at 28 Days | BEGEDINA® (Begelomab) | Complete response | 3 | Participants | |
| Number of Participants With Overall Response at 28 Days | Conventional Second-line Treatment | Complete response | 5 | Participants | |
| Number of Participants With Overall Response at 28 Days | BEGEDINA® (Begelomab) | Stable Disease | 3 | Participants | |
| Number of Participants With Overall Response at 28 Days | Conventional Second-line Treatment | Stable Disease | 3 | Participants | |
| Number of Participants With Overall Response at 28 Days | BEGEDINA® (Begelomab) | Partial Response | 5 | Participants | |
| Number of Participants With Overall Response at 28 Days | Conventional Second-line Treatment | Partial Response | 8 | Participants | |
| Number of Participants With Overall Response at 28 Days | BEGEDINA® (Begelomab) | Progressive disease | 1 | Participants | |
| Number of Participants With Overall Response at 28 Days | Conventional Second-line Treatment | Progressive disease | 1 | Participants | |
| Number of Participants With Overall Survival (OS) up to 180 Days | BEGEDINA® (Begelomab) | Deceased | 13 | Participants | |
| Number of Participants With Overall Survival (OS) up to 180 Days | Conventional Second-line Treatment | Deceased | 8 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BEGEDINA® (Begelomab) | 18 | |
| Overall Study | STARTED | Conventional Second-line Treatment | 18 | |
| Overall Study | COMPLETED | BEGEDINA® (Begelomab) | 5 | |
| Overall Study | COMPLETED | Conventional Second-line Treatment | 5 | |
| Overall Study | NOT COMPLETED | BEGEDINA® (Begelomab) | 13 | |
| Overall Study | NOT COMPLETED | Conventional Second-line Treatment | 13 |
Source ClinicalTrials.gov
Adverse events492
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 | Flushing | Vascular disorders | BEGEDINA® (Begelomab) | 0 | 18 | 0 |
| other | Flushing | Vascular disorders | Conventional Second-line Treatment | 1 | 18 | 1 |
| other | Hypertension | Vascular disorders | BEGEDINA® (Begelomab) | 2 | 18 | 2 |
| other | Hypertension | Vascular disorders | Conventional Second-line Treatment | 3 | 18 | 3 |
| other | Hypotension | Vascular disorders | BEGEDINA® (Begelomab) | 3 | 18 | 3 |
| other | Hypotension | Vascular disorders | Conventional Second-line Treatment | 4 | 18 | 4 |
| other | Shock | Vascular disorders | BEGEDINA® (Begelomab) | 1 | 18 | 1 |
| other | Shock | Vascular disorders | Conventional Second-line Treatment | 0 | 18 | 0 |
| other | Deep vein thrombosis | Vascular disorders | BEGEDINA® (Begelomab) | 1 | 18 | 1 |
| other | Deep vein thrombosis | Vascular disorders | Conventional Second-line Treatment | 1 | 18 | 1 |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BEGEDINA® (Begelomab) | 13 | 18 |
| Total, all-cause mortality | Conventional Second-line Treatment | 8 | 18 |
| Total, other adverse events | BEGEDINA® (Begelomab) | 18 | 18 |
| Total, other adverse events | Conventional Second-line Treatment | 18 | 18 |
| Total, serious adverse events | BEGEDINA® (Begelomab) | 16 | 18 |
| Total, serious adverse events | Conventional Second-line Treatment | 13 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BEGEDINA® (Begelomab) vs Conventional Second-line Treatment: deaths from any cause | Trial comparisons |
| BEGEDINA® (Begelomab) vs Conventional Second-line Treatment: serious adverse events | Trial comparisons |
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/NCT02411084
GET https://conductscience.org/api/trials/v1/NCT02411084/results?page=2