Trial · NCT03338998

Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).

NCT03338998, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH). Trials, record NCT03338998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03338998

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
NCT number: NCT03338998
Status: Completed
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Hemorrhagic Stroke, Intracerebral Hemorrhage (ICH)
Interventions: BAF312 solution, Matching Placebo for BAF312 solution, BAF312 tablet, Matching Placebo for BAF312 tablet
First posted: 2017-11-09
Last updated: 2022-08-12
Results first posted: 2021-06-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)	On Day 14 following ICH	Following the initial diagnostic CT, repeat CT images were obtained between 24-48 h after the diagnostic scan, and on Day 7 and Day 14 to capture the trajectory of PHE increase and plateau after ICH. Only non-contrast study CT scans were obtained on Day 7 and Day 14. The non-contrast scan acquired on each patient at first follow-up (i.e. 24-48 h after the diagnostic scan) served as the baseline for our analysis. All CT scans were uploaded through a secure server, and edema and hematoma volumes were measured in a semi-automated manner by one Central Reader.
Secondary	Plasma BAF312 Concentrations	Days 1, 8, and 14	Blood samples will be collected to assess plasma concentrations.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)	On Day 14 following ICH	Per protocol analysis set	mL	GEOMETRIC_MEAN
SECONDARY	Plasma BAF312 Concentrations	Days 1, 8, and 14	Pharmacokinetics analysis set that included participants with at least one blood sample available	ng/mL	GEOMETRIC_MEAN

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
Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)	BAF312		55.09	90% Confidence Interval 42.444 to 71.509	mL
Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)	Placebo		52.50	90% Confidence Interval 40.042 to 68.835	mL
Plasma BAF312 Concentrations	BAF312	Day 1 - 0.1 Hours Post I.V. Dose n=11	0.1658	Geometric Coefficient of Variation 85.6	ng/mL
Plasma BAF312 Concentrations	BAF312	Day 1 - 2 Hours Post I.V. Dose n=11	0.5663	Geometric Coefficient of Variation 78.7	ng/mL
Plasma BAF312 Concentrations	BAF312	Day 1 - 6 Hours Post I.V. Dose n=10	2.4313	Geometric Coefficient of Variation 30.5	ng/mL
Plasma BAF312 Concentrations	BAF312	Day 8 - 0 Hours Pre Oral Dose n=11	81.9423	Geometric Coefficient of Variation 55.9	ng/mL
Plasma BAF312 Concentrations	BAF312	Day 14 - 0 Hours Pre Oral Dose n=11	36.4460	Geometric Coefficient of Variation 550.8	ng/mL

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	BAF312	16
Treatment Period	STARTED	Placebo	13
Treatment Period	COMPLETED	BAF312	8
Treatment Period	COMPLETED	Placebo	10
Treatment Period	NOT COMPLETED	BAF312	8
Treatment Period	NOT COMPLETED	Placebo	3
Safety Follow-Up Period	STARTED	BAF312	16
Safety Follow-Up Period	STARTED	Placebo	13
Safety Follow-Up Period	COMPLETED	BAF312	14
Safety Follow-Up Period	COMPLETED	Placebo	12

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events195

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
other	Anaemia	Blood and lymphatic system disorders	BAF312	0	16
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	13
other	Anaemia	Blood and lymphatic system disorders	Total	1	29
other	Leukocytosis	Blood and lymphatic system disorders	BAF312	1	16
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	0	13
other	Leukocytosis	Blood and lymphatic system disorders	Total	1	29
other	Leukopenia	Blood and lymphatic system disorders	BAF312	1	16
other	Leukopenia	Blood and lymphatic system disorders	Placebo	0	13
other	Leukopenia	Blood and lymphatic system disorders	Total	1	29
other	Lymphopenia	Blood and lymphatic system disorders	BAF312	1	16

1 to 10 of 195Source ClinicalTrials.gov

See all 195 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BAF312	0	16
Total, all-cause mortality	Placebo	0	13
Total, all-cause mortality	Total	0	29
Total, other adverse events	BAF312	14	16
Total, other adverse events	Placebo	11	13
Total, other adverse events	Total	25	29
Total, serious adverse events	BAF312	2	16
Total, serious adverse events	Placebo	2	13
Total, serious adverse events	Total	4	29

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03338998

GET https://conductscience.org/api/trials/v1/NCT03338998/events?page=2

API reference For AI assistants