NCT05422365

Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Completed Phase 3 Results posted Last updated 23 September 2024

What this trial tests

Phase 3 trial testing Intravenous immunoglobulin (IVIG), 10% solution for infusion in Primary Immune Thrombocytopenia in 32 participants. Completed in 14 December 2023.

Timeline

26 July 2022

Primary endpoint
14 December 2023

14 December 2023

Quick facts

Lead sponsor	Biopharma Plasma LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	26 July 2022
Primary completion	14 December 2023
Estimated completion	14 December 2023
Sites	12 locations across Ukraine

Drugs / interventions tested

• Intravenous immunoglobulin (IVIG), 10% solution for infusion — full drug profile →

Conditions studied

• Primary Immune Thrombocytopenia — all drugs for Primary Immune Thrombocytopenia →

Sponsor

Biopharma Plasma LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Primary Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part (Percent) of Patients With Response (R) Primary · 28 days after first administration of the study drug

platelet count \>30 x 109 /l and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding

Group	Value	95% CI
Main Group	24

Part (Percent) of Patients With Complete Response (CR) Secondary · 28 days after first administration of the study drug

platelet count \>100 x 109 /l, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding. Complete response (CR) was achieved in 13 patients during the study. CR = 13/32 = 40.63 % (23,61%; 57,64%) This corresponds 40,63% from total number of patients. The confidence interval for this value is 23.61% to 57.64%

Group	Value	95% CI
Main Group	40.63	23.61 – 57.64

Part (Percent) of Patients With no Response (NR) Secondary · 28 days after first administration of the study drug

platelet count \< 30 x 109/L or less than a 2-fold increase of the baseline count. It should be confirmed by at least 2 blood tests or presence of bleeding

Group	Value	95% CI
Main Group	25	9.99 – 40

Part (Percent) of Patients With Loss of Response (R) Secondary · 28 days after first administration of the study drug

Decreasing platelet count (\< 30 x 109/L or less than a 2-fold increase of the baseline count) or development of bleeding. Platelet count should be confirmed at least two times, with an interval of 1 day.

Group	Value	95% CI
Main Group	31.25	15.19 – 47.31

Part (Percent) of Patients With Loss of Complete Response (CR) Secondary · 28 days after first administration of the study drug

decreased platelet count \<100 x 109/L or development of bleeding

Group	Value	95% CI
Main Group	13

Time (in Days) From Treatment Start to Response (R) Secondary · 28 days after first administration of the study drug

Time calculated from first infusion (treatment start) to the day when the response (R) criteria are achieved

Group	Value	95% CI
Main Group	2	2 – 3

Time (in Days) From Treatment to Complete Response (CR) Secondary · 28 days after first administration of the study drug

Time calculated from first infusion (treatment start) to the day when the complete response (CR) criteria are achieved

Group	Value	95% CI
Main Group	2	2 – 4

Duration (in Days) of Response (R) Secondary · 28 days after first administration of the study drug

Time calculated from the day when the complete response (R) criteria are achieved, to the day when loss of complete response (R) criteria is achieved

Group	Value	95% CI
Main Group	27	25 – 29

Duration (in Days) of Complete Response (CR) Secondary · 28 days after first administration of the study drug

Time calculated from the day when the complete response (CR) criteria are achieved, to the day when loss of complete response (CR) criteria are achieved

Group	Value	95% CI
Main Group	19	13 – 25

Frequency (Percent) of Adverse Events Secondary · 28 days after first administration of the study drug

Part of the drug administration cases with adverse events, from all cases of study drug administration

Group	Value	95% CI
Main Group	4

Frequency of Serious Adverse Events Secondary · 28 days after first administration of the study drug

Part of the drug administration cases with serious adverse events, from all cases of study drug administration

Group	Value	95% CI
Main Group	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Main Group

Serious: 1/32 (3%)

Deaths: 0/32

Serious adverse events (1 terms)

Reaction	System	Main Group
Vein thrombosis	Blood and lymphatic system disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Main Group
Headache	Nervous system disorders	—
Allergic reaction	General disorders	—

Most-reported serious reactions: Vein thrombosis.

Data from ClinicalTrials.gov NCT05422365 adverse events section.

Sponsor's own description

The study will involve patients with chronic immune thrombocytopenia. This disease is diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only), except for other reasons. The addition of "chronic" means that the disease lasts more than 12 months.

Patients included in the study will receive Bioven, 10% solution for infusion according to the protocol for the use of IVIG in ITP - at a dose of 0.8-1.0 g / kg 1 time per day for 2 consecutive days, the course dose of 1.6-2.0 g / kg according to the "Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG)", rev. 3, 28 June 2018. After administration of the investigational drug, patients will be under medical supervision for 28 days.

The stay of patients in the study - at least 4 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.