Trial Outcomes & Findings for Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults (NCT NCT05422365)

NCT ID: NCT05422365

Last Updated: 2024-09-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: 28 days after first administration of the study drug
• Results posted on: 2024-09-23

Participant Flow

Participant milestones

Measure	Main Group Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants
Age, Continuous	41 years n=32 Participants
Sex: Female, Male Female	25 Participants n=32 Participants
Sex: Female, Male Male	7 Participants n=32 Participants
Region of Enrollment Ukraine	26 participants n=32 Participants
Region of Enrollment Turkey	6 participants n=32 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Part (Percent) of Patients With Response (R)

24 Participants

SECONDARY outcome

Timeframe: 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%

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Part (Percent) of Patients With Complete Response (CR)

40.63 percentage of participants Interval 23.61 to 57.64

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Part (Percent) of Patients With no Response (NR)

25 percentage of participants Interval 9.99 to 40.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Part (Percent) of Patients With Loss of Response (R)

31.25 percentage of participants Interval 15.19 to 47.31

SECONDARY outcome

Timeframe: 28 days after first administration of the study drug

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

Outcome measures

Measure

Main Group n=13 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Part (Percent) of Patients With Loss of Complete Response (CR)

13 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Time (in Days) From Treatment Start to Response (R)

2 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Time (in Days) From Treatment to Complete Response (CR)

2 days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=24 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Duration (in Days) of Response (R)

27 days Interval 25.0 to 29.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=13 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Duration (in Days) of Complete Response (CR)

19 days Interval 13.0 to 25.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Frequency (Percent) of Adverse Events

4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure

Main Group n=32 Participants Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Frequency of Serious Adverse Events

1 Participants

Adverse Events

Main Group

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure

Main Group n=32 participants at risk Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Blood and lymphatic system disorders Vein thrombosis

3.1% 1/32 • Number of events 1 • 28 days Definitions of adverse events is similar to clinicaltrials.gov

Other adverse events

Measure	Main Group n=32 participants at risk Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance. Intravenous immunoglobulin (IVIG), 10% solution for infusion: The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.
Nervous system disorders Headache	9.4% 3/32 • Number of events 3 • 28 days Definitions of adverse events is similar to clinicaltrials.gov
General disorders Allergic reaction	3.1% 1/32 • Number of events 1 • 28 days Definitions of adverse events is similar to clinicaltrials.gov

Additional Information

Igor Rudenko, Clinical Research Physician

Biopharma Plasma LLC

Phone: +380503300865

Email: i.rudenko@biopharma.ua

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place