Trial Outcomes & Findings for A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP) (NCT NCT01390649)

Results Overview

The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

Within 3 days of infusion

Results posted on

2016-04-08

Participant Flow

Screening occurred within 6 days before treatment with IgPro10 (Privigen). Subjects who met all of the inclusion criteria and none of the exclusion criteria could be enrolled into the study. Of 58 eligible subjects, one withdrew consent before treatment and 57 subjects received at least 1 dose of Privigen.

Participant milestones

Participant milestones
Measure	IgPro10 IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
Overall Study STARTED	57
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	IgPro10 IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
Overall Study Physician Decision	1

Baseline Characteristics

A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IgPro10 n=57 Participants IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 13.10 • n=99 Participants
Sex: Female, Male Female	37 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants

PRIMARY outcome

Timeframe: Within 3 days of infusion

The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 days after the first infusion

Population: Full analysis set: all subjects who received at least 1 IgPro10 infusion.

The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10\^9/L after the first IgPro10 administration).

Outcome measures

Outcome measures
Measure	IgPro10 n=57 Participants IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
Responder Rate	74 percentage of participants Interval 61.0 to 83.0

Adverse Events

IgPro10

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IgPro10 n=57 participants at risk IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
Blood and lymphatic system disorders Immune Thrombocytopenic Purpura	1.8% 1/57 • Number of events 1 • For the duration of individual subject participation in the study, up to approximately 35 days.

Other adverse events

Other adverse events
Measure	IgPro10 n=57 participants at risk IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
Nervous system disorders Headache	29.8% 17/57 • Number of events 23 • For the duration of individual subject participation in the study, up to approximately 35 days.
General disorders Pyrexia	5.3% 3/57 • Number of events 6 • For the duration of individual subject participation in the study, up to approximately 35 days.

Additional Information

Clinical Trial Disclosure Manager

CSL Behring

Phone: Use email contact

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER