Health Trials

A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)

ConditionChronic Primary Immune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKedrion S.p.A.

About this trial

The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18-70 years of age.

Patient has signed the ICF.

Diagnosis of chronic (> 12 months duration) ITP as defined by the International Working Group.

Mean screening platelet count of < 30 × 10^9/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 7 days prior to screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.

Disqualifiers

Patients incapable of giving informed consent.

Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).

Patients with Evans Syndrome.

Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.

Trial design

Design model

Single group

Treatments tested in this trial

  • Kedrion IVIG 10%

    Biological/Vaccine

    (Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 2 g/kg Kedrion IVIg 10%Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of subjects with response (R)

Assess the responder rate by measuring the platelet count increase according to the Response (R) definition and the absence of bleeding during the evaluation period

Time frame
Treatment to day 14

Secondary outcomes

1

Number and rate of subjects with complete response (CR)

Assess the clinical response rate by measuring the platelet count increase and absence of bleeding according to the Complete Response (CR)

Time frame
Treatment to day 14
2

Time to platelet count response

Assess the time from starting treatment to time of achievement of CR or R

Time frame
Treatment to day 14
3

Duration of response

Measured from achievement of CR or R to loss of CR or R

Time frame
14 days after treatment to end of study
4

Regression of hemorrhages

Time to stop bleedings

Time frame
Day 1 (Visit 1) to Day 30 (End of Study Visit)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kedrion S.p.A.

Lead sponsor

Source ClinicalTrials.gov
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