BridgeMD
New treatment option for Primary Immunodeficiency Diseases
Official title Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
ClinicalTrials.gov ID: NCT07346859
What this study is testing
What is BP-SCIG 20%?
BP-SCIG 20% is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for primary immunodeficiency diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- All patients will receive the investigational medicinal product BP-SCIG 20%, solution for subcutaneous administration, manufactured by BIOPHARMA PLASMA LLC. A loading dose of IMP may be required (at the Investigator's decision): at least 0.2-0.5 g/kg (1.0-2.5 mL/kg) of body weight.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 and older
You may be able to join if
- a signed informed written consent of the patient/patient's parents or legally authorised representative to take part in the study;
- children from 0 to 18 years of age, of both sexes; or adult patients: males and females older than 18 years;
- a diagnosis of primary immunodeficiency with impaired antibody production document-supported according to the ESID criteria, requiring replacement...
- patients with a body weight of no less than 9.1 kg;
- patients who received replacement therapy with intravenous immunoglobulin (IVIG) products at intervals from 21 to 28 days at the dose of 0.4-0.8...
You likely can't join if
- at the request of the patient/patient's parents/patient's legally authorised representative at any time and for any reason;
- patient developing serious and/or unexpected AEs/ARs during the study, which require discontinuation of the product;
- blood transfusions or transfusions of blood components and products, with the exception of the IMP;
- the need to use medicinal products disallowed as part of this study;
- systematic lack of patient compliance with the treatment regimen prescribed by the Investigator;
- systematic lack of patient compliance with the procedures specified in this protocol;
See the full eligibility criteria
- a signed informed written consent of the patient/patient's parents or legally authorised representative to take part in the study;
- children from 0 to 18 years of age, of both sexes; or adult patients: males and females older than 18 years;
- a diagnosis of primary immunodeficiency with impaired antibody production document-supported according to the ESID criteria, requiring replacement therapy with immunoglobulins;
- patients with a body weight of no less than 9.1 kg;
- patients who received replacement therapy with intravenous immunoglobulin (IVIG) products at intervals from 21 to 28 days at the dose of 0.4-0.8 g/kg, for at least 4 months prior to the start of the study and have total...
- absence of episodes of serious bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, visceral abscess) while taking the previous medicinal product and...
- a negative pregnancy test (in female patients with childbearing potential); readiness to use reliable methods of contraception throughout the study period;
- patient's ability, in the Investigator's judgement, to comply with all the requirements of the study protocol.
- at the request of the patient/patient's parents/patient's legally authorised representative at any time and for any reason;
- patient developing serious and/or unexpected AEs/ARs during the study, which require discontinuation of the product;
- blood transfusions or transfusions of blood components and products, with the exception of the IMP;
- the need to use medicinal products disallowed as part of this study;
- systematic lack of patient compliance with the treatment regimen prescribed by the Investigator;
- systematic lack of patient compliance with the procedures specified in this protocol;
- exclusion based on screening results, including emergence of episodes of serious bacterial infections while receiving a previous IV immunoglobulin product and episodes of hospitalisation during the screening period...
- Receiving the IMP BP-SCIG 20% for less than 4 months;
- Presence of episodes of serious bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, visceral abscess) at the time of investigation of PK parameters.
The study team makes the final eligibility decision.
Where it's taking place
- Cherkasy, Ukraine
- Chernivtsi, Ukraine
- Ivano-Frankivsk, Ukraine
- Kyiv, Ukraine
- Lutsk, Ukraine
- Lviv, Ukraine
- Rivne, Ukraine
- Vinnytsia, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cherkasy, Ukraine; Chernivtsi, Ukraine; Ivano-Frankivsk, Ukraine; Kyiv, Ukraine; Lutsk, Ukraine; Lviv, Ukraine and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.