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

Primary Purpose

Primary Immune Thrombocytopenia

Status
Recruiting
Phase
Phase 3
Locations
Ukraine
Study Type
Interventional
Intervention
Intravenous immunoglobulin (IVIG), 10% solution for infusion
Sponsored by
Biopharma Plasma LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenia focused on measuring IVIG, ITP, immunomodulatory therapy, intravenous immunoglobulin, chronic primary immune thrombocytopenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Signed Patient Informed Consent Form for participation in the study;
  • Men and women aged 18-65;
  • Confirmed primary chronic ITP (lasting > 12 months since diagnosis);
  • A full blood count should be normal except for the isolated thrombocytopenia. Patients with low hemoglobin levels (but above 90 g / l) may be included if there are symptoms of bleeding;
  • If bleeding symptoms are diagnosed, the reticulocyte count should be measured;
  • Platelet count <30 x 109 / L;
  • If the patient is taking corticosteroids, the treatment regimen/dose should be stable (at least 2 weeks prior to screening);
  • Negative pregnancy test (for women of child-bearing potential);
  • Willingness to use effective and reliable methods of contraception throughout the entire study period;
  • The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant;
  • Ability, according to the researcher, to follow all the requirements of the study protocol;

Exclusion criteria:

  • Known intolerance to plasma and immunoglobulin preparations;
  • Drug allergy or hypersensitivity to immunoglobulin preparations;
  • Confirmed deficiency of immunoglobulin A (IgA) and antibodies to IgA.
  • Contraindications to immunoglobulin administration according to the instructions for medical use;
  • Pregnancy and lactation;
  • Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);
  • Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;
  • Severe cardiovascular insufficiency (HF III);
  • History of thrombosis or presence of significant risk factors for thrombosis.
  • Patients with preventive splenectomy;
  • Hemostatic disorders other than chronic thrombocytopenia;
  • Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system;
  • Proven case of primary immunodeficiency;
  • Secondary immune thrombocytopenia;
  • Virus infections (Epstein-Barr, Cytomegalovirus, Parvovirus, Hepatitis B and C);
  • Documented HIV infection
  • Positive reaction of Wassermann (RW) test result;
  • Systemic immunopathological diseases (rheumatic diseases, nephritis, etc.);
  • Oncological diseases;
  • Diabetes mellitus;
  • Thyroid diseases;
  • History of mental illness;
  • Known drug addiction;
  • Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
  • The need to prescribe drugs that are incompatible with the administration of the drug in this study: other immunoglobulin preparations in addition to the study drug, cytostatic drugs, monoclonal antibodies, Avatrombopag);
  • Experimental treatment (e.g. Rituximab therapy) for 3 months prior to screening);
  • Blood transfusions or transfusions of blood products in the last 6 months prior to inclusion in the study;
  • Administration of IVIG 30 days prior to screening;
  • Participation in any other study currently or within the last 30 days;

Criteria for exclusion of subjects (discontinuation of treatment with the study drug):

  • Patient's wish
  • Occurrence of severe and/or unexpected Adverse events (AE) or Adverse reactions (AR) in patient during the study, that require discontinuation of the drug;
  • The need to prescribe drugs prohibited in this study.
  • Significant deterioration of the patient's condition during the study period;
  • Failure of the patient to adhere to the treatment regimen;
  • Failure of the patient to follow the procedures established under the protocol;

Sites / Locations

  • Municipal non-profit enterprise "City Clinical Hospital No. 4" of the Dnipro City Council
  • Municipal non-profit enterprise "Khmelnytskyi Regional Hospital" of the Khmelnytskyi Regional CouncilRecruiting
  • Municipal Non-Profit Enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"Recruiting
  • Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"Recruiting
  • Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"
  • Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 9" of the executive body of the Kyiv City Council (Kyiv City State Administration)Recruiting
  • "Arensia Exploratory Medicine" Limited Liability Company Medical CenterRecruiting
  • State Institution "Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine"Recruiting
  • Minicipal enterprise "Rivne regional clinical hospital" of Rivne regional council
  • Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Hospital"
  • Municipal non-profit enterprise "Ternopil University Hospital" of Ternopil Regional CouncilRecruiting
  • Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Hospital named after Andriy Novak" of Zakarpattia Regional CouncilRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Part (percent) of patients with response (R)
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

Secondary Outcome Measures

Part (percent) of patients with complete response (CR)
platelet count >100 x 109 /l, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
Part (percent) of patients with no response (NR)
platelet count < 30 x 109 /l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding
Part (percent) of patients with loss of response (R)
platelet count below 30 x 109 /l or less than 2-fold increase of baseline platelet count or bleeding; platelet counts confirmed on at least 2 separate occasions approximately 1 day apart
Part (percent) of patients with loss of complete response (CR)
platelet count below 100 x 109 /l or bleeding; platelet counts confirmed on at least 2 separate occasions approximately 1 day apart
Time (in days) from treatment start to response (R)
Time calculated from first infusion (treatment start) to the day when the response (R) criteria are achieved
Time (in days) from treatment to complete response (CR)
Time calculated from first infusion (treatment start) to the day when the complete response (CR) criteria are achieved
Duration (in days) of response (R)
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
Duration (in days) of complete response (CR)
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

Full Information

First Posted
June 14, 2022
Last Updated
November 15, 2022
Sponsor
Biopharma Plasma LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05422365
Brief Title
Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults
Official Title
Open, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of Bioven, Manufactured by Biopharma Plasma LLC, in Adult Patients With Chronic Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biopharma Plasma LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The investigational drug, IVIG, is used for immunomodulatory therapy in the treatment of autoimmune diseases. The study will involve patients with chronic immune thrombocytopenia. This autoimmune 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. Screening stage The patient or her legal representative must sign an informed consent. After the informed consent signing procedure, the patient is screened and assessed for compliance with the inclusion and non-inclusion (exclusion) criteria. Clinical stage After the patient is included in the study, according to the protocol, he/she is hospitalized and the study drug is administered at a dose of 0.8-1.0 g/kg once a day for 2 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. The final stage The blood sampling procedure to determine the above indicators will be carried out on days 7, 14, 21, and 28 after the first administration of the drug to monitor the patient's performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenia
Keywords
IVIG, ITP, immunomodulatory therapy, intravenous immunoglobulin, chronic primary immune thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open, multicenter, international, uncontrolled
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous immunoglobulin (IVIG), 10% solution for infusion
Other Intervention Name(s)
Bioven, 10% solution for infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part (percent) of patients with response (R)
Description
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
Time Frame
28 days after first administration of the study drug
Secondary Outcome Measure Information:
Title
Part (percent) of patients with complete response (CR)
Description
platelet count >100 x 109 /l, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
Time Frame
28 days after first administration of the study drug
Title
Part (percent) of patients with no response (NR)
Description
platelet count < 30 x 109 /l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding
Time Frame
28 days after first administration of the study drug
Title
Part (percent) of patients with loss of response (R)
Description
platelet count below 30 x 109 /l or less than 2-fold increase of baseline platelet count or bleeding; platelet counts confirmed on at least 2 separate occasions approximately 1 day apart
Time Frame
28 days after first administration of the study drug
Title
Part (percent) of patients with loss of complete response (CR)
Description
platelet count below 100 x 109 /l or bleeding; platelet counts confirmed on at least 2 separate occasions approximately 1 day apart
Time Frame
28 days after first administration of the study drug
Title
Time (in days) from treatment start to response (R)
Description
Time calculated from first infusion (treatment start) to the day when the response (R) criteria are achieved
Time Frame
28 days after first administration of the study drug
Title
Time (in days) from treatment to complete response (CR)
Description
Time calculated from first infusion (treatment start) to the day when the complete response (CR) criteria are achieved
Time Frame
28 days after first administration of the study drug
Title
Duration (in days) of response (R)
Description
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
Time Frame
28 days after first administration of the study drug
Title
Duration (in days) of complete response (CR)
Description
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
Time Frame
28 days after first administration of the study drug
Other Pre-specified Outcome Measures:
Title
Frequency (percent) of adverse events
Description
Part of the drug administration cases with adverse events, from all cases of study drug administration
Time Frame
28 days after first administration of the study drug
Title
Frequency of serious adverse events
Description
Part of the drug administration cases with serious adverse events, from all cases of study drug administration
Time Frame
28 days after first administration of the study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Signed Patient Informed Consent Form for participation in the study; Men and women aged 18-65; Confirmed primary chronic ITP (lasting > 12 months since diagnosis); A full blood count should be normal except for the isolated thrombocytopenia. Patients with low hemoglobin levels (but above 90 g / l) may be included if there are symptoms of bleeding; If bleeding symptoms are diagnosed, the reticulocyte count should be measured; Platelet count <30 x 109 / L; If the patient is taking corticosteroids, the treatment regimen/dose should be stable (at least 2 weeks prior to screening); Negative pregnancy test (for women of child-bearing potential); Willingness to use effective and reliable methods of contraception throughout the entire study period; The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant; Ability, according to the researcher, to follow all the requirements of the study protocol; Exclusion criteria: Known intolerance to plasma and immunoglobulin preparations; Drug allergy or hypersensitivity to immunoglobulin preparations; Confirmed deficiency of immunoglobulin A (IgA) and antibodies to IgA. Contraindications to immunoglobulin administration according to the instructions for medical use; Pregnancy and lactation; Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal); Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex; Severe cardiovascular insufficiency (HF III); History of thrombosis or presence of significant risk factors for thrombosis. Patients with preventive splenectomy; Hemostatic disorders other than chronic thrombocytopenia; Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system; Proven case of primary immunodeficiency; Secondary immune thrombocytopenia; Virus infections (Epstein-Barr, Cytomegalovirus, Parvovirus, Hepatitis B and C); Documented HIV infection Positive reaction of Wassermann (RW) test result; Systemic immunopathological diseases (rheumatic diseases, nephritis, etc.); Oncological diseases; Diabetes mellitus; Thyroid diseases; History of mental illness; Known drug addiction; Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study; The need to prescribe drugs that are incompatible with the administration of the drug in this study: other immunoglobulin preparations in addition to the study drug, cytostatic drugs, monoclonal antibodies, Avatrombopag); Experimental treatment (e.g. Rituximab therapy) for 3 months prior to screening); Blood transfusions or transfusions of blood products in the last 6 months prior to inclusion in the study; Administration of IVIG 30 days prior to screening; Participation in any other study currently or within the last 30 days; Criteria for exclusion of subjects (discontinuation of treatment with the study drug): Patient's wish Occurrence of severe and/or unexpected Adverse events (AE) or Adverse reactions (AR) in patient during the study, that require discontinuation of the drug; The need to prescribe drugs prohibited in this study. Significant deterioration of the patient's condition during the study period; Failure of the patient to adhere to the treatment regimen; Failure of the patient to follow the procedures established under the protocol;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaroslav Zhebelenko, Ph.D., MD
Phone
+380977495979
Email
y.zhebelenko@biopharma.ua
First Name & Middle Initial & Last Name or Official Title & Degree
Iryna Stavna
Email
i.stavna@biopharma.ua
Facility Information:
Facility Name
Municipal non-profit enterprise "City Clinical Hospital No. 4" of the Dnipro City Council
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Usenko
First Name & Middle Initial & Last Name & Degree
Inna Sydorenko
First Name & Middle Initial & Last Name & Degree
Iryna Selina
First Name & Middle Initial & Last Name & Degree
Anna Usenko
Facility Name
Municipal non-profit enterprise "Khmelnytskyi Regional Hospital" of the Khmelnytskyi Regional Council
City
Khmelnytskyi
ZIP/Postal Code
29010
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hryhorii Rekhtman
First Name & Middle Initial & Last Name & Degree
Oleksandra Muzyka
First Name & Middle Initial & Last Name & Degree
Zhanna Tkach
First Name & Middle Initial & Last Name & Degree
Hryhorii Rekhtman
Facility Name
Municipal Non-Profit Enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"
City
Kropyvnytskyi
ZIP/Postal Code
25030
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iryna Yermolytska
First Name & Middle Initial & Last Name & Degree
Olesia Kozachenko
First Name & Middle Initial & Last Name & Degree
Olha Imanova
Facility Name
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olena Kyselova
First Name & Middle Initial & Last Name & Degree
Mariia Mazur
First Name & Middle Initial & Last Name & Degree
Olena Karpenko
First Name & Middle Initial & Last Name & Degree
Olena Kyselova
Facility Name
Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iryna Hartovska
First Name & Middle Initial & Last Name & Degree
Hanna Drotsenko
First Name & Middle Initial & Last Name & Degree
Olha Sviatenko
First Name & Middle Initial & Last Name & Degree
Iryna Hartovska
Facility Name
Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 9" of the executive body of the Kyiv City Council (Kyiv City State Administration)
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svitlana Sivkovych
First Name & Middle Initial & Last Name & Degree
Viktoriia Starovoit
First Name & Middle Initial & Last Name & Degree
Svitlana Sivkovych
Facility Name
"Arensia Exploratory Medicine" Limited Liability Company Medical Center
City
Kyiv
ZIP/Postal Code
08112
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oksana Karnabeda
First Name & Middle Initial & Last Name & Degree
Zoreslava Lysak
First Name & Middle Initial & Last Name & Degree
Yuliia Mukhanova
First Name & Middle Initial & Last Name & Degree
Oksana Karnabeda
Facility Name
State Institution "Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine"
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zvenyslava Masliak
First Name & Middle Initial & Last Name & Degree
Tetiana Horodyska
Facility Name
Minicipal enterprise "Rivne regional clinical hospital" of Rivne regional council
City
Rivne
ZIP/Postal Code
33007
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liudmyla Khokhliuk-Alekseichuk
First Name & Middle Initial & Last Name & Degree
Nataliia Mizynets
Facility Name
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Hospital"
City
Sumy
ZIP/Postal Code
40031
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iryna Dudchenko
First Name & Middle Initial & Last Name & Degree
Pavlo Prydiuk
Facility Name
Municipal non-profit enterprise "Ternopil University Hospital" of Ternopil Regional Council
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Vybyrana
First Name & Middle Initial & Last Name & Degree
Halyna Kmita
First Name & Middle Initial & Last Name & Degree
Nadiia Khlebnikova
Facility Name
Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Hospital named after Andriy Novak" of Zakarpattia Regional Council
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurii Popovych
First Name & Middle Initial & Last Name & Degree
Olha Chundak
First Name & Middle Initial & Last Name & Degree
Myroslava Popovych

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be published after trial completion. Access to parts of the Clinical Study Report (CSR) planned after the release of scientific publications. Individual participant data (IPD) with the code of each patient will be available In CSR
IPD Sharing Time Frame
After the scientific publication of trial results, 3 months later
IPD Sharing Access Criteria
For specialists in field medicine, pharmacy, scientists
Links:
URL
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-rev-4_en.pdf
Description
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), rev. 4, 16 December 2021

Learn more about this trial

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

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