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The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.
To determine if IGIV3I Grifols 10% is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:
To determine if IGIV3I Grifols 10% is safe with respect to:
Nature, severity and frequency of adverse reactions during and after infusions by percentage of subjects and percentage of infusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 treatment group with IGIV3I Grifols | Experimental | Open label, non-randomized treatment group with IGIV3I Grifols Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGIV3I Grifols | Biological | Immune Globulin Intravenous (Human) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Patients | The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L. | At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Platelet Level Reached During the Follow-up Period | Platelet count was measured at various time points in the follow-up period after infusion. | During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]) |
| Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days) |
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Inclusion Criteria:
Be aged between 18 and 82 at the time of written consent.
Have confirmed diagnosis of chronic ITP and fulfil all the following criteria:
To show a platelet count platelet count ≤ 20x10^9/L at the moment of the first infusion with the study product.
Have read the patient information and consent sheet, agreed to participate in the trial, and signed the consent sheet.
Be expected to receive treatment over 5 days and follow-up for 3 months.
For women of childbearing age, use adequate contraceptive method such as oral contraceptives, intrauterine device or tubal ligation during one-month period after the first infusion in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María Teresa Álvarez, MD | Hospital General Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Research Clinical Centre of Pediatric Hematology, Oncology and Immunology Roszdrava | Moscow | Russia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Treatment Group With IGIV3I | Open label, non-randomized treatment group with IGIV3I Grifols IGIV3I Grifols: Immune Globulin Intravenous (Human) Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Treatment Group With IGIV3I | Open label, non-randomized treatment group with IGIV3I Grifols IGIV3I Grifols: Immune Globulin Intravenous (Human) Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Patients | The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L. | All 18 subjects received at least one infusion (at any dose) of IGIV3I Grifols and were included in the intent-to-treat (ITT) population for efficacy and safety analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90). |
|
3 months
At any time during the study period (from patient´s signature of the informed consent until 3 months of follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Treatment Group With IGIV3I Grifols | Open label, non-randomized treatment group with IGIV3I Grifols IGIV3I Grifols: Immune Globulin Intravenous (Human) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment | A male subject of 54-year-old, with morbid obesity, sedentary lifestyle, previous steroid treatment and difficulty with line insertion was diagnosed with deep venous thrombosis and hospitalized. The subject recovered from the event. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment | All of these events were considered not related to the study drug |
The patient number was based on European Medicines Agency guidance to evaluate IVIG products in ITP patients (EMEA/CPMP/BPWG/388/95 rev.1, June 2000, in force when the study was designed): at least 15 subjects were sufficient for the analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marta Carretero, PhD, Clinical Project Leader | Instituto Grifols, S.A | + 34 93 571 22 00 | marta.carretero@grifols.com |
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| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The time taken for the platelet count to reach ≥ 50x10^9/L from first dose |
| At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]) |
| Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days) | Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1) | At any time during the study period (up to 3 months [90 days]) |
| Regression of Hemorrhages. | Percentage of subjects with regression of hemorrhages of Types 1 to 3:
| First 10 to14 days since the first infusion day (Day 1) |
| Frequency of Adverse Reactions During and After Infusions by Percentage of Patients | All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated. | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
| Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions | All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated. | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
| Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels) | Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator's judgment) was listed. | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
| Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA | The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
| Haematology Research Centre of Russian Academy of Medical Science |
| Moscow |
| Russia |
| Hospital General Vall d´Hebron | Barcelona | Spain |
| . Hospital de León | León | Spain |
| Hospital General Universitario La Paz | Madrid | Spain |
| Hospital Universitario La Fe | Valencia | Spain |
| Hillingdon Hospital | Middlesex | UB8 3NN | United Kingdom |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subjects with medical history of splenectomy | Number | participants |
|
| Subjects with haemorrhagic history | Number | participants |
|
| Platelet count | Median | Full Range | platelets x 10^-9/L |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Maximum Platelet Level Reached During the Follow-up Period | Platelet count was measured at various time points in the follow-up period after infusion. | The maximum platelet counts were taken from the population who responded to treatment (platelet count ≥ 50x10^9/L). If any patient received banned medication due to ITP progression during the study, the values obtained after patients received treatment were excluded. | Posted | Median | Full Range | platelets x 10^-9/L | During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]) |
|
|
|
| Secondary | Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days) | The time taken for the platelet count to reach ≥ 50x10^9/L from first dose | From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population but only 13 responded to the treatment | Posted | Median | Full Range | days | At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1]) |
|
|
|
| Secondary | Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days) | Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1) | From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population only 13 responded to the treatment | Posted | Median | Full Range | days | At any time during the study period (up to 3 months [90 days]) |
|
|
|
| Secondary | Regression of Hemorrhages. | Percentage of subjects with regression of hemorrhages of Types 1 to 3:
| ITT population: patients who received at least one infusion of the study drug | Posted | Number | 95% Confidence Interval | percentage of subjects | First 10 to14 days since the first infusion day (Day 1) |
|
|
|
| Secondary | Frequency of Adverse Reactions During and After Infusions by Percentage of Patients | All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated. | ITT population: patient who received one infusion with the study drug. | Posted | Number | percentage of patients | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
|
|
|
| Secondary | Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions | All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated. | ITT population: patient who received at least one infusion with the study drug. | Posted | Number | percentage of infusions | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
|
|
|
| Secondary | Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels) | Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator's judgment) was listed. | Intent-to-treat population | Posted | Number | participants | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
|
|
|
| Secondary | Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA | The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed | Intent-to-treat population | Posted | Number | seroconversions | At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up) |
|
|
|
| 2 |
| 18 |
| 12 |
| 18 |
|
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Systematic Assessment | A 75-year-old male with high blood glucose levels and hypertension presented a drop in hemoglobin from 11.7 g/dL to 9.8 g/dL. The reaction was transient with no complications or clinical symptoms of hemolysis. The subject was recovered from the event |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment | A 75-year-old male with high blood glucose levels and hypertension presented a drop in leukocyte count from 5.3x10^9/L to 2.7x10^9/L. The reaction was transient, with no complications. The subject was discharged from hospital totally recovered |
|
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment | Only 1 out of 11 events was considered related to the study drug |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment | It was considered related to the study drug |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment | Only 1 of the 2 events was considered related to the study drug |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment | Three out of 4 events were considered related to the study drug |
|
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment | All of 2 events were considered related to the study drug |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment | Two events were considered related to the study drug |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | One patient had 3 events that were considered not related to the study drug |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | Two patients had 2 events that were considered not related to the study drug |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | A patient had 2 events that were considered not related to the study drug |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | It was considered related to the study drug |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | It was considered related to the stuy drug |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment | Twelve out of 15 events were considered related to the study drug |
|
| Radicular syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment | It was considered related to the study drug |
|
| Haematoma | Vascular disorders | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment | Two patients had 3 events that were considered related to the study drug |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment | A patient had 2 events that were considered not related to the study drug |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment | A patient had 1 event that was considered not related to the study drug |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment | A patient had 2 events that were considered related to the study drug |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment | A patient had 1 event that was considered not related to the study drug |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
| Blood cholesterol increased | Investigations | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
| Blood triglycerides increased | Investigations | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
| Lipids abnormal | Investigations | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 15.0 | Systematic Assessment | It was considered related to the study drug |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment | A patient had 2 events that were considered not related to the study drug |
|
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment | It was considered related to the study drug |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment | It was considered not related to the study drug |
|
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| D057049 |
| Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |