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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004763-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Casa Sollievo della Sofferenza IRCCS | OTHER |
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Objectives:
The primary objective of this trial was to evaluate the patients response rate at the end of the study.
Patients were considered responder if one of the following conditions occurs:
Secondary objectives:
This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in steroid-dependent or mesalazine refractory patients suffering from Chron's disease (CD) or Ulcerative Colitis (UC) .
Once the patient was deemed eligible for the study, the treatment plan was selected as follows
In the Dexamethasone arm (DEX 21-P):
In the placebo arm:
Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P.
The planned duration of individual patient participation in the study was a maximum of 6 or 28 weeks, depending from the assigned treatment scheme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dex 21-P | Experimental | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. |
|
| Placebo | Placebo Comparator | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dex 21-P | Drug | At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients Responders to Dex 21-P vs Placebo | Patients were considered responder if, at the EoS, one of the following occurred:
The Powell-Tuck index was calculated by adding the subscores given by 7 items. A total score < 10 indicated a mild activity of the UC, and a total score >14 a severe one. The higher the score the worse the outcome. Crohn Disease Activity Index (CDAI) was a tool that combines subjective parameters, with objectives parameters. The score given to each parameter was inserted in an algorithm which provided the final Index value. A moderate CD showed a CDAI score between 220 and 450, while a CDAI > 450 was an activity index indicating a severe disease. | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Endogenous Cortisole Blood Level After Receiving the Study Treatment | Blood levels of endogenous cortisol were determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. As steroids suppress ACTH production resulting in lowering cortisol levels, the assessment of this parameter was intended to investigate the ability of the dexamethasone intra-erythrocytes administration in minimising this steroid adverse effect. In child, from 1 to 16 years, the total serum cortisol reference range is 5-23 mcg/dL at 8 am, and 3-13 mcg/dL at 4 pm. |
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Inclusion Criteria:
More than 18 years of age
Patients suffering from one of the following chronic inflammatory intestinal disease:
Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
Patients willing and be able to give written informed consent.
Exclusion Criteria:
Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI > 450) in patient suffering from Chron's Disease
Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature > 37.8 °C, heart rate < 90 bpm, ESR > 30 mm/h or haemoglobin < 10.5 g/dL)
Severe concurrent disease(s) as:
Treatment with Infliximab in the previous 4 months
Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
Non-collaborating patient or subject unable to regularly undergo the scheduled study procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Angelo Andriulli, MD | Casa Sollievo della Sofferenza Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa Sollievo della Sofferenza Hospital | San Giovanni Rotondo | 71013 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23714676 | Derived | Bossa F, Annese V, Valvano MR, Latiano A, Martino G, Rossi L, Magnani M, Palmieri O, Serafini S, Damonte G, De Santo E, Andriulli A. Erythrocytes-mediated delivery of dexamethasone 21-phosphate in steroid-dependent ulcerative colitis: a randomized, double-blind Sham-controlled study. Inflamm Bowel Dis. 2013 Aug;19(9):1872-9. doi: 10.1097/MIB.0b013e3182874065. |
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Thirty-three (33) outpatients were enrolled into the study: nineteen subjects were steroid dependant (8 and 11 affected from Chron's Disease and Ulcerative Colitis, respectively) while 14 were patients with Ulcerative Colitis refractory to mesalazine.
The total size of 40 patients was originally selected. However the final sample size of 33 was considered reasonable for the purpose of the study , due to the explorative nature of the protocol. Patients were assigned to a treatment plan consisting of a treatment procedure every 15 or 30 days for a total of 3 or 6 procedures, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dex 21-P | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. Dex 21-P: At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. |
| FG001 | Placebo | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. Placebo: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention to Treat population (ITT): subjects who underwent at least one treatment procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | Dex 21-P - ITT | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. Dex 21-P: At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Proportion of Patients Responders to Dex 21-P vs Placebo | Patients were considered responder if, at the EoS, one of the following occurred:
The Powell-Tuck index was calculated by adding the subscores given by 7 items. A total score < 10 indicated a mild activity of the UC, and a total score >14 a severe one. The higher the score the worse the outcome. Crohn Disease Activity Index (CDAI) was a tool that combines subjective parameters, with objectives parameters. The score given to each parameter was inserted in an algorithm which provided the final Index value. A moderate CD showed a CDAI score between 220 and 450, while a CDAI > 450 was an activity index indicating a severe disease. | ITT Population: subjects who underwent at least one treatment procedure | Posted | Count of Participants | Participants | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
TEAEs were assessed throughout the study (except at the baseline visit 1) at each access to the clinic. More specifically adverse events were assessed: - steroid-dependant patients: every 30 days up to month 6 (Final Visit) - mesalazine refractory active UC patients: every 15 days up to 45 days (Final Visit)
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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 | Dex 21-P - SAF | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. Dex 21-P: At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase of alkaline phosphatase | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene Maccabruni, M.Sc. | Quince Therapeutics (former Erydel SpA) | +39 02 36504470 | imaccabruni@quincetx.com |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
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No blinding procedures were applicable in this study which was designed as an open one.
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|
|
| Placebo | Drug | Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P |
|
| From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: Erythrocyte Sedimentation Rate (ESR) | The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. To perform the test, anticoagulated blood is traditionally placed in an upright tube (Westergren tube) and the distance which the red blood cells fall is measured and reported in millimetres at the end of one hour. ESR was evaluated as supportive data for the assessment of the intestinal disease severity. It was determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. ESR normal values in blood were from 0 to 20 mm/hour. Higher values are considered abnormal both in adults and in children. For ESR values > 100 mm/hour, there is a high probability that an underlying cause would be found upon investigation. | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: C-reactive Protein (CRP) | CRP is a protein produced by the liver. A C-reactive protein test measures the level of C-reactive protein (CRP) in a blood sample. Normal levels of blood C-reactive protein are low (0.3 to 1.0 mg/L). In case of inflammation liver releases more CRP into your bloodstream: results equal to or greater than 8 mg/L or 10 mg/L are considered high. High levels of CRP may indicate a serious health condition that causes inflammation. C-reactive protein (CRP) was determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. Inflammation parameters (CRP) were evaluated as supportive data for the assessment of the intestinal disease severity. C-reactive protein was measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L were considered high. | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Count of Partecipants, Suffering From Mesalazine Refractory UC, With Modification in Endoscopic Result (Baron Score) | The Baron score was an endoscopic grading system for ulcerative colitis. Four grades are defined (0-3) by the Baron score according to the severity of macroscopic inflammation of the rectal mucosal appearances at rigid sigmoidoscopy: 0 = normal mucosa (ramifying vascular pattern clearly visible, no spontaneous bleeding, no bleeding to light touch);
The higher the score the worst the outcome. Due to the nature of the score, its assessment was limited to patients suffering from UC, only. (CD or UC steroid-dependant patients were planned to receive the study treatment procedure every 30 days for a total of 6 administrations) | From baseline to End of treatment = 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Number of Patients Experiencing at Least One TEAE (Not Steroid-related) | At each access to the clinic (except at the baseline visit one), patients were questioned and/or examined for evidence of adverse events. An adverse event was defined as any untoward medical occurrence or unfavourable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Number of Patients Experiencing at Least One TEAE (Steroid-related) | Steroid related adverse events were investigated to assess the ability of the therapeutic approach under study in reducing the occurrence or entity of steroid adverse effects. | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
| Lost to Follow-up |
|
| BG001 | Placebo - ITT | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. Placebo: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Dex 21-P - ITT | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. Dex 21-P: At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. |
| OG001 | Placebo - ITT | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. Placebo: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P |
|
|
|
| Secondary | Change From Baseline in Endogenous Cortisole Blood Level After Receiving the Study Treatment | Blood levels of endogenous cortisol were determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. As steroids suppress ACTH production resulting in lowering cortisol levels, the assessment of this parameter was intended to investigate the ability of the dexamethasone intra-erythrocytes administration in minimising this steroid adverse effect. In child, from 1 to 16 years, the total serum cortisol reference range is 5-23 mcg/dL at 8 am, and 3-13 mcg/dL at 4 pm. | Intent To Treat population (ITT): subjects who underwent at least one treatment procedure; | Posted | Mean | Standard Deviation | mcg/dL | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
|
|
|
| Secondary | Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: Erythrocyte Sedimentation Rate (ESR) | The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. To perform the test, anticoagulated blood is traditionally placed in an upright tube (Westergren tube) and the distance which the red blood cells fall is measured and reported in millimetres at the end of one hour. ESR was evaluated as supportive data for the assessment of the intestinal disease severity. It was determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. ESR normal values in blood were from 0 to 20 mm/hour. Higher values are considered abnormal both in adults and in children. For ESR values > 100 mm/hour, there is a high probability that an underlying cause would be found upon investigation. | Intent To Treat population (ITT): subjects who underwent at least one treatment procedure | Posted | Mean | Standard Deviation | mm/h | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
|
|
|
| Secondary | Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: C-reactive Protein (CRP) | CRP is a protein produced by the liver. A C-reactive protein test measures the level of C-reactive protein (CRP) in a blood sample. Normal levels of blood C-reactive protein are low (0.3 to 1.0 mg/L). In case of inflammation liver releases more CRP into your bloodstream: results equal to or greater than 8 mg/L or 10 mg/L are considered high. High levels of CRP may indicate a serious health condition that causes inflammation. C-reactive protein (CRP) was determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. Inflammation parameters (CRP) were evaluated as supportive data for the assessment of the intestinal disease severity. C-reactive protein was measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L were considered high. | Intent To Treat population (ITT): subjects who underwent at least one treatment procedure; | Posted | Mean | Standard Deviation | mg/L | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
|
|
|
| Secondary | Count of Partecipants, Suffering From Mesalazine Refractory UC, With Modification in Endoscopic Result (Baron Score) | The Baron score was an endoscopic grading system for ulcerative colitis. Four grades are defined (0-3) by the Baron score according to the severity of macroscopic inflammation of the rectal mucosal appearances at rigid sigmoidoscopy: 0 = normal mucosa (ramifying vascular pattern clearly visible, no spontaneous bleeding, no bleeding to light touch);
The higher the score the worst the outcome. Due to the nature of the score, its assessment was limited to patients suffering from UC, only. (CD or UC steroid-dependant patients were planned to receive the study treatment procedure every 30 days for a total of 6 administrations) | Intent To Treat population (ITT): subjects who underwent at least one treatment procedure. Herein only CD or UC steroid-dependant patients were analysed. | Posted | Count of Participants | Participants | From baseline to End of treatment = 28 weeks ± 5 days (in mesalazine refractory UC patients) |
|
|
|
| Secondary | Number of Patients Experiencing at Least One TEAE (Not Steroid-related) | At each access to the clinic (except at the baseline visit one), patients were questioned and/or examined for evidence of adverse events. An adverse event was defined as any untoward medical occurrence or unfavourable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. | Safety Population: all patient included in ITT population | Posted | Count of Participants | Participants | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
|
|
|
| Secondary | Number of Patients Experiencing at Least One TEAE (Steroid-related) | Steroid related adverse events were investigated to assess the ability of the therapeutic approach under study in reducing the occurrence or entity of steroid adverse effects. | Posted | Count of Participants | Participants | From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients) |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 11 |
| 21 |
| EG001 | Placebo - SAF | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. Placebo: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P | 0 | 12 | 1 | 12 | 8 | 12 |
| Increase on gamma-glutamyl transferase | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Increase of lipase | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Increase of amylase | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Joint aspiration | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Sideropenic anemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Loss of appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Weight decrease | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rectorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Evacuations increase | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epigastralgia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tenesmus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotensive crisis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Articular pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Shiver | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
Not provided
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| From 1 to 1 score |
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| From 1 to 2 score |
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| From 2 to 1 score |
|
| From 2 to 2 score |
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| From 3 to 1 score |
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| From 3 to 2 score |
|
| From 3 to 3 score |
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