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An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Experimental | Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly | Drug | IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia | During receipt of study treatment on the trial. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Cornfeld, MD, MPH | Idera Pharmaceuticals, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 twice weekly per Protocol 8400-401 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Adverse Events | Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia | Safety population | Posted | Count of Participants | Participants | During receipt of study treatment on the trial. |
|
|
During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
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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 | IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Idera Medical Monitor | Idera Pharmaceuticals, Inc. | 617-679-5500 | clinicaltrials@iderapharma.com |
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| ID | Term |
|---|---|
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000719091 | bazlitoran |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| Conjunctival hemorrhage | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Injection site discoloration | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |