A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
NCT ID: NCT03755167
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
15 participants
INTERVENTIONAL
2018-12-09
2027-02-28
Brief Summary
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The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPL344
IV IPL344 administered once a day
IPL344
IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).
Interventions
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IPL344
IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).
Eligibility Criteria
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Inclusion Criteria
2. Participants that have completed study protocol #101/2
3. A written informed consent signed prior to any study procedure being performed
4. Medically capable to undergo study procedures at the time of study entry
Exclusion Criteria
2. Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
3. Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.
4. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)
5. Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial
18 Years
75 Years
ALL
No
Sponsors
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Immunity Pharma Ltd.
INDUSTRY
Responsible Party
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Locations
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Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic
Jerusalem, , Israel
Hadassah Medical Center -Motor Neuron Disease Clinic
Jerusalem, , Israel
Countries
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Other Identifiers
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101/3
Identifier Type: -
Identifier Source: org_study_id
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