Trial of Acebilustat for the Treatment of Upper Arm Lymphedema (HEAL)
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|ClinicalTrials.gov Identifier: NCT05203835|
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : August 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Lymphedema of Upper Arm||Drug: Acebilustat Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Placebo-Controlled Trial of Acebilustat (CTX-4430) for the Treatment of Human Upper Extremity Lymphedema|
|Actual Study Start Date :||July 27, 2022|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||August 31, 2025|
Experimental: Placebo and acebilustat
Participants will take acebilustat and placebo over a period of 9 months.
By mouth, once a day, 100 mg capsule
Placebo to match acebilustat by mouth, once a day
- Change from baseline in ultrasonographic measurement of dermal thickness in the affected upper extremity [ Time Frame: Baseline through week 36 ]Dermal thickness will be derived from an ultrasonographic examination of the skin of the forearm using a Terason 3200T device.
- Change from baseline in caliper measurement of dermal thickness in the affected upper extremity [ Time Frame: Baseline through week 36 ]Dermal thickness will be derived from a caliper measurement of the skin of the forearm.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Upper arm lymphedema, single arm, stage 2, greater than 6 months duration
- Male or female.
- Ages 18-75.
- If a potential participant has undergone surgical treatment, lymph node transfer, suction-assisted lipectomy, or lymphatico-venous anastamosis, at least one year must have elapsed prior to screening.
- Consistent use of an appropriately sized compression garment for daytime use.
- Willing to maintain a stable regimen of self-care from screening to end-of-study.
- Lymphedema therapy must be completed at least 8 weeks prior to screening.
- Has received Covid-19 vaccine (Pfizer, Moderna or Johnson & Johnson)
- Ability to understand and the willingness to sign a written informed consent document.
- Concurrent participation in a clinical trial of any other investigational drug or therapy
- Other medical condition that could lead to acute limb edema (e.g. acute blood clot) or other medical condition that could result in symptoms overlapping those of lymphedema (e.g. frozen shoulder).
- History of clotting disorder.
- Chronic (persistent) infection in the affected limb.
- Active cancer treatment or history of cancer treatment within the past 2 years, except for non-melanoma skin cancer or cervical cancer in-situ.
- Chronic kidney disease
- Liver disease
- Pregnancy or nursing.
- Substance abuse (e.g., alcohol or drug abuse) within 6 months prior to screening.
- Any current use of non-steroidal anti-inflammatory drug (NSAID), e.g. ibuprofen, ketoprofen) or prior therapeutic use of ketoprofen.
- Any current use of immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers) or leukotriene pathway inhibitor (zileuton), leukotriene receptor antagonist (e.g montelukast).
- Personal or family history of prolonged QT syndrome
- Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05203835
|Contact: Marissa Dobryemail@example.com|
|United States, California|
|Palo Alto, California, United States, 94305|
|Contact: Leslie Jacome-Roche, RN 650-723-1396|
|Sub-Investigator: Mark Nicolls, MD|
|Sub-Investigator: Wen Tian, PhD|
|Sub-Investigator: Xinguo Jiang, MD|
|Principal Investigator:||Stanley Rockson, MD||Stanford University|
|Responsible Party:||Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University|
|Other Study ID Numbers:||
|First Posted:||January 24, 2022 Key Record Dates|
|Last Update Posted:||August 8, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|