Trial Outcomes & Findings for Omega-3 Fatty Acids in Sickle Cell Disease (NCT NCT02947100)

NCT ID: NCT02947100

Last Updated: 2020-10-19

Results Overview

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 6 months with continuous monitoring
• Results posted on: 2020-10-19

Participant Flow

Participant milestones

Measure	SCD-Omegatex™ single arm SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	SCD-Omegatex™ single arm SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.
Overall Study study terminated early	3
Overall Study did not meet inclusion criteria	1

Baseline Characteristics

Omega-3 Fatty Acids in Sickle Cell Disease

Baseline characteristics by cohort

Measure	SCD-Omegatex™ n=4 Participants single arm SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months with continuous monitoring

Population: Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 months

Population: Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 months

Population: Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Outcome measures

Outcome data not reported

Adverse Events

SCD-Omegatex™

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure

SCD-Omegatex™ n=4 participants at risk；n=3 participants at risk single arm SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.

Reproductive system and breast disorders Mondor's disease

100.0% 1/1 • Number of events 1 • Until one month after stopping study drug

Other adverse events

Measure	SCD-Omegatex™ n=4 participants at risk；n=3 participants at risk single arm SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.
General disorders fever	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug
Gastrointestinal disorders constipation	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug
Musculoskeletal and connective tissue disorders vasoocclusive crisis	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug
Gastrointestinal disorders nausea	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug
Eye disorders stye	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug
Skin and subcutaneous tissue disorders rash	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug
Blood and lymphatic system disorders nosebleed	33.3% 1/3 • Number of events 1 • Until one month after stopping study drug

Additional Information

Dr Robin Miller

Nemours/AI duPont Hospital

Phone: 302-651-5500

Email: rmiller@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place