Trial Outcomes & Findings for Intranasal Heparin Tolerability Study (NCT NCT04490239)
NCT ID: NCT04490239
Last Updated: 2021-04-30
Results Overview
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 1000 U intranasal dose of heparin
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
6 participants
Primary outcome timeframe
24 hours after a 1000 U intranasal dose of heparin
Results posted on
2021-04-30
Participant Flow
Participant milestones
| Measure |
Experimental Arm
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
1000 U Acute (One Dose, Day 1)
STARTED
|
6
|
|
1000 U Acute (One Dose, Day 1)
COMPLETED
|
6
|
|
1000 U Acute (One Dose, Day 1)
NOT COMPLETED
|
0
|
|
2000 U Acute (One Dose, Day 3)
STARTED
|
6
|
|
2000 U Acute (One Dose, Day 3)
COMPLETED
|
6
|
|
2000 U Acute (One Dose, Day 3)
NOT COMPLETED
|
0
|
|
2000 U Chronic (Daily, 14 Days)
STARTED
|
6
|
|
2000 U Chronic (Daily, 14 Days)
COMPLETED
|
6
|
|
2000 U Chronic (Daily, 14 Days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Heparin Tolerability Study
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 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
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after a 1000 U intranasal dose of heparinA measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 1000 U intranasal dose of heparin
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1
participants with normal aPTT (24-33 sec)
|
6 Participants
|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1
participants with abnormal aPTT (<24 sec or >33 sec)
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 hours after 2000 U dose intranasal heparinA measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 2000 U intranasal dose of heparin
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2
Participants with normal aPTT (24-33 sec)
|
6 Participants
|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2
Participants with abnormal aPTT (<24 sec or >33 sec)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 14, chronic phaseA measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained immediately after the 14 consecutive day of daily 2000 U dose of intranasal heparin
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14
Participants with normal aPTT (24-33 sec)
|
6 Participants
|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14
Participants with abnormal aPTT (<24 sec or >33 sec)
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the last 2000 U dose of the chronic phaseA measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained 24 hours after the 14 consecutive day of daily 2000 U dose of intranasal heparin
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15
Participants with normal aPTT (24-33 sec)
|
6 Participants
|
|
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15
Participants with abnormal aPTT (<24 sec or >33 sec)
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose baseline, Day 14 chronic phaseIndicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase.
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Percent Change in Platelet Count From Pre-dose Baseline
|
2.2 percent change from baseline
Interval -3.2 to 7.6
|
PRIMARY outcome
Timeframe: Day 0 through Day 2, acute phaseNumber of incidents of blood coming from the nose during the acute phase
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Incidents of Epistaxis, Acute Phase
|
0 Reported incidents
|
PRIMARY outcome
Timeframe: Day 1 through Day 15, chronic phaseBlood coming from the nose or pink tinged nasal secretions
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Incidents of Epistaxis, Chronic Phase
|
1 Reported incidents
|
PRIMARY outcome
Timeframe: Day 14, Chronic PhaseAbnormally low platelet counts indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase.
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14
Participants with normal platelet counts (150,000 - 450,000 platelets/uL)
|
6 Participants
|
|
Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14
Participants with abnormal platelet counts (<150,000 or >450,000 platelets/uL)
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 through Day 2, acute phaseReports of mild, short-lived nasal irritation immediately after administration including mild burning sensation
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Other Adverse Effects, Acute Phase
|
2 Reported incidents
|
SECONDARY outcome
Timeframe: Day 1 through Day 15, chronic phaseReports of mild, short-lived nasal irritation immediately after administration including mild burning sensation, itchiness or sneezing
Outcome measures
| Measure |
Experimental Arm
n=6 Participants
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Other Adverse Effects, Chronic Phase
|
5 Reported incidents
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Arm
n=6 participants at risk
Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.
Intranasal heparin sodium (porcine): Intranasal heparin sodium
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mild nasal irritation lasting less than 1 min after administration
|
33.3%
2/6 • Number of events 7 • From date of first dose in acute phase through sixteen days after last dose in chronic phase; 38 days total
Adverse event collection was obtained by vital sign measurement, INR measurements from blood collection, and subject self-reporting
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 2 • From date of first dose in acute phase through sixteen days after last dose in chronic phase; 38 days total
Adverse event collection was obtained by vital sign measurement, INR measurements from blood collection, and subject self-reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place