Trial Outcomes & Findings for Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee (NCT NCT03349645)
NCT ID: NCT03349645
Last Updated: 2022-10-03
Results Overview
Incidence and severity of treatment emergent adverse events (TEAEs) evaluated up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
52 weeks
Results posted on
2022-10-03
Participant Flow
Subjects who had completed clinical trial AP-003C were eligible to enroll in the open label extension study. All subjects were assigned to the Ampion treatment group.
No pharmacological or non-pharmacological treatment targeting osteoarthritis (OA) started or changed 4 weeks prior to entry into the study, or likely to be changed during the duration of the study
Participant milestones
| Measure |
Ampion 4 mL Dose
4 mL Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution
|
|---|---|
|
Overall Study
STARTED
|
94
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
82
|
Reasons for withdrawal
| Measure |
Ampion 4 mL Dose
4 mL Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution
|
|---|---|
|
Overall Study
Sponsor Terminated Study
|
75
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee
Baseline characteristics by cohort
| Measure |
Ampion 4 mL Dose
n=94 Participants
4 mL Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution
|
|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intent To Treat (ITT)
Incidence and severity of treatment emergent adverse events (TEAEs) evaluated up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
Outcome measures
| Measure |
Ampion 4 mL Dose
n=94 Participants
4 mL Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution
|
|---|---|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Mild treatment-emergent adverse event (TEAE)
|
21 Events
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Moderate treatment-emergent adverse event (TEAE)
|
11 Events
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Severe treatment-emergent adverse event (TEAE)
|
2 Events
|
Adverse Events
Ampion 4 mL Dose
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ampion 4 mL Dose
n=94 participants at risk
4 mL Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution
|
|---|---|
|
Hepatobiliary disorders
Non-Alcoholic Fatty Liver
|
2.1%
2/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
2.1%
2/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
9/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
|
Musculoskeletal and connective tissue disorders
Joint Crepitation
|
2.1%
2/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
2.1%
2/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
3/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
2.1%
2/94 • 52 Weeks
Patients will be followed for the occurrence of AEs up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
|
Additional Information
Dr. Howard Levy / Chief Medical Officer
Ampio Pharmaceuticals
Phone: 7204376500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place