Trial Outcomes & Findings for Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite) (NCT NCT03526549)
NCT ID: NCT03526549
Last Updated: 2023-09-08
Results Overview
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
483 participants
Primary outcome timeframe
Up to Day 1080
Results posted on
2023-09-08
Participant Flow
Rollover participants from the parent studies, EN3835-302 or EN3835-303 (CCH-aaes-treated or placebo-treated) were unblinded at Day 180 (after observation phase) and only participants who received active CCH-aaes remained in this Open-label Phase of the study.
Participant milestones
| Measure |
CCH-aaes Treatment in Parent Studies EN3835-302/303
Participants who received CCH-aaes treatment in the parent studies were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase entered the Open-label Phase. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
Placebo Treatment in Parent Studies EN3835-302/303
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued.
|
|---|---|---|
|
180 Days Observational Phase
STARTED
|
243
|
240
|
|
180 Days Observational Phase
Completed Day 180
|
243
|
240
|
|
180 Days Observational Phase
COMPLETED
|
202
|
0
|
|
180 Days Observational Phase
NOT COMPLETED
|
41
|
240
|
|
Open-label Phase
STARTED
|
202
|
0
|
|
Open-label Phase
CCH-aaes Retreatment
|
55
|
0
|
|
Open-label Phase
COMPLETED
|
104
|
0
|
|
Open-label Phase
NOT COMPLETED
|
98
|
0
|
Reasons for withdrawal
| Measure |
CCH-aaes Treatment in Parent Studies EN3835-302/303
Participants who received CCH-aaes treatment in the parent studies were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase entered the Open-label Phase. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
Placebo Treatment in Parent Studies EN3835-302/303
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued.
|
|---|---|---|
|
180 Days Observational Phase
Participants who Received Placebo in Parent Studies were Discontinued
|
0
|
238
|
|
180 Days Observational Phase
Withdrawal by Subject
|
40
|
2
|
|
180 Days Observational Phase
Lost to Follow-up
|
1
|
0
|
|
Open-label Phase
Adverse Event
|
4
|
0
|
|
Open-label Phase
Withdrawal by Subject
|
54
|
0
|
|
Open-label Phase
Lost to Follow-up
|
35
|
0
|
|
Open-label Phase
Other than Specified
|
5
|
0
|
Baseline Characteristics
Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
Baseline characteristics by cohort
| Measure |
Overall Participants
n=483 Participants
Participants who received CCH-aaes or placebo treatment in the parent studies were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase entered the Open-label Phase. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals and participants who received placebo during the parent studies were discontinued.
|
|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
483 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
382 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Other
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Multiple
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
|
393 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.00 kg/m^2
STANDARD_DEVIATION 7.108 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 1080Population: Day 180 Observation Phase Population included all rollover participants who completed the parent studies (EN3835-302 or EN3835-303) (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=243 Participants
Participants who received CCH-aaes in the parent studies, were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
n=240 Participants
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
n=202 Participants
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
n=55 Participants
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
58 Participants
|
29 Participants
|
43 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: From Day 180 (Open-label Phase) up to Day 1080Population: Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes. Participants who received placebo during the parent studies did not continue in the Open-label Phase.
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
Outcome measures
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=202 Participants
Participants who received CCH-aaes in the parent studies, were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
n=55 Participants
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
|
98.2 percentage of participants
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 180 (Open-label Observation Phase) up to Day 1080Population: Participants who were treated with CCH-aaes and had a 2-level composite response in CR-PCSS and PR-PCSS in the parent studies and who consented to continue in the Open-label Phase of this study. Participants who had a 2-level reduction in response in CR-PCSS and PR-PCSS were to be assessed for time to event.
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in PR-PCSS and CR-PCSS to the time at which a 2-level composite worsening of response was observed for the first time.
Outcome measures
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=20 Participants
Participants who received CCH-aaes in the parent studies, were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
Time to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
|
NA days
No participants had a 2-level reduction in response so it was not possible to calculate a time to a 2-level reduction in response.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 180 (Open-label Observation Phase) up to Day 1080Population: This assessment includes both 1-level and 2-level composite responders in the parent studies who had a 1-level reduction of response in CR-PCSS and PR-PCSS.
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which 1-level composite worsening of response was observed for the first time.
Outcome measures
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=24 Participants
Participants who received CCH-aaes in the parent studies, were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS
|
356.5 days
Standard Deviation 232.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 180 (Open-label Observation Phase) up to Day 1080Population: This assessment includes both 1-level and 2-level composite responders in the parent studies who had complete loss of response in CR-PCSS and PR-PCSS.
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Complete loss of response is defined as both CR-PCSS and PR-PCSS ratings returned to the baseline severity of the double-blind study or worse for both the buttocks. Time to complete loss of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which complete loss of response was observed for the first time.
Outcome measures
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=6 Participants
Participants who received CCH-aaes in the parent studies, were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
Time to Complete Loss of Response in CR-PCSS and PR-PCSS
|
238.2 days
Standard Deviation 85.75
|
—
|
—
|
—
|
Adverse Events
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Open-label Phase (Prior to Retreatment)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Open-label CCH-aaes Retreatment Phase
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=243 participants at risk
Participants who received CCH-aaes in the parent studies were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
n=240 participants at risk
Participants who received placebo in the parent studies were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
n=202 participants at risk
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
n=55 participants at risk
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
Infections and infestations
Meningitis viral
|
0.41%
1/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.42%
1/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.50%
1/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.50%
1/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.50%
1/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.50%
1/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
1.8%
1/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
1.8%
1/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
1.8%
1/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
1.8%
1/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
Other adverse events
| Measure |
Day 180 Observation Phase: CCH-aaes Treatment in Parent Studies EN3835-302/303
n=243 participants at risk
Participants who received CCH-aaes in the parent studies were followed for 180 days of observation with no treatment.
|
Day 180 Observation Phase: Placebo Treatment in Parent Studies EN3835-302/303
n=240 participants at risk
Participants who received placebo in the parent studies were followed for 180 days of observation with no treatment.
|
Open-label Phase (Prior to Retreatment)
n=202 participants at risk
Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and who consented to continue in the Open-label Phase of the study.
|
Open-label CCH-aaes Retreatment Phase
n=55 participants at risk
Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
|
|---|---|---|---|---|
|
General disorders
Injection site bruising
|
4.9%
12/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
56.4%
31/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site discolouration
|
4.1%
10/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.99%
2/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
7.3%
4/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
2.5%
5/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
5.5%
3/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site pain
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
18.2%
10/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site pruritus
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
16.4%
9/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site erythema
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
10.9%
6/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site nodule
|
1.2%
3/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
7.3%
4/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site swelling
|
0.41%
1/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
7.3%
4/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site haemorrhage
|
0.41%
1/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
5.5%
3/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
|
General disorders
Injection site induration
|
0.00%
0/243 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/240 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
0.00%
0/202 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
5.5%
3/55 • Up to Day 1080
Day 180 Observation Phase Population included all rollover participants who completed the parent studies (CCH-aaes-treated or placebo-treated). Open-label Phase Population included participants who received CCH-aaes in the parent study and who consented to continue in the Open-label Phase of the study. Open-label CCH-aaes Retreatment Population included participants in the Open-label Phase who qualified for, and opted for, retreatment with CCH-aaes.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place