An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Conditions

Hereditary angioedema

Brief summary

Number of subjects with treatment emergent adverse events (TEAEs), 2. Percentage of subjects with TEAEs, 3. TEAEs rates per injection, 4. TEAEs rates per subject year

Detailed description

1. The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study., 2. The percentage reduction and the number of subjects experiencing at least ≥ 50% ≥ 70%, ≥ 90 or equal to 100% (attack free) reduction in the time-normalized number of HAE attacks on Treatment compared to Run-in Period., 3. The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment., 4. The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment, 5. Number and percentage of subjects rating their response to therapy as good or excellent., 6. The number and percentage of subjects experiencing TEAEs with CSL312., 7. The number and percentage of subjects experiencing adverse events of special interest (AESIs) with CSL312., 8. The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths, with CSL312., 9. The number and percentage of subjects experiencing CSL312 induced anti-CSL312 antibodies with CSL312.

Related papers

No related papers found yet.

Interventions

DRUGgaradacimab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of subjects with treatment emergent adverse events (TEAEs), 2. Percentage of subjects with TEAEs, 3. TEAEs rates per injection, 4. TEAEs rates per subject year	—

Secondary

Measure	Time frame
1. The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study., 2. The percentage reduction and the number of subjects experiencing at least ≥ 50% ≥ 70%, ≥ 90 or equal to 100% (attack free) reduction in the time-normalized number of HAE attacks on Treatment compared to Run-in Period., 3. The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment., 4. The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment, 5. Number and percentage of subjects rating their response to therapy as good or excellent., 6. The number and percentage of subjects experiencing TEAEs with CSL312., 7. The number and percentage of subjects experiencing adverse events of special interest (AESIs) with CSL312., 8. The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths, with CSL312., 9. The number and percentage of	—

Measure

Time frame

1. The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study., 2. The percentage reduction and the number of subjects experiencing at least ≥ 50% ≥ 70%, ≥ 90 or equal to 100% (attack free) reduction in the time-normalized number of HAE attacks on Treatment compared to Run-in Period., 3. The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment., 4. The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment, 5. Number and percentage of subjects rating their response to therapy as good or excellent., 6. The number and percentage of subjects experiencing TEAEs with CSL312., 7. The number and percentage of subjects experiencing adverse events of special interest (AESIs) with CSL312., 8. The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths, with CSL312., 9. The number and percentage of

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Countries

Czechia, Germany, Hungary, Netherlands, Spain

Outcome results

None listed