CompletedPhase 3

A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema

Japan2 participantsStarted 2021-01-15

Plain-language summary

The main aim of the study is to check for side effects from icatibant in children and teenagers with hereditary angioedema (HAE). Other aims are to check how well icatibant controls HAE symptoms in these children and teenagers, and how much icatibant stays in their blood. At the first visit, the study doctor will check if each child or teenager can take part. For those who can take part, participants and their parents or caregivers will visit the clinic or hospital when they have their next HAE attack. Participants will receive 1 injection (shot) of icatibant in a vein and will stay at the clinic or hospital until their HAE symptoms are under control. Participants can receive up to 2 more injections of icatibant over time if their HAE symptoms don't improve or get worse. After the participants go home, the study staff will follow up with them by a telephone call 1 to 2 days later. Then, the participants will visit the clinic or hospital 1 week after they received the icatabant injection. The participant can visit the clinic or hospital and be treated with icatibant in the same way for up to 3 HAE attacks in total.

Who can participate

Age range2 Years – 17 Years

SexALL

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Inclusion criteria

✓. In the opinion of the investigator or subinvestigator, the participant's parent or legal guardian is capable of understanding and complying with protocol requirements.
✓. The participant's parent or the participant's legal guardian is capable of signing and dating a written informed consent form on behalf of the participant prior to the initiation of any study procedures. Written informed assent is also obtained from the participant as much as possible.
✓. The participant is in Japan and is Japanese; defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents.
✓. The participant is male or female and 2 to \<18 years of age (ie, from the second birthday through the day prior to the eighteenth birthday) at the time of informed consent.
✓. The participant weighs \>=12 kg at the time of the current HAE attack.
✓. The participant who has a documented and confirmed diagnosis of HAE type I or II. Diagnosis may be based on historical data using the following criteria:
✓. Family history of angioedema
✓. Characteristic attack manifestations, recurrent attacks

Exclusion criteria

What they're measuring

Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAE)

Timeframe: Up to approximately 6 months

Number of Participants With Injection Site Reactions

Timeframe: Postdose, up to Day 8

Trial details

NCT IDNCT04654351

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-27

Results submitted2022-01-25

View on ClinicalTrials.gov More Hereditary Angioedema trials