A phase 1/2 open-label, single ascending dose trial of a self-complementing optimized adeno-associated virus serotype 8 Factor IX gene therapy (AskBio009) in adults with haemophilia B

Status: Active, no longer recruiting

Phase of Trial: Phase I/II

Latest Information Update: 02 Feb 2024

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

Drugs AskBio 009 (Primary)
Indications Haemophilia B
Focus Adverse reactions; First in man
Sponsors Asklepios BioPharmaceutical; Baxalta; Baxter Healthcare Corporation; Shire

29 Jan 2024 Planned End Date changed from 28 Oct 2030 to 17 Jan 2030.
29 Jan 2024 Planned primary completion date changed from 28 Oct 2030 to 17 Jan 2030.
13 Dec 2022 Results (n=8; data cutoff of May 6, 2022) assessing the long-term safety, participant disposition, persistence of endogenous FIX R338L transgene expression; and long term persistence of neutralizing anti-capsid antibodies, presented at the 64th American Society of Hematology Annual Meeting and Exposition.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com