NCT01191372 is a Phase 1 clinical trial of ARC19499 in Hemophilia, sponsored by Baxalta now part of Shire.

Who is sponsoring NCT01191372?

NCT01191372 is sponsored by Baxalta now part of Shire.

What drugs are being tested in NCT01191372?

Interventions in NCT01191372: placebo control, ARC19499.

What condition does NCT01191372 study?

NCT01191372 studies Hemophilia.

Is NCT01191372 still recruiting?

NCT01191372 is currently terminated. Last updated 5 May 2021.

Last reviewed 2021-05-05 · How we verify

NCT01191372

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

Terminated Phase 1 Last updated 5 May 2021

What this trial tests

Phase 1 trial testing placebo control in Hemophilia in 17 participants. Terminated before completion.

Timeline

15 September 2010

Primary endpoint
28 December 2011

28 December 2011

Quick facts

Lead sponsor	Baxalta now part of Shire
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	17
Start date	15 September 2010
Primary completion	28 December 2011
Estimated completion	28 December 2011
Sites	1 location across United Kingdom

Drugs / interventions tested

placebo control
ARC19499 — full drug profile →

Conditions studied

Hemophilia — all drugs for Hemophilia →

Sponsor

Baxalta now part of Shire — full company profile →

Who can join

Adults 18 to 75, male only, with Hemophilia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Aptamers as targeted therapeutics: current potential and challenges.
Zhou J, Rossi J. · · 2017 · cited 1409× · PMID 27807347 · DOI 10.1038/nrd.2016.199
Aptamers in the Therapeutics and Diagnostics Pipelines.
Kaur H, Bruno JG, Kumar A, Sharma TK. · · 2018 · cited 243× · PMID 30128033 · DOI 10.7150/thno.25958
Current Perspectives on Aptamers as Diagnostic Tools and Therapeutic Agents.
Kumar Kulabhusan P, Hussain B, Yüce M. · · 2020 · cited 153× · PMID 32659966 · DOI 10.3390/pharmaceutics12070646
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
Molecular Selection, Modification and Development of Therapeutic Oligonucleotide Aptamers.
Yu Y, Liang C, Lv Q, Li D, et al · · 2016 · cited 49× · PMID 26978355 · DOI 10.3390/ijms17030358
Modulation of the Coagulation Cascade Using Aptamers.
Woodruff RS, Sullenger BA. · · 2015 · cited 45× · PMID 26315404 · DOI 10.1161/atvbaha.115.300131
Aptamers: Potential Diagnostic and Therapeutic Agents for Blood Diseases.
Aljohani MM, Cialla-May D, Popp J, Chinnappan R, et al · · 2022 · cited 42× · PMID 35056696 · DOI 10.3390/molecules27020383
Potential Diagnostic and Therapeutic Applications of Oligonucleotide Aptamers in Breast Cancer.
Wu X, Shaikh AB, Yu Y, Li Y, et al · · 2017 · cited 27× · PMID 28841163 · DOI 10.3390/ijms18091851

Verify or expand the search:

Other recruiting trials for Hemophilia

Currently open trials in the same condition.

NCT07579585 — Effects of Photobiomodulation in Hemophilia Patients. · NA · recruiting
NCT07406139 — PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） · Phase 4 · recruiting
NCT07285460 — A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Year · Phase 3 · recruiting
NCT07187661 — Intra-Articular Bevacizumab for Preventing Recurrent Hemarthrosis in Hemophilia With Chronic Synovitis · NA · recruiting
NCT07099313 — Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia · recruiting

Other Baxalta now part of Shire trials

Trials by the same sponsor.

NCT04985682 — A Study of ADVATE in People With Hemophilia A in India · Phase 4 · completed
NCT04578535 — A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) Wi · Phase 1 · completed
NCT04346108 — A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunode · Phase 3 · completed
NCT04158934 — A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A · active not recruiting
NCT04394286 — A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B Subjects · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01191372 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baxalta now part of Shire
Last refreshed: 5 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01191372.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing