NCT01434511 is a Phase 3 clinical trial of OBI-1 in Hemophilia A, sponsored by Baxalta now part of Shire.

Who is sponsoring NCT01434511?

NCT01434511 is sponsored by Baxalta now part of Shire.

What drugs are being tested in NCT01434511?

Interventions in NCT01434511: OBI-1.

What condition does NCT01434511 study?

NCT01434511 studies Hemophilia A.

Is NCT01434511 still recruiting?

NCT01434511 is currently terminated. Last updated 14 May 2021.

Are results published for NCT01434511?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-14 · How we verify

NCT01434511

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

Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A

Terminated Phase 3 Results posted Last updated 14 May 2021

What this trial tests

Phase 3 trial testing OBI-1 in Hemophilia A in 1 participant. Terminated before completion.

Timeline

3 October 2011

Primary endpoint
29 July 2013

29 July 2013

Quick facts

Lead sponsor	Baxalta now part of Shire
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	3 October 2011
Primary completion	29 July 2013
Estimated completion	29 July 2013
Sites	3 locations across South Africa, United Kingdom, United States

Drugs / interventions tested

OBI-1 — full drug profile →

Conditions studied

Hemophilia A — all drugs for Hemophilia A →

Sponsor

Baxalta now part of Shire — full company profile →

Who can join

6 and older, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with congenital hemophilia A.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Key issues in inhibitor management in patients with haemophilia.
Gomez K, Klamroth R, Mahlangu J, Mancuso ME, et al · · 2014 · cited 21× · PMID 24333092 · DOI 10.2450/2013.0246-12

Verify or expand the search:

Other trials of OBI-1

Trials testing the same drug.

NCT01178294 — Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A · Phase 2, PHASE3 · completed
NCT01968655 — Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Du · no longer available

Other recruiting trials for Hemophilia A

Currently open trials in the same condition.

NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT07416604 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A · Phase 3 · recruiting
NCT07523399 — Joint Health, Balance and Quality of Life in Adults With Hemophilia A · recruiting
NCT06833983 — To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A · Phase 3 · recruiting
NCT06579144 — Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A · Phase 1 · 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 NCT01434511 (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: 14 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/NCT01434511.

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