Last reviewed · How we verify
NCT01927913
Treatment of Iron Overload Requiring Chelation Therapy
Phase 2 trial testing SPD602 in Transfusional Iron Overload. Withdrawn.
30 October 2015
Quick facts
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 November 2014 |
| Primary completion | 30 October 2015 |
| Estimated completion | 30 October 2015 |
Drugs / interventions tested
- SPD602 — full drug profile →
- Deferasirox (DEFERASIROX) — full drug profile →
Conditions studied
- Transfusional Iron Overload — all drugs for Transfusional Iron Overload →
- Iron Overload — all drugs for Iron Overload →
- Iron Chelation — all drugs for Iron Chelation →
- Beta-thalassemia — all drugs for Beta-thalassemia →
Sponsor
Shire — full company profile →
Who can join
18 and older, any sex, with Transfusional Iron Overload or Iron Overload. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this open-label study is to assess liver iron concentration using MRI imaging in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the treatment of chronic transfusional iron overload.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
2015 Clinical trials update in sickle cell anemia.
Archer N, Galacteros F, Brugnara C. · · 2015 · cited 25× · PMID 26178236 · DOI 10.1002/ajh.24116 -
Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia.
Sadaf A, Hasan B, Das JK, Colan S, et al · · 2018 · cited 13× · PMID 29998494 · DOI 10.1002/14651858.cd011626.pub2 -
Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia.
Padhani ZA, Gangwani MK, Sadaf A, Hasan B, et al · · 2023 · cited 5× · PMID 37975597 · DOI 10.1002/14651858.cd011626.pub3
Verify or expand the search:
- PubMed search for NCT01927913
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SPD602
Trials testing the same drug.
- NCT01604941 — Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy · Phase 2 · terminated
- NCT01363908 — Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload · Phase 2 · terminated
Other Shire trials
Trials by the same sponsor.
- NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
- NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
- NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
- NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
- NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01927913 (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 Shire
- Last refreshed: 2 June 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/NCT01927913.
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