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NCT01657552
Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects
Phase 1 trial testing Eltrombopag in Thrombocytopaenia in 56 participants. Completed in 26 October 2012.
26 October 2012
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 56 |
| Start date | 1 August 2012 |
| Primary completion | 26 October 2012 |
| Estimated completion | 26 October 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Eltrombopag (ELTROMBOPAG) — full drug profile →
- Boceprevir (BOCEPREVIR) — full drug profile →
- Telaprevir — full drug profile →
Conditions studied
- Thrombocytopaenia — all drugs for Thrombocytopaenia →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 64, any sex, with Thrombocytopaenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Erratum for Wire et al., Lack of clinically significant pharmacokinetic interaction between the thrombopoietin receptor agonist eltrombopag and hepatitis C virus protease inhibitors boceprevir and telaprevir.
Wire MB, Fang L, Hussaini A, Kleha JF, et al · · 2015 · PMID 25862822 · DOI 10.1128/aac.00567-15
Verify or expand the search:
- PubMed search for NCT01657552
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT05653219 — A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia · Phase 3 · active not recruiting
Other recruiting trials for Thrombocytopaenia
Currently open trials in the same condition.
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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 NCT01657552 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 GlaxoSmithKline
- Last refreshed: 13 November 2017
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/NCT01657552.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing