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NCT01323985
SAP Depleter Dose Escalation Study in Healthy Volunteers
Phase 1 trial testing GSK2315698 in Amyloidosis in 21 participants. Completed in 30 June 2011.
30 June 2011
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 6 January 2011 |
| Primary completion | 30 June 2011 |
| Estimated completion | 30 June 2011 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- GSK2315698 — full drug profile →
- GSK2315698 — full drug profile →
Conditions studied
- Amyloidosis — all drugs for Amyloidosis →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 65, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to provide safety information and to define the optimal induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in healthy volunteers prior to assessing in patients
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis.
Nuvolone M, Nevone A, Merlini G. · · 2022 · cited 23× · PMID 36094752 · DOI 10.1007/s40259-022-00550-w -
Target Mediated Drug Disposition Model of CPHPC in Patients with Systemic Amyloidosis.
Sahota T, Berges A, Barton S, Cookson L, et al · · 2015 · cited 9× · PMID 26225229 · DOI 10.1002/psp4.15
Verify or expand the search:
- PubMed search for NCT01323985
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GSK2315698
Trials testing the same drug.
- NCT01777243 — A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis · Phase 1 · completed
- NCT01406314 — SAP Depleter Dose Assessment Study in Patients · Phase 1 · completed
Other recruiting trials for Amyloidosis
Currently open trials in the same condition.
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT06974877 — Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure · Phase 1 · recruiting
- NCT07081646 — A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloido · Phase 1, PHASE2 · recruiting
- NCT07232459 — [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
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 NCT01323985 (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 GlaxoSmithKline
- Last refreshed: 21 July 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/NCT01323985.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing