Trial · NCT01777243
A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis
NCT01777243, Phase 1, Completed, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis. Trials, record NCT01777243. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01777243
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis
- NCT number
- NCT01777243
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 25 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Amyloidosis
- Interventions
- GSK2398852, GSK2315698
- First posted
- 2013-01-28
- Last updated
- 2018-07-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of GSK2398852 as assessed by number of subjects with AEs in Part A and in Part B | Continuous throughout the study | Adverse events (AEs) will be collected from the start of Study Treatment and until the follow-up contact. |
| Primary | Safety of GSK2398852 as assessed by clinical laboratory tests in Part A and in Part B | At scheduled intervals upto Day 42 in each Part. | Safety data will include assessments of clinical laboratory tests (hematology, clinical chemistry and urinalysis). |
| Primary | Safety of GSK2398852 as assessed by vital signs measurements in Part A and in Part B | At scheduled intervals upto Day 42 in each Part. | Safety data will include measurements of vital signs (semi supine systolic and diastolic blood pressure, pulse rate and temperature measured orally). |
| Primary | Safety of GSK2398852 as assessed by ECG readings in Part A and in Part B | At scheduled intervals upto Day 42 in each Part. | Safety data will include single 12-lead electrocardiogram (ECG) readings obtained at each timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. |
| Primary | PK profile of GSK2315698 and GSK2398852 in Part A and in Part B | In Part A and Part B on Day -2, Day 1 (pre-dose, 1 hour [hr], 2 hr, 3 hr, 4 hr, 8 hr, 12 hr), Day 2, Day 3, Day 4, Day 6, Day 14, Day 21, Day 42 | Pharmacokinetic (PK) profile GSK2315698 and GSK2398852 was performed to evaluate PK of single doses of GSK2398852 and GSK2315698 when co-administered. |
| Primary | Dose response of single doses of GSK2398852 when co-administered with GSK2315698 in Part B | Baseline, Day 6, Day 14 and Day 42 in Part B. | The main measure of dose response will be determined by information from part A (and Part A extension if required). The options are: -Volume of distribution of gadolinium in the spleen as a measure of amyloid load (EqMRI); and -Liver histology examination for presence of giant cells, activation of macrophages, and amyloid clearance. |
| Secondary | SAP concentrations measurement | Baseline, Day -3, Day -2, Day -1, Day 42 in each Part. | SAP concentrations before administration of GSK2398852 will be measured using Hycult ELISA assay; and SAP concentrations after administration of GSK2398852 will be measured by GSK assay in both Parts. |
| Secondary | Measurement of anti-drug antibodies before and after treatment with GSK2398852 | Day 1 pre-dose, Day 21, Day 42 in each Part. | Anti-drug antibodies before and after treatment with GSK2398852 will be measured to assess the immunogenicity of GSK2398852 when co-administered with GSK2315698. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01777243
GET https://conductscience.org/api/trials/v1/NCT01777243/registered