Trial · NCT01074944
Outcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PAP: Percentage of Participants Who Remained Stable for 52 Weeks During the PAP | PAP Baseline up to the end of PAP (Week 52) | Analysis was performed on per protocol (PP) population which included all participants who were at least 80% compliant with investigational medicinal product (IMP) dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. | percentage of participants | NUMBER |
| SECONDARY | PAP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26 and 52 | Baseline, Week 26, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively. | g/dL | MEAN |
| SECONDARY | PAP: Mean Platelet Count at Baseline, Weeks 26, 52 | Baseline, Week 26, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively. | platelets*10^9 /L | MEAN |
| SECONDARY | PAP: Mean Spleen Volume at Baseline, Weeks 26, 52 | Baseline, Week 26, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively. | MN | MEAN |
| SECONDARY | PAP: Mean Liver Volume at Baseline, Weeks 26, 52 | Baseline, Week 26 and Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. | MN | MEAN |
| SECONDARY | PAP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26 and Week 52 | Baseline, Week 26, Week 52 | PP population which all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively. | nmol/hr/mL | MEAN |
| SECONDARY | PAP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26 and Week 52 | Baseline, Week 26 and week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively. | mcg/mL | MEAN |
| SECONDARY | PAP: Mean Biomarker Macrophage Inflammatory Protein-1 Beta (MIP1-beta) Value at Baseline, Weeks 26, 52 | Baseline, Week 26, Week 52 | PP population included all participants who were at least 80% compliant with dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively. | pg/mL | MEAN |
| SECONDARY | PAP: Bone Mineral Density (BMD) at Baseline and Week 52 | Baseline, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively. | g/cm^2 | MEAN |
| SECONDARY | PAP: Total T-Scores for BMD at Baseline and Week 52 | Baseline, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively. | T-score | MEAN |
| SECONDARY | PAP: Total Z-scores for BMD at Baseline and Week 52 | Baseline, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively | Z-score | MEAN |
| SECONDARY | PAP: Number of Participants With Mobility Status Asessments (MS) at Baseline, Weeks 26, and 52. | Baseline, Week 26 and Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. | participants | NUMBER |
| SECONDARY | PAP: Number of Participants With Bone Crises at Baseline, Weeks 26 and 52 | Baseline, Week 26, and Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. | participants | NUMBER |
| SECONDARY | PAP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26 and 52 | Baseline, Week 26, and Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. | participants | NUMBER |
| SECONDARY | PAP: Total Bone Marrow Burden Score (BMB) at Baseline and Week 52 | Baseline, Week 52 | PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively. | BMB Score | MEAN |
| SECONDARY | LIP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26, 52 and 78 | Baseline, Week 26, Week, 52, and Week 78 | Analysis was performed on all treated (AT) analysis set which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points. | g/dL | MEAN |
| SECONDARY | LIP: Mean Platelet Count at Baseline, Weeks 26, 52 and 78 | Baseline, Week 26, Week 52, Week 78 | Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here 'n' signifies number of participants with available data at specified time points. | platelets*10^9 /L | MEAN |
| SECONDARY | LIP: Mean Liver Volume at Baseline, Weeks 26, 52 and 78 | Baseline, Week 26, Week 52, Week 78 | Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here, 'n' signifies number of participants with available data at specified time points. | MN | MEAN |
| SECONDARY | LIP: Mean Spleen Volume at Baseline, Weeks 26, 52 and 78 | Baseline, Week 26, Week 52, Week 78 | Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points. | MN | MEAN |
| SECONDARY | LIP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26, 52, and 78 | Baseline, Week 26, Week 52 and Week 78 | Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here 'n' signifies number of participants with available data at specified time points. | nmol/hr/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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