Trial · NCT00943111
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period | Baseline up to Week 52 | For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in multiples of normal \[MN\]). Stable hematological parameters were defined as hemoglobin level did not decrease more than (\>) 1.5 gram per deciliter (g/dL) from baseline and platelet count did not decrease \>25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase \>25% from baseline, if applicable, and liver volume (in MN) did not increase \>20% from baseline. |
| Primary | Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP | Week 52 up to week 208 | For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in MN). Stable hematological parameters were defined as hemoglobin level did not decrease \>1.5 g/dL from baseline and platelet count did not decrease \>25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase \>25% from baseline, if applicable, and liver volume did not increase \>20% from baseline. |
| Secondary | Total T-Scores for Bone Mineral Density | Baseline | Images of the spine and bilateral femur were obtained by dual energy X-Ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score greater than \[\>\]-1), osteopenia (score -2.5 to less than or equal to \[\<=\] -1), and osteoporosis (score \<= -2.5). |
| Secondary | Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 52 | Baseline, Week 52 | Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score \>-1), osteopenia (score -2.5 to \<=-1), and osteoporosis (score \<= -2.5). Absolute change = T-score at Week 52 minus T-score at baseline. |
| Secondary | Total Z-Scores for Bone Mineral Density | Baseline | Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score \>-2) and below normal (score \<=-2). |
| Secondary | Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 52 | Baseline, Week 52 | Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score \>-2) and below normal (score \<=-2). Absolute change = Z-score at Week 52 minus Z-score at baseline. |
| Secondary | Hemoglobin Level | Baseline | |
| Secondary | Absolute Change From Baseline in Hemoglobin Levels at Week 52 | Baseline, Week 52 | Absolute change = hemoglobin level at Week 52 minus hemoglobin level at baseline. |
| Secondary | Percent Change From Baseline in Platelet Counts at Week 52 | Baseline, Week 52 | Percent change in platelet counts = (\[platelet count at Week 52 minus platelet count at baseline\] divided by \[platelet count at baseline\]) multiplied by 100. |
| Secondary | Percent Change From Baseline in Spleen Volume (MN) at Week 52 | Baseline, Week 52 | Percent change in spleen volume = (\[spleen volume at Week 52 minus spleen volume at baseline\] divided by \[spleen volume at baseline\]) multiplied by 100, where all volumes are in MN. |
| Secondary | Percent Change From Baseline in Liver Volume (in MN) at Week 52 | Baseline, Week 52 | Percent change in liver volume = (\[liver volume at Week 52 minus liver volume at baseline\] divided by \[liver volume at baseline\]) multiplied by 100, where all volumes are in multiples of normal. |
| Secondary | Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 208 | Baseline, Week 208 | Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score \>-1), osteopenia (score -2.5 to \<=-1), and osteoporosis (score \<= -2.5). Absolute change = T-score at Week 208 minus T-score at baseline. |
| Secondary | Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 208 | Baseline, Week 208 | Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score \>-2) and below normal (score \<=-2). Absolute change = Z-score at Week 208 minus Z-score at baseline. |
| Secondary | Absolute Change From Baseline in Hemoglobin Levels at Week 208 | Baseline, Week 208 | Absolute change = hemoglobin level at Week 208 minus hemoglobin level at baseline. |
| Secondary | Percent Change From Baseline in Platelet Counts at Week 208 | Baseline, Week 208 | Percent change in platelet counts = (\[platelet count at Week 208 minus platelet count at baseline\] divided by \[platelet count at baseline\]) multiplied by 100. |
| Secondary | Percent Change From Baseline in Spleen Volume (in MN) at Week 208 | Baseline, Week 208 | Percent change in spleen volume = (\[spleen volume at Week 208 minus spleen volume at baseline\] divided by \[spleen volume at baseline\]) multiplied by 100, where all volumes are in MN. |
| Secondary | Percent Change From Baseline in Liver Volume (in MN) at Week 208 | Baseline, Week 208 | Percent change in liver volume = (\[liver volume at Week 208 minus liver volume at baseline\] divided by \[liver volume at baseline\]) multiplied by 100, where all volumes are in multiples of normal. |
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.
For software
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