Trial · NCT02688647
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Mean Changes in FVC From Baseline to Week 24 | 24 weeks | Changes in the mean Forced Vital Capacity (FVC) from baseline at Week 24. Normal FVC-- Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy females 20 to 60 years: 3.25 to 3.75 L |
| Primary | Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 | 24 weeks | Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24. Normal FVC%: 80% to 120% |
| Primary | Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC had the option of crossing over at 24 weeks. | Percentage of subjects with non-serious TEAEs by relationship to treatment with belumosudil, BSC, or belumosudil and BSC. Severity of TEAEs were measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 22.1 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal). |
| Primary | Safety: Percentages of Subjects With SAEs Related to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC and crossing over also up to 24 weeks of BSC. | Percentage of subjects with serious TEAEs by relationship to treatment with belumosudil and/or BSC. Investigators assessed whether events were related to treatment as possibly, probably, or definitely related. |
| Primary | Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil | Percentage of subjects with treatment-emergent adverse events (TEAEs) leading to subjects discontinuing from treatment. Investigators assessed whether TEAEs leading to discontinuation were related to study drug (possibly, probably, or definitely), belumosudil 400 mg PO QD. |
| Primary | Safety: Percentages of Subjects With Deaths Related to Study Treatment | Up to 96 weeks (Weeks 24, 8, and 96) of treatment with belumosudil. Subjects randomized to BSC also had the option of crossing over to treatment with belumosudil at 24 weeks. | Percentage of subjects with deaths by relationship to treatment with belumosudil, BSC, or belumosudil and BSC. Investigators assessed whether events were related to treatment as possibly, probably, or definitely related. |
| Secondary | Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | Changes in the mean Forced Vital Capacities (FVC) at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC. Normal FVC--Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy famles 20 to 60 years: 3.25 to 3.75 L GAP is measured by points as follows: (G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; \> 65 years = 2 points (P) Physiology: * FVC% Predicted: \> 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points * DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: \> 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points GAP Stage: * Stage I Index = 0 to 3 points * Stage II Index= 4 to 5 points * Stage III Index = 6 to 8 points |
| Secondary | Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | Changes in the mean Forced Vital Capacity (FVC) from baseline at Weeks 48 and 96, and End-of-Treatment (EOT) Normal FVC: Healthy males 20 to 60 years: 4.75 to 5.25 L; healthy females 20 to 60 years: 3.25 to 3.75 L |
| Secondary | Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | Change in the mean ratio of Forced Expiratory Volume in 1 Second (FEV1) divided by the Forced Vital Capacity (FVC) at Week 24, Week 48, Week 96, and End-of-Treatment (EOT) Normal FEV1: 80% to 120% FEV1/FVC = Within 5% of predicted ratio |
| Secondary | Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | Changes in the mean Forced Vital Capacities (FVC)% Predicted at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC. GAP is measured by points as follows: (G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; \> 65 years = 2 points (P) Physiology: * FVC% Predicted: \> 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points * DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: \> 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points GAP Stage: * Stage I = 0 to 3 points * Stage II = 4 to 5 points * Stage III = 6 to 8 points |
| Secondary | Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | Percentage of subjects exhibiting at least a 5% decrease in Forced Vital Capacity (FVC)% Predicted from baseline at Week 24, at Week 48, and at Week 96 |
| Secondary | Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | Percentage of subjects who exhibited at least a 10% decrease in Forced Vital Capacity (FVC)% Predicted from baseline at Week 24, at Week 48, and at Week 96 |
| Secondary | Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The mean change in the 6-mile Walking Distance (6MWD), i.e., the distance a subject can walk in 6 minutes, from baseline to Week 24, to Week 48, and to Week 96. Positive change = improvement; negative change = worsening |
| Secondary | Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The percentage of subjects who have at least a 50 meter improvement in the 6-mile Walking Distance (6MWD), i.e., the distance a subject can walk in 6 minutes, from baseline to Week 24, Week 48, and Week 96. |
| Secondary | Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The diffusing capacity for carbon dioxide (DLCO) is a measure of the conductance of gas transfer from inspired gas to the red blood cells. Normal DLCO is \> 75% of predicted up to 140%. Severity is generally rated as: * Mild: 60% to lower limit of normal * Moderate: 40% to 60% * Severe: \< 40% |
| Secondary | Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | Percentage of the number of subjects who exhibit less than a -15% decrease in diffusing capacity of carbon monoxide (DLCO), measured as % from baseline at Week 24, Week 48, and Week 96 The diffusing capacity for carbon dioxide (DLCO) is a measure of the conductance of gas transfer from inspired gas to the red blood cells. Normal DLCO is \> 75% of predicted up to 140%. Severity is generally rated as: * Mild: 60% to lower limit of normal * Moderate: 40% to 60% * Severe: \< 40% |
| Secondary | Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The change in Total Lung Fibrosis mean score from baseline at Weeks 24, 48, and 96. Measurements using quantitative high-resolution computerized tomography (HRCT) and include (1) extent of fibrotic abnormality; (2) fibrosis score; (3) ground glass opacity; (4) honeycombing score; (5) kurtosis of lung voxel intensity; (6) skewness of lung voxel intensity; (7) standard deviation of voxel; (8) CT total lung volume; (9) normal lung; (10) reticular score; and (11) evaluation of change on sequential scans. The Quantitative Lung Fibrosis (QLF) score measures the extent of reticular patterns with architectural distortion due to fibrosis using a support vector machine classifier. Range: 0 to 100. Higher scores imply greater impairment. |
| Secondary | Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 | Up to 96 weeks (Weeks 24, 48, and 96) | The categorical changes of lung fibrosis using subjective visual assessments by radiologists from sequential scans at baseline, Week 24, Week 48, and Week 96. Changes were categorized as: (1) much better; (2) slightly better; (3) same; (4) slightly worse; and (5) much worse. This categorization is simplified as Better (Much or Slightly); Same; and Worse (Slightly or Much). |
| Secondary | Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 | Up to 96 Weeks (Weeks 24, 48, and 96) | The change in Data-driven Texture Analysis (DTA) Lung Fibrosis mean score using sequential scans from Radiologist's Visual Reads from baseline to Weeks 24, 48, and 96. The change in DTA Lung Fibrosis mean score was measured using sequential scans from Radiologist's Visual Reads from baseline at Weeks 24, 48, and 96. DTA fibrosis score was computed as the number of Region of Interests (ROIs) classified as fibrotic divided by the total number of ROIs sampled from the lung segmentation volume. The DTA fibrosis score ranged from 0 - 100%, where higher scores indicated worsening of disease. |
| Secondary | Efficacy: Event-free Probability of Acute Exacerbation of IPF | Up to 96 weeks (Weeks 24, 48, and 96) | Acute exacerbation of IPF was defined by the following symptoms within 1 month that could not be explained by other reasons: (1) aggravated dyspnea; (2) newly discovered chest interstitial lung abnormality (by radiograph or HRCT); (3) SpO2 decrease to \< 88%. Acute exacerbation was diagnosed if Items #1 and #2 were present or if Items #1 and #3 were present and the following AEs did not occur: (A) any AE with the Preferred Term containing the word "infection" or "cardiac failure"; (B) pulmonary embolism; (C) pneumothorax. |
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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