TriangleNCT02207556 · OUTCOME
Amyloid Organ Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 6 months and 1 year
What was measured
This measure is the number of subjects (systemic disease only) for each grade of response. Efficacy will be measured in heart, liver, or kidney. Heart N-terminal (NT)-proBNP response \>30% and \> 300 ng/L decrease in patients with baseline NT-proBNP ≥650 ng/L (Patients with progressively worsening renal function cannot be scored for NT-proBNP progression). Improvement by 2 New York Heart Association (NYHA) classes without an increase in diuretic use or in echocardiographic wall thickness ≥ 2 mm reduction in the interventricular septal thickness by echocardiogram or improvement of ejection fraction by ≥20%. Liver ≥50% decrease in an initially elevated alkaline phosphatase level, or Decrease in liver size by at least 2 cm by ultrasound. Kidney 50% reduction in 24-hour urine protein excretion (at least 0.5 g/day) without worsening of creatinine or creatinine clearance by 25% over baseline. Soft Tissue RECIST criteria will be used.
Groups in this outcome
Doxycycline (6 Months)
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
Doxycycline (1 Year)
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
| Group | Source count |
|---|---|
| Doxycycline (6 Months) | 25 |
| Doxycycline (1 Year) | 25 |
Reported measurements
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (6 Months) | 8 | Not reported | Not reported | Not reported | Not reported |
| Doxycycline (1 Year) | 3 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (6 Months) | 8 | Not reported | Not reported | Not reported | Not reported |
| Doxycycline (1 Year) | 8 | Not reported | Not reported | Not reported | Not reported |
Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (6 Months) | 6 | Not reported | Not reported | Not reported | Not reported |
| Doxycycline (1 Year) | 9 | Not reported | Not reported | Not reported | Not reported |
Expired
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (6 Months) | 3 | Not reported | Not reported | Not reported | Not reported |
| Doxycycline (1 Year) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 3
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 9
- title
- Response
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- Expired
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- This measure is the number of subjects (systemic disease only) for each grade of response. Efficacy will be measured in heart, liver, or kidney. Heart N-terminal (NT)-proBNP response \>30% and \> 300 ng/L decrease in patients with baseline NT-proBNP ≥650 ng/L (Patients with progressively worsening renal function cannot be scored for NT-proBNP progression). Improvement by 2 New York Heart Association (NYHA) classes without an increase in diuretic use or in echocardiographic wall thickness ≥ 2 mm reduction in the interventricular septal thickness by echocardiogram or improvement of ejection fraction by ≥20%. Liver ≥50% decrease in an initially elevated alkaline phosphatase level, or Decrease in liver size by at least 2 cm by ultrasound. Kidney 50% reduction in 24-hour urine protein excretion (at least 0.5 g/day) without worsening of creatinine or creatinine clearance by 25% over baseline. Soft Tissue RECIST criteria will be used.
- groups
- description
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
- id
- OG000
- title
- Doxycycline (6 Months)
- description
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
- id
- OG001
- title
- Doxycycline (1 Year)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 6 months and 1 year
- title
- Amyloid Organ Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice