alanine has been researched along with Nasopharyngitis in 1 studies
Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.
Nasopharyngitis: Inflammation of the NASOPHARYNX, usually including its mucosa, related lymphoid structure, and glands.
Excerpt | Relevance | Reference |
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"Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection." | 9.34 | Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. ( Agarwal, K; Ahn, SH; Bae, H; Buti, M; Chan, HLY; Chen, CY; Chuang, WL; Flaherty, JF; Fung, S; Gaggar, A; Lampertico, P; Lau, A; Lim, YS; Liu, Y; Ma, X; Ramji, A; Subramanian, GM; Suri, V; Tak, WY; Tam, E; Tan, SK; Trinh, H; Wu, G; Yoon, SK, 2020) |
"Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection." | 5.34 | Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. ( Agarwal, K; Ahn, SH; Bae, H; Buti, M; Chan, HLY; Chen, CY; Chuang, WL; Flaherty, JF; Fung, S; Gaggar, A; Lampertico, P; Lau, A; Lim, YS; Liu, Y; Ma, X; Ramji, A; Subramanian, GM; Suri, V; Tak, WY; Tam, E; Tan, SK; Trinh, H; Wu, G; Yoon, SK, 2020) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 0 (0.00) | 24.3611 |
2020's | 1 (100.00) | 2.80 |
Authors | Studies |
---|---|
Lampertico, P | 1 |
Buti, M | 1 |
Fung, S | 1 |
Ahn, SH | 1 |
Chuang, WL | 1 |
Tak, WY | 1 |
Ramji, A | 1 |
Chen, CY | 1 |
Tam, E | 1 |
Bae, H | 1 |
Ma, X | 1 |
Flaherty, JF | 1 |
Gaggar, A | 1 |
Lau, A | 1 |
Liu, Y | 1 |
Wu, G | 1 |
Suri, V | 1 |
Tan, SK | 1 |
Subramanian, GM | 1 |
Trinh, H | 1 |
Yoon, SK | 1 |
Agarwal, K | 1 |
Lim, YS | 1 |
Chan, HLY | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed[NCT02979613] | Phase 3 | 490 participants (Actual) | Interventional | 2016-12-29 | Completed | ||
A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection[NCT05410496] | Phase 4 | 50 participants (Anticipated) | Interventional | 2021-06-22 | Recruiting | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 96 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 96
Intervention | mL/min (Median) |
---|---|
TAF 25 mg | 1.626 |
TDF 300 mg | 0.544 |
"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 48 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 48
Intervention | mL/min (Median) |
---|---|
TAF 25 mg | 2.240 |
TDF 300 mg | -1.722 |
The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 48
Intervention | scores on a scale (Mean) |
---|---|
TAF 25 mg | -0.02 |
TDF 300 mg | -0.01 |
The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 96
Intervention | scores on a scale (Mean) |
---|---|
TAF 25 mg | -0.03 |
TDF 300 mg | -0.03 |
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96
Intervention | percent change (Mean) |
---|---|
TAF 25 mg | 1.157 |
TDF 300 mg | 0.180 |
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48
Intervention | percent change (Mean) |
---|---|
TAF 25 mg | 0.659 |
TDF 300 mg | -0.507 |
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48
Intervention | percent change (Mean) |
---|---|
TAF 25 mg | 1.743 |
TDF 300 mg | -0.138 |
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96
Intervention | percent change (Mean) |
---|---|
TAF 25 mg | 2.330 |
TDF 300 mg | 1.726 |
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 17.9 |
TDF 300 mg | 9.0 |
HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 2.6 |
TDF 300 mg | 0.0 |
HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 5.1 |
TDF 300 mg | 2.6 |
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 1.6 |
TDF 300 mg | 2.4 |
HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 0.0 |
TDF 300 mg | 0.0 |
HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 0.8 |
TDF 300 mg | 0.4 |
The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis. (NCT02979613)
Timeframe: Weeks 48
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 96.3 |
TDF 300 mg | 96.3 |
The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 94.7 |
TDF 300 mg | 93.9 |
"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 96 analysis window and~Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 0.4 |
TDF 300 mg | 0.4 |
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 7.7 |
TDF 300 mg | 6.4 |
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 0.0 |
TDF 300 mg | 2.0 |
"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 48 analysis window and~Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TAF 25 mg | 0.4 |
TDF 300 mg | 0.4 |
The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
M = F Approach: < 20 IU/mL Target Not Detected | M = F Approach: < 20 IU/mL Target Detected | M = E Approach: < 20 IU/mL Target Not Detected | M = E Approach: < 20 IU/mL Target Detected | |
TAF 25 mg | 63.4 | 32.9 | 65.5 | 34.0 |
TDF 300 mg | 62.0 | 34.3 | 64.1 | 35.4 |
The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
M = F Approach: < 20 IU/mL Target Not Detected | M = F Approach: < 20 IU/mL Target Detected | M = E Approach: < 20 IU/mL Target Not Detected | M = E Approach: < 20 IU/mL Target Detected | |
TAF 25 mg | 65.8 | 28.8 | 69.3 | 30.3 |
TDF 300 mg | 66.1 | 27.8 | 70.1 | 29.4 |
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
Central Laboratory Criteria | AASLD Criteria | |
TAF 25 mg | 89.3 | 79.0 |
TDF 300 mg | 84.9 | 75.1 |
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) | |
---|---|---|
Central Laboratory Criteria | AASLD Criteria | |
TAF 25 mg | 88.5 | 80.7 |
TDF 300 mg | 91.4 | 86.5 |
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
Central Laboratory Criteria | AASLD Criteria | |
TAF 25 mg | 50.0 | 50.0 |
TDF 300 mg | 36.8 | 26.4 |
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96
Intervention | percentage of participants (Number) | |
---|---|---|
Central Laboratory Criteria | AASLD Criteria | |
TAF 25 mg | 56.3 | 55.8 |
TDF 300 mg | 78.9 | 73.6 |
1 trial available for alanine and Nasopharyngitis