adenine and Infections, Respiratory

adenine has been researched along with Infections, Respiratory in 2 studies

Research

Studies (2)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Change From Baseline in eGFR-CG at Week 96

"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

Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48

"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

Change From Baseline in FibroTest® Score at Week 48

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

Change From Baseline in FibroTest® Score at Week 96

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

Percent Change From Baseline in Hip BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Percentage of Participants With HBeAg Loss at Week 96

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

Percentage of Participants With HBeAg Seroconversion at Week 48

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

Percentage of Participants With HBeAg Seroconversion at Week 96

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

Percentage of Participants With HBsAg Loss at Week 96

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

Percentage of Participants With HBsAg Seroconversion at Week 48

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

Percentage of Participants With HBsAg Seroconversion at Week 96

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

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48

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

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96

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

Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm

"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

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48

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

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

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

Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

"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

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48

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

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96

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

Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)

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

Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)

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

Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)

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

Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)

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

Trials

2 trials available for adenine and Infections, Respiratory